Establish a Medical Device Startup Company

Establish a Medical Device Startup Company

Introduction: Medical device startups play an essential role in revolutionizing patient care and improving quality of life. If you share our passion for innovation, starting a medical device company could prove rewarding yet challenging – this article offers comprehensive guidance to help get one started.

Tips to start a Medical Device Startup Company

1. Brainstorm an Engaging Idea:

Every successful medical device startup begins with an original idea. Start by researching the healthcare industry and identifying unmet needs or potential gaps in existing solutions; engaging healthcare providers, clinicians and patients for insights to gain further understanding;  engaging healthcare providers, clinicians/patients for insight.

Having this insight allows for creative problem-solving ideas which meet genuine needs while offering commercial viability potential.

2. Conduct Market Research:

Once your idea is developed, conduct extensive market research to gauge its viability. Consider factors like target market size and competition analysis; reimbursement policies consideration; pricing strategies investigation and market adoption factors as part of this analysis process.

Conducting such research will allow you to refine and assess the commercial potential of your idea while making more informed decisions in your startup journey.

3. Create an Effective and Diverse Team:

A strong and diverse team is critical to the success of any medical device startup. Bring on board experts with experience in product development, clinical research, marketing and finance; find individuals passionate about your mission with skills to overcome any hurdles; partner with advisors, consultants and industry professionals in order to leverage their knowledge and networks.

Establishing your product in multiple markets successfully relies heavily on finding an experienced regulatory partner who can collaborate on this endeavor.

4. Create a Prototype and Proof of Concept:

Give life to your vision by developing a prototype and proof of concept. This step involves translating engineering designs to functional prototypes and conducting preliminary tests – common challenges medical device startups encounter during this step include prioritizing features that set their product apart while iterating upon user, expert, and advisor feedback to refine its design according to user input received; additionally it’s wise to keep regulatory requirements front of mind to ensure compliance from day one.

5. Navigating the Regulatory Landscape:

Navigating and understanding the regulatory environment are integral parts of starting a medical device company, and OMC Medical’s team of regulatory affairs specialists can offer invaluable assistance here.

They know exactly what steps are necessary to gain regulatory clearance or approval for your medical device – their knowledge of FDA or CE marking requirements can help streamline this path, saving time and resources while ensuring compliance.

6. Secure Funding:

Producing a medical device from concept to commercialisation requires significant financial resources. In order to secure funding sources such as angel investors, venture capitalists, government grants and crowdfunding platforms – identify them beforehand by conducting due diligence processes with potential angel or venture investors before creating your pitch deck and business plan outlining market potential, competitive advantages and financial projections; develop relationships with prospective investors as you prepare for due diligence processes with them; seek guidance from experienced entrepreneurs or join incubator and accelerator programs offering funding options;

7. Establish a Go-to-Market Strategy:

Craft an inclusive go-to-market plan, covering marketing, sales and distribution channels. Create key opinion leaders as supporters for your product or service; employ digital marketing strategies or attend industry trade shows as means of increasing awareness while sparking interest; establish distribution channels to guarantee efficient product reach among target users.

8. Adopt Continuous Learning and Innovation:

For success in today’s ever-evolving medical device industry, cultivating a culture of continuous learning and innovation is paramount. Keep abreast of research findings, technological advancements, regulatory requirements and feedback from users and healthcare professionals on ways your product could be enhanced further; adjust accordingly in response to market dynamics and user needs in order to sustain growth over time.

Conclusion: Starting a medical device company requires innovation, persistence and careful strategic planning. By following these steps and drawing upon the experience and knowledge of industry experts, you can successfully navigate the complexities of the healthcare industry and develop groundbreaking medical devices that improve patient outcomes while contributing to expanding healthcare overall.

Finding an exciting medical device startup idea requires extensive research and investigation. Here are a few sources and methods that may help you uncover an impressive concept to move your vision forward:

Market Research:

Conduct market research to identify unfulfilled needs, gaps or challenges within the medical device industry. Assess current trends, emerging technologies and market dynamics while noting any areas where existing solutions fall short or innovative approaches could greatly enhance performance.

Market research tools available around the globe are invaluable resources for medical device startups. Here are a few commonly utilized ones:

  •  Statista: Statista is a user-friendly market research platform providing access to various statistics, market reports, industry studies on medical devices as well as consumer trends across numerous fields such as medicine.
  •  GlobalData is an industry leader in business intelligence and market research reports, offering in-depth analyses, forecasts and insights into the medical device industry – covering market trends, competitive landscape and emerging technologies.
  •  PHE Statistics: PHE provides regional-specific healthcare system NHS data platforms available worldwide.
  •  NHS Knowledge and Library Hub: Here you will find full-text versions of books, journal articles and access to NHS libraries of resources.
  •  PubMed: PubMed is an acclaimed database for biomedical literature research. With access to an expansive archive of research articles, clinical studies, and scientific publications related to medical devices, healthcare technologies and therapies – making it an indispensable source for keeping abreast of recent advancements in healthcare research and therapeutic advancement – PubMed can be used as an invaluable source for keeping abreast with recent innovations.
  •  IBISWorld: IBISWorld offers industry reports, market analyses and company profiles covering multiple industries – including medical devices. Their essays cover market trends, performance metrics and growth forecasts that provide invaluable market intelligence.
  • Google Trends: By using Google Trends, it is possible to gain an in-depth view of keyword popularity and search volume trends for medical device-related words or topics over time. With this tool at your disposal, it can provide valuable insights into market demand, consumer interest patterns and emerging trends relating to medical devices.
  • Euromonitor International: Euromonitor International offers market research reports and analyses across multiple industries, such as healthcare and medical devices. Their reports provide insight into market size, competitive landscape, consumer behaviour in various regions as well as regional differences.
  •  MedTech Innovator: MedTech Innovator is an international platform that presents medical device startups and provides insights into emerging technologies and innovations within the medical device industry. Additionally, this platform provides market trends, investor perspectives, networking events and networking opportunities.

