Switzerland is a premier destination for medical device manufacturers relying on sophisticated micromanufacturing or advanced precision techniques. This appeal is evident in Switzerland’s choice of EMEA headquarters for industry leaders.
The country boasts one of the world’s highest proportions of GDP derived from the manufacturing sector, driven by traditional watchmaking, MEMS, and Medtech industries. These sectors have cultivated highly industrialized, digitized precision clusters ideal for crafting precise medical and orthotic devices.
The primary drivers compelling medical device manufacturers to opt for Switzerland include a technically adept workforce groomed by the country’s dual education system, ensuring proficiency in operating complex machinery.
Moreover, the attraction lies in Switzerland’s pragmatic, industry-tailored regulatory environment and an appealing tax system catering to foreign companies.
Medical Device Manufacturers – Pioneering Regulations, Efficiency, and Innovation
Many view Switzerland’s vocational training and close collaboration with research institutions and universities as facilitating quicker product validation and market entry.
While cost is often a reason for considering manufacturing or R&D elsewhere, numerous U.S. executives in Switzerland argue that the advantages surpass any increased expenses. Their skilled labour force proficiently handles advanced machinery, leading to fewer errors and ultimately lower costs.
Being near public authorities is advantageous, as these specialized hubs are usually geographically reachable. However, the ease of interaction with these authorities and an appealing tax system benefiting Switzerland as a European base further contributes to its attractiveness.
Testing, Scaling, and Collaboration
Switzerland offers an ideal setting for testing and expanding your business. Whether you’re experimenting with a new device or concept or engaged in the R&D phase, companies can swiftly progress from concept validation to commercialization due to an efficient bureaucracy and a tendency to avoid the usual bureaucratic obstacles in other nations.
Collaborating with Swiss corporations, startups, universities, and research institutions aids companies in extending and adjusting their businesses beyond U.S. borders, benefiting both sides.
Moreover, scaling becomes more manageable—obtaining permits and planning for new facilities is expedited and simplified.
In the intricate landscape of medical device regulations, successfully bringing products to market requires a thorough understanding of the varying requirements in different regions.
This market access guide provides comprehensive insights into the European Union (EU), Switzerland, and the United Kingdom (UK) regulations, shedding light on crucial aspects such as Authorized Representatives, Importers, and other economic operators.
Crafting your Marketing Strategy
A well-defined marketing strategy is the foundation for entering any market. It is essential to carefully consider the products you wish to sell and the targeted regions. While the instinct might be to reach every corner, strategic planning helps avoid unnecessary costs.
Post-Brexit, the complexity has increased, necessitating separate Authorized Representatives and Importers for each region.
Understanding Economic Operators
In the EU, a manufacturer outside the region must appoint an Authorized Representative.
The Authorized Representative, prominently identified on product labels, shoulders responsibilities such as verifying EU conformity, registration obligations, and cooperation with competent authorities.
EU MDR Article 11: Key Responsibilities of Authorized Representatives
Verify the EU declaration of conformity and technical documentation.
Keep copies of technical documentation and the EU declaration of conformity.
Comply with registration obligations.
Provide information to demonstrate device conformity.
Forward requests from competent authorities to the manufacturer.
Cooperate on preventive or corrective actions.
Immediately inform the manufacturer about complaints and suspected incidents.
Terminate the mandate if the manufacturer acts contrary to obligations.
Importers situated within the EU play a pivotal role in ensuring products’ adherence to regulations before entering the market. They verify CE marking, proper labelling, and other compliance criteria.
Significantly, they are obliged to keep meticulous records and promptly address non-compliance concerns.
EU MDR Article 13: Duties of Importers
Place on the market only devices in conformity with the regulation.
Verify CE marking, EU declaration of conformity, and manufacturer’s identification.
Ensure proper labeling and instructions for use.
Verify UDI assignment by the manufacturer.
Maintain a register of complaints, non-conforming devices, recalls, and withdrawals.
Cooperate with authorities on corrective actions.
Inform the manufacturer and authorities about non-compliance and serious risks.
The European Market
EU MDR 2017/745 and IVDR 2017/746
For medical devices and in-vitro diagnostics, compliance with EU MDR and IVDR is paramount. Manufacturers must meticulously follow the regulatory requirements outlined in these legislations.
Initiating with Article 10 and ensuring conformity with EU standards is the cornerstone.
EU MDR Article 10: General Obligations of Manufacturers
Verify compliance with legislation, specifically EU MDR or IVDR Article 10.
Comply with the requirements of EU MDR or IVDR Article 10 for economic operators.