These tools can assist you in gathering market data, industry trends and competitor analysis so you can make educated decisions regarding your medical device startup. Be sure to supplement them with primary research, expert interviews and validation from potential users for a complete understanding of the market.

1. Healthcare Professionals and Experts: For insights and perspectives from relevant healthcare professionals in providing healthcare and patient care services. These discussions may reveal what challenges healthcare professionals encounter when providing patient care services; their feedback could point out areas where medical devices could make significant impacts in real-life scenarios – sometimes direct action may be the key to success!

2. Addressing Patient Needs and Experiences: Pay close attention to patient needs and experiences by gathering stories, engaging with patient advocacy groups, conducting surveys or interviews and carefully listening for answers about challenges, limitations or ways medical devices could enhance quality of life or healthcare outcomes.

3. Solicit Feedback From Potential Users: Collect feedback from prospective users such as healthcare professionals, patients, caregivers and any other stakeholders involved with producing your medical device through interviews, focus groups or surveys in order to discover their pain points, preferences and desires for improved medical devices. Pay close attention as prospective users may provide invaluable feedback that can shape your idea while meeting end user requirements.

4. Technology and Innovation Hubs: Explore technology and innovation hubs such as startup incubators, accelerators or research centres dedicated to medical devices or healthcare. These hubs may offer resources, mentorship and networking opportunities with industry professionals and investors; engaging with these communities could open your mind up to new perspectives and foster creative problem-solving techniques.

5. Literature Review and Intellectual Property Analysis: When conducting a literature review related to medical devices, conduct an intensive analysis of all existing research, patents, scientific publications and intellectual property pertaining to them. This can provide insights into areas where significant advances have been made or where innovation may be necessary; intellectual property analysis also sheds light on untapped opportunities or possible areas for differentiation.

Keep in mind that coming up with an innovative idea requires research, creativity and industry knowledge. Be open to gathering varying viewpoints while validating your concepts through market research or feedback from others.

Create a Prototype and Proof of Concept

There are many companies that specialize in helping entrepreneurs and startups with prototype design. Their services range from consulting through prototyping – here are a few notable companies operating in this space:

1. IDEO: IDEO is an international design and innovation firm known for its human-centered design approach. Their services encompass product design, prototyping and designing strategy development as well as helping entrepreneurs create prototypes that align with user needs and market requirements.

2. Proto Labs: Proto Labs is a rapid prototyping and manufacturing service provider, offering 3D printing, CNC machining, injection molding and fast turnaround times to rapidly transform designs into functional prototypes.

3. Dragon Innovation: Dragon Innovation provides hardware startups with expert design, engineering and manufacturing support services from prototype design through mass production of their product development efforts.

4. Bresslergroup: Bressler group is a design and innovation consultancy, offering startups assistance in creating innovative product concepts and translating them to functional prototypes. Their specialty lies in user-centered design; furthermore they also offer industrial design engineering as well as prototyping expertise.

5. PCH International: PCH International is a product development and supply chain management firm that works with both startups and established brands alike, offering services like prototyping, manufacturing and logistics that help bring product ideas to fruition for startups.

6. Spark Innovations: Spark Innovations is a product design and development firm, specializing in turning ideas into prototypes and manufacturing-ready designs. Their services encompass industrial design, mechanical engineering, prototyping techniques and various other disciplines of study.

7. Altitude: Altitude is a design consultancy that assists startups with product design and development. They specialize in concept ideation, prototyping and user experience design services to produce engaging prototypes with functional capabilities that enable companies to test out their ideas with.

8. TTP (The Technology Partnership): TTP is an engineering and technology development firm offering product design, prototyping and manufacturing services for medical devices, consumer electronics and industrial products. Their teams boast extensive expertise across their various areas of specialization.

These companies specialize in working with startups, providing expertise, technical skills, and resources that can assist your prototype design from conception to realization. Selecting one that best meets your needs, budget, and project requirements is paramount.

Navigating the Regulatory Landscape

Navigating the regulatory environment when starting a medical device company is critical to its success. Adherence to regulatory requirements ensures patient safety, product efficacy and market access regardless of your launch location. Here are some key points for navigating this terrain:

1. Determine Applicable Regulations: Identify all regulatory bodies and laws relevant to medical devices in your target market, such as FDA in the U.S. regulating them under Food, Drug, and Cosmetic Act or In Vitro Diagnostic Regulation (IVDR or MDR) in Europe regulating them accordingly. Knowing which laws pertain directly to your device’s success is of utmost importance for its success.

2. Classify Your Device: Medical devices can be divided into various risk categories depending on their intended use and potential risks to patients, with each category determining regulatory requirements and levels of scrutiny for market approval. By classifying your device appropriately (Class I, II or III) you can better understand regulatory pathways, conformity assessment procedures and documentation requirements applicable.

3. Establish a Regulatory Strategy: From early in product development, create an in-depth regulatory strategy plan. This should include all steps and timelines necessary for regulatory compliance such as preclinical testing, clinical studies, quality management system implementation, regulatory submissions etc. Partner with experts or consultants to make sure your plan aligns with regulatory requirements.

4. Conduct Preclinical and Clinical Studies: Depending on the risk category of your device, preclinical and clinical studies may be required to demonstrate its safety and efficacy. Preclinical testing includes lab and animal models; while human participation testing occurs during clinical studies. Data generated during these studies provides regulatory submissions with evidence of your device’s safety and performance.

5. Quality Management System (QMS): Establish and implement an ISO 13485 compliant quality management system in order to comply with processes, design controls, manufacturing, post market surveillance requirements as well as regulatory standards imposed upon your processes and their system requirements – this ensures consistency, traceability and documentation throughout product life cycles.

6. Prepare Regulatory Submissions: Gather all necessary paperwork and create regulatory submissions for market approval, such as technical files, design dossiers, labelling information, risk analyses and clinical data. Ensure your documents comply with any specific requirements set by regulatory bodies in terms of format, content and process for submissions.

7. Post-Market Surveillance: Once regulatory clearance or approval is secured, establish post-market surveillance processes to track and report adverse events; conduct clinical follow-up studies post market; as well as create a vigilance system to track device’s ongoing safety and performance monitoring.

8. Keep Current on Regulatory Developments: As regulations for medical devices can change at an ever-increasing pace, stay abreast of any updates or revisions that might impact your device by engaging with industry associations or regulatory agencies as well as attending conferences or webinars to remain aware of new developments and ensure compliance.

Navigating the regulatory environment takes careful planning, strict adherence to standards and extensive knowledge of regulations affecting medical devices in your target market. Engaging regulatory specialists or consulting experts is invaluable when it comes to meeting compliance obligations, speeding approval processes and successfully bringing medical devices or services products or services to market.

Secure Funding:

As with anything, funding options for medical device startups vary across regions. Below are a few sources in Europe, the UK, Switzerland, USA, China and India,


1. European Investment Fund (EIF): The EIF offers funding through various programs such as venture capital funds and equity investments to support innovative startups across Europe – specifically medical device industry startups.

2. Horizon Europe: This European Union program offers grants, loans and equity investments to promote research and innovation across various fields – such as healthcare and medical technology.

3. European Investment Bank (EIB): The EIB offers financing and investment support to European innovative companies such as medical device startups through venture capital funds and direct investments.

United Kingdom:

1. Innovate UK: As the UK’s innovation agency, Innovate UK provides funding opportunities to both early-stage and established medical device businesses through programs that support research, development, and commercialisation activities.

2. Crowdfunding: Crowdfunding is famous in the UK and is known to attract bigger investors in the pool of thousands of investors. Standing out here is difficult but right technology has raised millions through this platform.


1. Swiss Innovation Agency (Innosuisse):

Innosuisse provides funding and support services to startups engaged in innovative projects within Switzerland, such as medical device startups. They offer grants, coaching sessions, as well as access to their network of experts and resources.

 United States:

1. National Institutes of Health (NIH): The NIH offers grants, contracts and funding opportunities for early stage and translational medical device research projects, including funding opportunities such as Small Business Innovation Research grants (SBIR) and Technology Transfer Research programs which assist startups creating innovative medical device products.

2. Small Business Administration (SBA): The SBA offers various loan programs, such as its 7(a) loan program that provides medical device startups with funding.

Medical device startups in these regions must research each funding source carefully and understand its eligibility criteria, application processes and terms in order to gain access to funds that could help their venture thrive. From local government agencies and incubators/accelerators/grant competitions all these sources could offer funding opportunities.


1. China National Medical Products Administration (NMPA) Funds: The NMPA provides grants and funding programs designed to facilitate developing and commercializing innovative medical devices in China, with an aim of encouraging domestic innovation while improving healthcare delivery systems in China.

 2. China Healthcare Investment Funds: Numerous investment funds specializing in healthcare and medical device industries exist within China, supported by government bodies to assist startups creating cutting-edge medical technologies and devices.

 3. Chinese Venture Capital Firms: China has an expansive venture capital ecosystem, with firms specialising in healthcare and medical technology investments offering funding, strategic advice and industry connections to medical device startups looking to break into Chinese market. These venture capital firms can be vital allies when venturing into new markets – be it medical device sales or distribution contracts in China.

 4. State and Local Government Programs: China has implemented funding programs designed to bolster local startups and foster innovation, including grants, subsidies and other forms of financial incentive to medical device companies located within their borders.

5. Partnerships With Chinese Companies: Medical device startups seeking funding and resources may benefit from entering strategic partnerships with established Chinese medical device manufacturers. Such relationships could take the form of licensing agreements, joint ventures or co-development initiatives that enable startups to capitalize on expertise provided by partners as well as distribution networks provided by partners.

It is crucial to recognize that successfully navigating China’s funding landscape requires local expertise and in-depth knowledge of market dynamics and regulations in China. Partnering with advisors, incubators or accelerators that specialize in healthcare funding opportunities could prove helpful in providing guidance.

China is an attractive location for medical device startups to find funding and expansion opportunities due to its expanding healthcare market and emphasis on innovation. To be successful at finding financing in this market, however, extensive research, due diligence and knowledge of local regulations must be performed prior to considering funding opportunities in China..

India provides various funding resources and programs to medical device startups. Here are a few:

1. Biotechnology Industry Research Assistance Council (BIRAC): As a government organization, BIRAC offers various funding schemes for innovative projects within biotechnology and healthcare. Startups creating medical devices may want to consider applying for grants such as the Biotechnology Ignition Grant (BIG), Biotechnology Industry Partnership Programme (BIPP), or Small Business Innovation Research Initiative (SBIRI).

2. Department of Science and Technology (DST)-Technology Development Board (TDB): The DST-TDB provides financial assistance through grants and soft loans for technology development and commercialisation, with medical device startups eligible for funding under either its Technology Development and Utilization Programme (TDUP) or Seed Support System (SSS).

3. Startup India: The Startup India initiative from the Government of India provides numerous benefits and support mechanisms for startups operating within medical device sector, including medical device companies. Startups may gain access to Fund of Funds for Startups (FFS) schemes, tax exemptions, and ease of regulatory compliance.

4. Incubators and Accelerators: India boasts an increasing number of healthcare and medical technology incubators and accelerators that offer funding, mentorship, networking opportunities, access to infrastructure resources as well as funding – such as T-Hub, Centre for Innovation Incubation and Entrepreneurship (CIIE), Atal Incubation Centers (AICs).