Provide necessary information to authorized representatives and importers.
The EU Authorized Representative must be well-versed in EU MDR and IVDR requirements. The role encompasses tasks from verifying documentation to cooperating with authorities.
Transparency is critical, with the Authorized Representative’s details prominently displayed on product labels.
Importers act as the last line of defence before products hit the market. As per Article 13, their verification processes ensure that only compliant devices enter the EU.
The importer’s role includes handling complaints, cooperating with competent authorities, and maintaining a comprehensive register.
EUDAMED, the European Database for Medical Devices, plays a pivotal role in the regulatory landscape. Manufacturers, Authorized Representatives, Importers, and other entities must register in EUDAMED to obtain the Single Registration Number (SRN).
This digital hub facilitates information exchange, ensuring transparency and traceability.
EUDAMED Registration Process
EUDAMED, the European Database for Medical Devices, is pivotal for transparent information exchange among stakeholders. The registration process involves:
1. Identify your Role
Determine if you’re a Manufacturer, Authorized Representative, or Importer, each with unique responsibilities.
2. Access EUDAMED
Create an account on the user-friendly EUDAMED platform
3. Provide Details
Enter essential company information and specify your role.
Undergo a verification process to confirm the legitimacy
5. Get SRN
Receive a Single Registration Number (SRN) upon successful verification.
6. Maintain Compliance
Regularly update the information to stay compliant.
7. Information Exchange
Utilize EUDAMED for efficient information exchange with authorities and stakeholders. This streamlined process ensures regulatory compliance and facilitates seamless interaction within the EU’s medical device landscape.
Switzerland, no longer part of the Mutual Recognition Agreement, mandates manufacturers outside the EU to appoint Authorized Representatives and Importers within Switzerland. The regulations mirror EU MDR and IVDR, emphasizing compliance.
Differences in Switzerland
While Switzerland aligns closely with EU regulations, distinctions exist. The CH-REP symbol stands in for the EC REP symbol, and a unique registration process, distinct from EUDAMED, adds a layer of complexity.
UK Market Access: Navigating the Post-Brexit Scenario
The UK Responsible Person
Post-Brexit, the UK Responsible Person assumes a role akin to the EU Authorized Representative. The UK MDR 2002 sets out responsibilities, emphasizing conformity checks, complaint management, and immediate reporting of non-compliance.
UK MDR 2002 Responsibilities of the UK Responsible Person
Ensure the declaration of conformity and technical documentation are in order.
Keep copies of technical documentation and the declaration of conformity.
Provide information to demonstrate device conformity to the MHRA.
Cooperate with the MHRA on preventive or corrective actions.
Immediately inform the manufacturer about complaints and suspected incidents.
Terminate the legal relationship if the manufacturer acts contrary to obligations.
Unlike the EU, the UK lacks a designated symbol for the Responsible Person. The absence prompts a textual mention on labels. Notably, this requirement applies to UKCA-marked products post-Brexit.
Navigating the regulatory landscape for medical devices demands a nuanced understanding of region-specific requirements.
From strategic marketing planning to compliance with EU, Swiss, and UK regulations, this guide provides a detailed roadmap for manufacturers aiming to ensure seamless market access while embracing the intricacies of post-Brexit realities.
EUDAMED is a pivotal component, serving as the digital nexus for regulatory information exchange, ensuring compliance and traceability.
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
Electromagnetic compatibility (EMC) tests
Electromagnetic Interference (EMI) tests
Cybersecurity tests (applicable to SaMDs or software that store data)
Storage and Transport
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.
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.
ISO – International Organization for Standardization, is the international, non-governmental body for drafting and establishing technical and non-technical standards.
These standards are developed by different committees within the International Organization for Standardization. Having around 165 member states, with one representative from each, International Organization for Standardization is a global entity catering to the needs of industry requirements.
Are ISO standards important?
The International Organization for Standardization medical device standards are the Bible for many countries, especially ones which do not have predefined regulations or processes.
In addition to general standards, ISO also publishes product-specific guidance such as for Implants, Orthopedic, Medical Electric Equipment, and many more.
Global International Organization for Standardization Requirements
In Europe, the European Commission has the Medical Device Regulation MDR 2017/745 and In-vitro Diagnostic Device Regulation IVDR 2017/746.
These regulations provide a detailed framework for introducing a medical device in the European market. However, in addition to that, certain International Organization for Standardization may also be referred to for ensuring a better-quality product.