5. Venture Capital and Angel Investors: India boasts an active venture capital and angel investor community which invests heavily in healthcare technology startups. Engaging with these investors can provide access to funding as well as the industry expertise essential to growing medical device companies.

6. Public Sector Undertakings (PSUs): Indian public-sector PSUs can collaborate with startups to provide funding for innovative projects. Medical device startups could find partners such as Bharat Heavy Electricals Limited (BHEL), Indian Oil Corporation Limited (IOCL), or Hindustan Petroleum Corporation Limited (HPCL).

Medical device startups looking for funding opportunities in India’s diverse healthcare ecosystem must carefully research eligibility criteria, application processes and terms associated with each funding source or program before exploring possible avenues. Engaging with startup competitions, pitch events or networking forums could also open doors to investors that could open funding doors in this market.

Common sources:

Venture capitalists (VCs) and angel investors play key roles in funding startups and driving innovation across various industries – including medical device.

Venture capitalists (VCs) are professional investors that typically employ institutional funds in high-growth startups through venture capital firms. Operating through venture capital firms, VCs provide capital in exchange for equity or ownership stakes in startups in exchange for significant funding investments.

Before making their decisions on investments, venture capitalists conduct extensive due diligence analyses of market potential, growth potential assessment and potential risks of the startups they plan to invest in, to make informed investment decisions. Furthermore, venture capitalists offer strategic guidance, mentorship services, industry connections as well as access to their network which all help drive medical device startups forward!

Angel investors, on the other hand, are typically wealthy individuals who make early-stage startup investments. In contrast to venture capitalists, angel investors tend to be more flexible with their criteria and can provide funds at any point throughout a startup’s journey.

Angels tend to take higher risks by supporting promising ideas with passionate founders while providing financial support as well as mentorship and industry insights from previous endeavours. Angel investors play an essential role in kickstarting medical device startups and helping them gain traction in their respective markets.

Venture capitalists and angel investors offer medical device startups invaluable sources of funding and support, with venture capitalists being an especially invaluable source. Leveraging them can give startups access to capital, expertise, industry connections and guidance that helps navigate competitive landscapes, accelerate growth and secure long-term success.

Entrepreneurs must understand the differences in investment criteria for both types of investors in order to approach those most suitable for their startup’s stage of development and funding requirements.

Contact our expert team of consultants today and see how they can assist with specific support groups and agencies that offer funding solutions.

Adopt Continuous Learning and Innovation:

AI-Based Products: One of the primary concerns among startups today is creating trustful data sets for AI-powered products; numerous firms specialize in this process and can assist you with adding this capability into medical devices. Below are a few noteworthy firms:

1. IBM Watson Health: IBM Watson Health is a division of IBM that specializes in using AI and data analytics for healthcare purposes, offering solutions such as image analysis, genomic research, drug discovery processes and clinical decision support systems.

2. Google Health: Google Health employs AI technologies to develop innovative healthcare solutions, undertaking projects such as AI-powered diagnostic algorithms, natural language processing for medical records and predictive analytics for disease management.

3. Microsoft Healthcare: Microsoft Healthcare’s mission is to revolutionize healthcare with AI solutions. They offer tools, platforms, and services which enable developers to build and deploy AI applications within healthcare – as well as cloud infrastructure to speed deployment of these apps.

4. Arterys: Arterys offers AI-powered medical imaging solutions. Employing deep learning algorithms to analyze medical images and assist radiologists with diagnosing various conditions, Arterys’ platform enables faster and more accurate image analysis to facilitate early detection and treatment planning.

5. Aidoc: Aidoc is an AI-powered radiology solution provider. Their algorithms scan medical images quickly and efficiently to quickly recognize critical findings, helping radiologists streamline workflow while improving diagnostic accuracy.

6. BenevolentAI: It is an innovative artificial intelligence (AI) company that combines AI with scientific research in order to accelerate drug discovery and development. They utilize machine learning and data analytics tools in order to rapidly identify potential drug candidates and optimise treatment strategies quickly; providing services in oncology, neurology and rare disease areas among others.

7. Sensyne Health: Sensyne Health specialises in applying AI and clinical data analysis to advance patient care and medical research. They collaborate with healthcare providers and research organizations to design AI-powered solutions that enhance disease detection, patient monitoring, treatment outcomes and treatment success rates.

8. Imperial College London’s Faculty of Medicine conducts cutting-edge AI research for healthcare, working closely with industry partners and startups on AI technologies and algorithms that enhance diagnostics, drug discovery and personalized medicine.

9. Cambridge Medical Robotics: Cambridge Medical Robotics specialises in designing robotic systems for minimally invasive surgical procedures using cutting edge AI and machine learning technology to increase surgical precision, improve patient outcomes and accelerate recovery times.

10. PrecisionLife: PrecisionLife uses AI and machine learning techniques to analyze complex datasets and uncover unique insights for personalized medicine projects such as disease stratification, drug target identification and optimizing treatment strategies.

Before selecting an artificial intelligence (AI) development company, it’s crucial to assess their expertise, track record and experience within healthcare. Take into account their capacity for compliance with data privacy and regulatory issues as well as understanding of medical device manufacturing challenges. Partnering with an established AI firm will enable you to leverage cutting-edge technology while hasten development of your medical AI device.

Software-Based Products –

There are many solutions providers for IT support where  companies assist in the creation or development of software-based products or applications for yous, so as to guarantee optimal outcomes we suggest working with one or more of our recommended partners:

1. Blum Health’s Blum Connect offers an all-in-one solution for clinical application software development teams’ software development needs. Build or have your team build code and rules themselves.

2. Light-it offers comprehensive software development and security services from start to finish, while Google Health pioneered healthcare innovation with end-to-end solutions, cloud computing services, and security services.

3. Microsoft Healthcare – Provides premier healthcare solutions for developers through their cloud platform and custom software designs.

Contract Manufacturing Services for Healthcare Products: Numerous contract manufacturing services specialize in healthcare product production at scale. Such firms possess the expertise and infrastructure required for producing medical devices, pharmaceuticals and other items related to healthcare on an industrial scale – countries like UK, India, China have invested significantly in this area while DIT of these countries’ large-scale healthcare product production works closely with startups operating within this space.

Product Liability Insurance for Medical devices

Product Liability Insurance for Medical devices

Medical devices are subject to product defects. These product defects arise due to design, manufacturing or even a failed instruction for use of a product.

These defects can cause risks to patients, who in turn can sue the manufacturer for the damages caused. As medical device manufacturers, it is imperative to choose insurance that best covers themselves as well as their affiliates.

Product liability was brought in place to ensure that potentially unsafe products are discouraged from being placed in the market and manufacturers are held responsible for patient safety.

  • Design defect: The product design does not meet the required general safety standards and performance requirements. Design defects can be identified with the help of testing standards. (Insert link for testing standards around the world post here)
  • Manufacturing defect: Deviation from the standards set by the manufacturer during the manufacturing stage. Manufacturing defects can be minimized by having apt quality assurance and quality control measures.
  • Instruction defect: Unclear explanation of how to use the product and the associated risks due to misuse of a product.

Economic Operator Obligations for Product Liability

As medical device manufacturers, numerous obligations have to be followed. These obligations are specified in Article 10 of EU MDR 2017/745, and that of Authorized representative and importer is mentioned in Articles 11 and 13, respectively. 

All these economic operators are liable for product damages. Point 16 of Manufacturer obligations (Article 10 of EU MDR 2017/745) explicitly mentions the requirement for insurance based on the risk class, type of device and size of the enterprise. The exact requirement also applies to Authorized Representatives (Point 5 Article 11). To understand all the other responsibilities of a medical device manufacturer, please read our article on manufacturer obligations .


Who is liable for product defects?

The liability claim is usually brought against the manufacturing company. Along with the manufacturer, the authorized representative and the importer is also fined for any damages. To mitigate costs, it is necessary to choose an insurance that cover the maximum payable amount. This insurance must also cover for the affiliates as they are also liable for damages.

Why is insurance important?

Medical device manufacturers must have insurance in place to reduce the overall financial burden that a product defect may cause. The insurance cover depends on the level of risk a medical device may pose to the patient. For example, an implantable device like a pacemaker may cause a higher risk to the patient and therefore the insurance should cover for a higher amount. Whereas a device like surgical gauze does not require insurance that covers a huge amount.

How do I find out the insurance that best suits the company’s requirements?

In practice, the damages are primarily meant to compensate for any suffering caused. Manufacturers, therefore, need to evaluate certain aspects before choosing the best plan for the organisation. The value for compensation must be determined by:
·         The severity of the injuries (intensity of the pain, recovery time, etc.)
·         Consequential damage
·         Impairment of one’s personal or professional life
·         The injured person’s age
·         Level of culpability (degree of culpability, possible contributory negligence)
·         The financial status of the parties concerned (income, assets)

Testing Standard Requirements around the World

Testing Standard Requirements around the World

Medical device testing standard- an overview

Medical device testing is a crucial step in manufacturing a product. This mandatory process ensures that the medical device is safe and effective. Testing of medical devices proves that the product complies with the standards and regulations of a country.

Moreover, it also sheds light on any product defects. This article discusses the testing requirements and the applicable standards.

Medical device testing applies to all medical devices, in-vitro diagnostic devices, combinational products, and active implantable devices. Some common testing of medical devices is given below:

  • Electrical safety tests
  • Functional safety tests
  • Performance tests
  • Electromagnetic compatibility (EMC) tests
  • Electromagnetic Interference (EMI) tests
  • Immunity Tests
  • Biocompatibility tests
  • Chemical testing
  • Cybersecurity tests (applicable to SaMDs or software that store data)
  • Storage and Transport
  • Ingress Protection

Medical device testing is crucial as the device intended for patient use must be safe. The tests a medical device must undergo depend on the device’s type. To explain further, medical equipment like a ventilator must undergo an electrical safety test.

At the same time, a device such as a cannula requires appropriate biocompatibility tests. Hence, the choice for a practical device test is taken with the help of the medical device’s intended use.

The testing procedure should be logical and must begin with a risk analysis. After identifying the failure mechanisms and hazards associated with a device, testing strategies and processes can be devised to quantify the size of these risks.

As a result, the purpose of a test method and procedure is to offer evidence that the hazards connected with a device are insignificant or, at the very least, acceptable when weighed against the benefits received from its use.

Types of medical device testing

Medical device testing is broadly categorized into physical, chemical/biological and cybersecurity testing. Physical testing involves the tests such as electrical testing, MRI safety, functional safety tests and EMC tests.

IEC 60601 series is a widely accepted technical standard for the safety and performance of electrical equipment. EMC/EMI tests ensure that the overall device is compatible with other medical devices and works optimally in the device environment when subjected to interference and immunity.

Conformance to this standard provides that medical equipment does not create electromagnetic fields that could impair the operation of other devices in the usual environment.

Chemical or biological testing help achieve device compatibility with the surface of the skin. Medical devices that contact skin must comply with the ISO 10993 series- Biological evaluation of medical devices.

For this, the manufacturer must consider the choice of material used compatibility between device materials and the biological tissues, cells, and body fluids. Testing methods like stress, shear testing, and ageing tests are performed so that the final product causes the least quality concerns.

Cybersecurity testing is crucial to medical devices so that risks such as unauthorised access to data and breaches are identified, and their occurrence minimised.

A common standard followed for medical device software is IEC 62304 and ISO27001. IEC 62304 standard specifies the life cycle requirements for medical device software, whereas in ISO 27001 focuses on data and information security.

It should be noted that each of the above standards is closely related to the ISO standard for risk management of medical devices (ISO 14971).