Some of the many popularly used standards include:
ISO 14971:2019 Medical Devices – Application of Risk Management to medical devices
ISO 15223-1:2021 Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements
IEC 60601-2-83 Medical electrical equipment – Part 2-83: Particular requirements for the basic safety and essential performance of home light therapy equipment
IEC 60601-1 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
The European Commission also has Harmonized Standards, developed by European Standards Organization CEN, CENELEC, or ETSI, per the international standards.
In the USA, the US Food and Drug Administration (FDA) has a Code of Federal Regulations (CFR) and Guidance.
CFRs are legally binding. Manufacturers must comply with the requirements of CFR
The guidance provides Agency’s thinking on regulatory issues. They are NOT legally binding
In addition to these, the FDA also accepts certain recognized consensus standards from different organizations such as International Organization for Standardization, CLSI, ANSI, IEC, CEN, etc.
These standards may be used to justify a Declaration of Conformity for a product. The widely accepted medical device International Organization for Standardization are, but are not limited to:
ISO 10993 – Biological Evaluation for Medical Devices
ISO 14160 – Sterilization of Healthcare Products
ISO 11737 – Sterilization of Medical Devices
In Canada, the Standards Council of Canada (SCC) is the International Organization for Standardization member body. Similar to the US FDA, the Therapeutic Products Directorate (TPD) of Health Canada periodically releases a list of acceptable international or national standards for medical devices.
Manufacturers can use these recognized standards in conjunction with the Health Canada’s Medical Devices Regulations (SOR-98/282) and the Guidance Documents, to prove product conformity and safe use in the market.
China‘s National Medical Products Administration (NMPA) is developing indigenous standards that more closely align with those of ISO. Biocompatibility testing is one avenue where the scope and requirements for China are more than that of the US/EU.
Hence, NMPA has developed various biocompatibility testing standards which are to be used in addition to the International Organization for Standardization standard.
For the rest of the world’s medical device industry,
India encourages International Organization for Standardization certification for all its industries. The medical sector must be International Organization for Standardization 13485 compliant while the pharmaceutical sector must be ISO 9001 compliant for Quality Management Systems, in addition to other relevant and applicable International Organization for Standardization.
Japan’s The Japanese Industrial Standards Committee (JISC) is an International Organization for Standardization member body. The regulatory authority, Pharmaceutical and Medical Device Agency (PMDA) revised its Ordinance No. 169 in 2021 to closely align with the International Organization for Standardization 13485:2016 standard. The transition period is 3 years and must comply by March 25, 2024
For the Korean regulatory authority, aligning the requirements of Korean Good Manufacturing Practice (GMP) to that of International Organization for Standardization 13485:2016 is believed to be a step closer to entering the Medical Device Single Audit Program (MDSAP)
Russia’s Federal Service for Surveillance in Healthcare (Roszdravnadzor) is known to accept International Organization for Standardization 13485:2016 certification. Information on acceptance of other International Organization for Standardization cannot be confirmed. It does not accept market approvals in the US, EU, or other countries as a reference for market authorization in Russia
Australia’s Standard Australia is a member of the International Organization for Standardization, IEC, and ICSID. It strongly encourages the use of international standards, except where their use is ineffective or inappropriate and does not develop any national Australian standard for which there is already an international standard in existence. In 2019, TGA published Therapeutic Goods (Conformity Assessment Standard for Quality Management Systems) Order 2019which provides a list of applicable conformity assessment standards.
Brazil’s ANVISA accepts Good Manufacturing Practices (GMP) along with the International Organization for Standardization 13485
Can QMS be established solely based on ISO standards?
For countries that do not have their own QMS regulations, the ISO standard can be used as a reference. For countries with established local regulations, and that accepts ISO, both ISO standard and local/national regulations must be considered.
Are ISO standards freely available?
No. ISO standards are available for purchase from the ISO official website. However, they do have FREE read-only formats available.
Comparing ISO standards to local regulations, which one takes precedence?
The local or national regulation always takes precedence over the ISO standard.
Can the manufacturer use an older version of an ISO standard for compliance?
No. Manufacturers must make sure they comply with the active or most recent version of the ISO standard. This is not restricted just to ISO standards but applies to National regulations too. Manufacturers must keep their QMS up to date with the latest requirements of the industry. The ideal way to be updated is to refer to the latest version of any Standard or Regulation.
Disclaimer: Regulations/legislations are subjected to changes from time to time and the author claims no responsibility for the accuracy of information.
The EU MDR 2017/745 imposes more stringent requirements for Class I devices. Under the new regulations, Manufacturers must righty classify a medical device and provide technical documentation following the device class.
The risk class under MDD could change under MDR. In some cases, medical devices could be up classified from Class I medical devices to Class II a/b medical devices or Class III medical devices.