The risks associated with the medical device should be correctly identified, and appropriate tests should be done, proving that the relevant standards are met. Please read our article on global ISO requirements for a better understanding of the ISO standards. 

Testing requirements around the world

To fully comply with the regulations of each country, one must also align with the testing standards accepted within each country. ISO and IEC standards are accepted across the globe.

Compliance with these ensures that the devices can be marketed without any major difficulties. This article discusses the testing standards followed in major medical device markets.

In Europe, close to 80% of electrical and electronic standards follow the various IEC International Standards. Standards for electromedical equipment include IEC 60601 series standards for the requirements for high-frequency surgical instruments, short-wave therapy equipment and so on.

The EU from time to time releases the harmonized standards list which are the most acceptable standards for the EU compliance.

In the US, accepts certain ISO standards however there are a list of recognized consensus standards that the FDA accepts for medical devices in the US. These include ANSI, AAMI, ATSM and so on.

ANSI standards are applicable to a variety of industries like the ISO whereas AAMI testing standards are specific to medical instruments and ATSM standards are specific for materials used in medical devices.

Canada’s list of Recognized Standards for Medical Devices mentions a combination of ISO and ATSM standards. For electromedical compatibility, it accepts CSA standards.

Australia accepts the list of standards referenced in  Conformity Assessment Standard Orders (CASO) and Medical Device Standard Orders (MDSO). It is not mandatory but conformance to these standards are recommended.


Why are testing standards important?

Testing standards ensure that the medical device is fit for use not just for the patient but also for the healthcare professionals handling them. Most countries do not have stringent requirements for testing standards, but it is recommended that the devices have some form of tests done.

Why are risk management and testing standards closely linked?

Risk analysis is a crucial step in designing a medical device. Certain identified risks can be managed with a minor change in the initial stages of the manufacture and these can be identified with the help of an appropriate test.

Disclaimer: Regulations/legislations are subjected to changes from time to time and the author claims no responsibility for the accuracy of information.

Exceptional Use Medical Devices in the EU and UK

Exceptional Use Medical Devices in the EU and UK

Medical devices conforming with the medical device regulations must have a conformity marking. Medical devices that do not conform may still be placed in the market, provided they apply through the exceptional use devices pathway.

This article discusses the exceptional use requirements to be satisfied to gain access to EU and UK markets.

In the UK, the UKCA marking displays that the device conforms to UK Medical Device Regulations 2002. Without UKCA marking, the devices can only be placed in the market under certain circumstances.

Similarly, CE marking is accepted throughout the EU, which denotes that medical device conforms to the EU MDR 2017/745. This procedure may also apply to custom-made devices that have not complied with standard conformity procedures.

These devices are called special-purpose devices in the EU and are mentioned in Article 21 of EU MDR 2017/745.

Exceptional Use of devices in the UK

Medicines and Healthcare products Regulatory Agency (MHRA) regulates medical devices as per UK MDR 2002. The MHRA may authorise non-compliant devices, but this is done on a case-by-case basis.

A manufacturer may place a medical device if the following conditions are met:

  • The clinician supports the application for the treatment of the patient
  • No alternative to this medical device is available on the market
  • Justification on how the medical device can improve the patient’s health with the device

The manufacturer is responsible for placing the device on the market, but the manufacturer and clinician must fill out the Humanitarian use of device-application form and submit to [email protected] .

The application form must be submitted for each different patient. MHRA approves the case-by-case application basis and may request more information if the application details are deemed unclear.

The application form for exceptional use devices requires the following details:

  • Name and address of the manufacturer
  • Generic name of the device
  • Clinical investigation details
  • Risk analysis, hazard identification and estimation of risks
  • Name and address of the consultant
  • Patient’s medical condition details
  • Device necessity and
  • Other relevant information  

Devices for special purposes in the EU

Devices under this category do not require a CE mark. Still, they must meet the conditions mentioned in EU MDR that the device is evaluated for its safety and effectiveness by the manufacturer.

Articles 62-82 of EU MDR describe the requirements to be met by manufacturers of investigational devices.

Firstly, for investigational devices, a proper clinical investigation plan is required. Read our detailed article on Clinical investigation in the EU for more information regarding this topic.

In short, the clinical investigation has a different technical file and application form than the CE-marked medical devices.

The application form should be submitted with the following documents.

  • Clinical investigation plan
  • Investigator’s brochure
  • Name and address of the manufacturer
  • Patient information sheet
  • Detailed risk analysis and test reports
  • Informed consent document
  • Other available technical documentation

Custom-made devices

As per EU MDR, ‘custom-made devices’ means as any device specifically made in accordance with a written prescription of any person authorised by national law by virtue of that person’s professional qualifications which gives, under that person’s responsibility, specific design characteristics, and is intended for the sole use of a particular patient exclusively to meet their conditions and needs.

However, the definition does not include ‘mass produced’ devices that need to be adjusted per user requirements. UK MDR 2002 5 (1) has a similar definition for custom-made medical devices.

The provisions in Great Britain (England, Wales and Scotland) can be accessed in Guidance on Custom-made devices in GB. Medical devices like dental appliances and prosthetics all come under custom-made devices as these are designed specifically for an individual and are not mass-produced.

Custom-made devices require technical documentation following Annex II and III of EU MDR. In addition to the documents, the manufacturer or authorised representative should draw a statement containing crucial information like that the device is intended for exclusive use by a particular user and data allowing unique identification of the medical device.

An important point to remember is that custom-made devices must conform to general safety and performance requirements in Annex I of EU MDR and essential requirements in Annex I Schedule 2A of the UK MDR 2002, and the devices are not exempt from these requirements.


What devices come under custom-made devices?

Medical devices that come under Custom-made devices are specifically designed for an individual patient. Some great examples include dental crowns, fillings, elastics and retainers for dental structure or health. Other devices such as artificial eyes and maxillofacial implants like craniofacial implants, auricular, nasal implants, hearing aids and orthopaedic footwear fall into this category. The healthcare professionals must take accurate impressions of patients so that the device is a custom fit for the end-user or patient.

What is the difference between a custom-made device and an investigational device?

Investigational devices are those that are research devices that are developed that have no market equivalent. These devices are subjected to a clinical study to check product effectiveness. On the other hand, custom-made devices are not subject to clinical research but are customised according to the patient’s requirements. Both investigational devices and custom-made devices do not require CE/UKCA marking and require exceptional devices regulatory approvals to enter the respective markets.

Disclaimer: Regulations/legislations are subjected to changes from time to time and the author claims no responsibility for the accuracy of information.

Smart Wearables Regulations in the EU 

Smart Wearables Regulations in the EU 

The booming technological aspects have constantly challenged regulations established worldwide in the modern century because the regulations either inadequately govern novel technologies, or there always exists a scenario where the devices cannot be categorized within a given regulation.

Smart wearables are one of those aspects falling into such debate in recent times. Days are no longer from the fact that these smart wearables may draw strict regulations to be in place.

How are these general wellness devices regulated? What are these devices classified as?

Unlike medical devices, these devices are intended to be used for wellness reasons such as to improve the lifestyle by monitoring the user’s diet and exercise, enhancing physical activity etc., and they are ideally not intended to get involved in any diagnosis or therapy.

Intended Use

Any device is subject to a regulation based on its “intended use” declared by the manufacturer. Hence the manufacturer needs to pay utmost attention in declaring what their device supposed is to be used for real-life scenarios.

Smart wearables are often confused with medical devices, or sometimes they are by mistake considered medical devices if a vague intended use statement is written for the device.

Generally, smart wearables are low-powered electronic equipment intended to be worn by the user, such as wrist-worn, neckband, body-worn, adhesive to the skin surface to collect some data and transfer the information to a mobile device application.

Sensors and electronic components present in your smart wearables monitor your activities which could be determining the body’s orientation, climbing stairs, speed of walking or running, heartbeat, oxygen levels, respiratory rate, sleep patterns, etc.

Now the question here is, should one consider this a medical device when the device monitors HR, SpO2, and respiratory rates, which a physician usually monitors to determine the state of health and use these data to diagnose any physiological condition.

The answer is not straightforward, but there are smart wearables in the market that obtain FDA clearance that claims to perform certain medical purposes as the intended purpose. Such devices fall under the medical device category.

Hence, if the manufacturer claims that the device has a “medical purpose” in its intended use, the device falls under a medical device. Claims are critical in these cases.

How is my smart wearables regulated?

In Europe, there is no separate regulation released to date for smart wearables; however, depending on the nature of your device, it is mandatory to adhere to the applicable EU directive or EU Regulation. CE marking is mandatory for all categories of equipment entering the EU market.

It is essential to identify the applicable regulations for the device based on the nature and functionality of the equipment. For any electronic radio equipment, the following EU directives apply

· Radio Equipment Directive 2014/53/EU

· EMC Directive 2014/30/EU

· Low Voltage Directive 2014/35/EU

· RoHS and REACH Directive 2011/65/EU

· WEEE Directive 2002/92/EC

The below tables give a quick brief of key requirements applicable across the directives and this list is non-exhaustive:

SectionsRadio Equipment DirectiveEMC DirectiveLow Voltage DirectiveRoHS and REACH
Essential RequirementsArticle 3Article 6 Annex ISafety Objectives -Annex IArticle 4, Annex II Prevention
Technical DocumentationArticle 21 Annex VAnnex II or IIIAnnex IIIArticle 6 Review of Restricted Substances
Conformity AssessmentArticle 17, Annex II or III or IV  Article 14, Annex II or IIIAnnex IIINot applicable
Obligations for Economic Operators*ApplicableApplicableApplicableApplicable
EU DoCArticle 18 Annex VIArticle 15 Annex IVArticle 15, Annex IV &  Module A of Annex IIIArticle 13, Annex VI
Simplified DoCArticle 18 Annex VIINot applicableNot applicableNot applicable
Field Corrective measuresApplicableApplicableApplicableApplicable

*-Economic Operators consists of Manufactures, Authorised Representatives, Distributors and Importers

The above listed are very few directives applicable for a low-powered electronic radio equipment category of the smart wearable device. It is the manufacturer’s responsibility to identify relevant regulations suitable for the device and adopt the same to meet product compliance.

The directives and standards differ based on the type of devices, such as IT and telecommunication, digital, and audio/video radio equipment.

How to use Harmonized Standards to demonstrate compliance?

Harmonized standards are voluntary standards adopted by the EU commission and deemed acceptable to demonstrate product compliance. It is presumed that by adopting harmonized standards published by the EU commission for those directives, the manufacturer can claim product compliance to the respective directive.

The standards adopted for design and testing should comprise safety and functional performance relevant to the devices. It also must meet the essential requirements of the directives/regulations.

Accredited Laboratory Testing

Testing is an integral part of demonstrating product compliance. It is always advisable to approach an accredited third-party laboratory to perform the applicable tests for your product. Manufacturers’ internal test reports are rarely considered for compliance or sometimes a risky element to showcase such reports.

Significance of Technical Documentation

As stated above, RED, EMC and LVD directives mandate the manufacturer to maintain technical documentation of the product with a retention period of 10 years from placing the device on the market. 

Instructions for Use (IFU) and Labelling

Manufacturers are obliged to supply adequate information on the device’s safe usage and the device. The accompanied instruction and safety information must be in a language that can be easily understood by the user and be in the official languages of the member states. The safety information of device interference characteristics must be disclosed for radio equipment that intentionally emits radio waves.

Declaration of Conformity

The manufacturer must provide the DoC with each device sold in the market, and it needs to be in the official language of the member states. In cases where more than one directive or regulation is applied to the device, the contents of the DoC must include all the elements listed in each of those directives. In certain directives, a simplified DoC is also required to be mentioned in the IFU, where it states the location of the updated DoC on the manufacturer’s website.


Regulations in recent years are becoming increasingly stringent towards safety. As these devices bring in more advancements and are closely engaged with the human lifestyle to promote health and wellness, there must be careful consideration in bordering these products from being falling into the medical devices category. Eventually, be it a medical device or any equipment, it is the ultimate responsibility of the manufacturer to produce safe products.


Does the EU maintain a list of harmonized standards?

The EU Commission maintains a list of harmonized standards published on their official website, which is updated on a timely basis.

How does the EU regulate Data protection and privacy of the data?

General Data Protection Regulation applies to devices that collect and process the users’ personal data. European Union has sought to ensure the protection of this right through legislation. The vital regulatory principles of this GDPR are data protection principles, accountability, Data security, Data protection by design, consent, and people’s privacy rights.

Does US FDA have any regulation on smart wearable technologies?

FDA does not regulate general wellness devices, but it has released general guidance on the “general wellness: policy for low-risk devices” to provide clarity to industry and FDA staff on the Center for Devices and Radiological Health’s (CDRH’s) compliance policy for low-risk products that promote a healthy lifestyle.

Disclaimer: Regulations/legislations are subjected to changes from time to time and the author claims no responsibility for the accuracy of information.

Global Labelling Requirements

Global Labelling Requirements

Label, Labelling vs Instructions for Use (IFU)?

  • A Label is the written, printed, or graphic information that goes on the packaging of the medical device.
  • Instructions For Use (IFUs) or Package Insert is the essential information accompanying the medical device for its safe and effective use by the user. It can be a single to multiple-page document.
  • Labelling is the content that goes on the Label or IFUs.

What are the minimum requirements for labeling?

The ISO has published many standards applicable to the medical device industry. Some of them are as below:

Standard NumberStandard Name
ISO 18113  In vitro diagnostic medical devices – Information supplied by the manufacturer (labelling) – Part 1, 2, 3, 4 and 5
ISO 28219Packaging – Labelling and direct product marking with linear bar code and two-dimensional symbols
ISO 15223  Medical Devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1 and 2
ISO 3864  Graphical symbols – Safety colours and safety signs – Part 1, 2, 3
ISO 20417Medical devices – Information to be supplied by the manufacturer
ISO 14025Environmental labels and declarations – Type III environmental declarations – Principles and procedures
ISO 14021Environmental labels and declarations – Self-declared environmental claims (Type II environmental labelling)
ISO 14020Environmental labels and declarations – General principles
ISO 22742Packaging – Linear barcode and two-dimensional symbols for product packaging
There are more specific product-oriented labelling standards available.

ISO 20417 has defines information to be disclosed by the manufacturer. Every medical device manufacturer, distributor, importer, or Authorized Representative is bound to comply with the standard before placing the device on market. The requirements are as follows:

Information on Label

  • Manufacturer details – Trade Name, address, country
  • Product description.
  • Product identification – model or catalogue number, Lot number, serial number, expiry date, UDI,
  • Storage instructions
  • Operating instructions
  • Warning or precautions
  • Presence of any harmful substances (>0.1% w/w), biological origin substances, medicinal substances, nanotechnology materials
  • Electronic IFUs (if available)
  • Mention of: Single-use/ Single patient multiple-use / Reuse / Limitation on reuse
  • If Sterile and method of sterilization
  • Explanation of safety-related colours

Information on Packaging

  • Name and address of the manufacturer or an authorized representative
  • UDI
  • Production controls – lot number, serial number, expiry date
  • Model number, catalog number, commercial name
  • Mention of: Single-use/ Single patient multiple-use / Reuse / Limitation on reuse
  • Storage or special handling requirements
  • Any special requirements for battery-powered medical device
  • Contraindications, warnings, or precautions

Information in IFUs

  • General information (as above)
  • Intended Use of the medical device
  • Safety information
  • Performance of the medical device
  • Any residual risk associated with the use of the medical device or its accessory
  • Any known contraindications
  • Document control number of the IFU
  • Safe disposal information
  • Any specific instructions for handling or preparatory treatment
  • Any warnings, precautions, or limitations
  • If any accessories or indicators are provided along with the device, instructions on their use to be provided in the IFU.
  • Technical description

The harmonized ISO standard makes sure true and uniform information is conveyed to a lay/common person.

Global Labelling Requirements

Most countries have a mandatory requirement for the IFUs or Labels in their local language. To streamline this requirement, ISO 15223 standard provides a list of signs and symbols that depict common terms such as Manufacturer, Lot number, storage conditions, Expiry, eIFU and many more.

The uniform symbols help in identifying the necessary information without the language barrier. Another advantage is it saves significant label space.


Is it necessary to follow the ISO standards?

It is advisable to develop a medical device in compliance with the applicable harmonized standards. This shall favor in smooth marketing of the product along with its competitors.

Is it necessary to brief the symbols in IFU when symbols from standards are used?

Yes, it is required to brief every symbol in the IFU that is used on the label of the product.

Can a distributor or an importer label be affixed separately apart from the main label?

Yes, it is also allowed to affix these labels separately on the product. This is because one manufacturer may have several distributors or importers within EEA.

Is it necessary to create dedicated labels for accessories of medical devices?

Yes, it is. Not every time the accessory is shipped along with the medical device and it is required to identify them with appropriate labels.

If the manufacturer wants to provide an eIFU how to indicate this on the label?

Firstly, not all the medical devices are eligible for eIFU provision. Regulation 207/2012 states what are the categories of MDs that are eligible for eIFU.

What is the deadline to implement UDI carrier on device labelling?

Article 123.3.f states these timelines as:

Disclaimer: Regulations/legislations are subjected to changes from time to time and the author claims no responsibility for the accuracy of information.