Step 1: Integrate MDR into the existing Quality Management System.
This allows the correct documentation to be created following the risk classification of the device.
Step 2: Confirm whether the product is a medical device under the scope of MDR.
Confirm that the product meets the definition of a medical device as stated in Article 2 of EU MDR based on its intended use and primary mode of action. In some cases, the product may be out of the scope of MDR and may be termed as a medical device ‘accessory ’. EU MDR also states how accessories for a medical device is also to be classified on its own apart from the main medical device.
Step 3: Confirm whether the medical device is a Class I medical devices.
It must be noted that several MDD Class I medical devices will be reclassified under the MDR as per the new classification criteria in Annex VIII, such as most software (rule11) and Class I medical devices made up of chemicals or combinations of substances (rule 21).
Step 4: Pre-market procedures.
Verify that the device meets the General Safety and Performance Requirements (GSPR).
A proper and well-established risk management system should be implemented. Manufacturers must ensure that the associated risks are identified, analysed and appropriate corrective actions are taken.
This must be guaranteed throughout the product’s lifecycle and documented. When standard specifications are available, Manufacturers must adhere to them unless they can demonstrate that they have adopted a solution that is at least as safe and effective.
The Manufacturer should periodically update the clinical evaluation report, risk management and post-market reports.
Conduct Clinical evaluations
All devices require clinical evaluation, Class I medical devices are not exempted from this requirement. A clinical evaluation report must contain essential information such as device descriptions, literature reports and post-market surveillance reports to name a few.
MDR also emphasises the need to consider available alternatives and the acceptability of the benefit-risk ratio.
Prepare an up-to-date technical file.
The Manufacturer will draw up the technical documentation that demonstrates the conformity of their devices with the specific requirements of the MDR. Technical documentation is mentioned in Annex II and III of EU MDR.
The Manufacturer is obligated to keep the file updated and make them available to competent authorities, notified bodies and the authorised representative.
The technical file must contain the following elements. The detailed information can be found in Annex II of EU MDR.
Device description and specification, variants, and accessories
Information to be supplied by the Manufacturer
Information on Design and manufacturing
General Safety and Performance Requirements
Verification and validation of product
Demonstration of Conformity
The documents in the technical file should be made available in the language accepted in the Member State in which the device is sold. Please read our article on EU Requirements for translations to understand this requirement specified in EU MDR.
Involvement of Notified Bodies
Most Class I devices do not require the involvement of a Notified Body. However, device Classes ‘Ir’, ‘Is’ and ‘Im’ have this requirement. ‘Ir’ devices are those which are reusable instruments. ‘Is’ are devices to be used in a sterile condition. ‘Im’ are those devices with a measuring function.
For these class I medical devices, the involvement of Notified Bodies is limited to audit and the NB assesses those specific controls. For example, an “Is” device assessment of NB would involve auditing the Sterilisation process and controls.
Prepare Instructions for Use and Labelling
Medical device manufacturers must ensure that the instructions for use and labels are available in languages accepted within the Member State they decide to market in.
The instruction for use must indicate the safety and performance information so that its users are aware of its intended use. The instructions for use (IFUs) should have drawings and internationally accepted symbols.
The Declaration of conformity (DoC) is a document signed by the Manufacturer that states the device fulfils the requirements set forth by MDR. For more information, read our article on Declaration of conformity.
Step 6: Affix CE mark.
CE mark should be placed on the medical device to show compliance. If it cannot be placed on the product itself, it must be placed on the packaging.
Before placing in the EU market, all devices must be registered on EUDAMED. EUDAMED is a secure, web-based European Databank on Medical Devices. Although Class I devices are not much of a threat to human life, they must be made available on EUDAMED. It ensures that the device information is accessible to the public.
Transitional provisions for Class I Medical Devices
Transitional provisions are in place to help manufacturers transition to MDR from the directives. Article 120 of EU MDR gives an idea of the exemptions from MDR and greatly helps manufacturers by providing more time to meet the requirements.
The following conditions must be met to be able to market a device according to Directive 93/42/EEC until 26 May 2024:
The device complies with Directive 93/42/EEC.
The device has not undergone significant changes in device design or intended purpose.
The device has a valid Declaration of Conformity (DoC)
The post-market surveillance, Market Surveillance, Vigilance and Registration of economic operators and devices requirements are met.
Does a Class I Device manufacturer require an ISO certificate for the Quality Management System?
Not necessarily. The Class I manufacturer must have an established QMS, and obtaining a certification is not mandated. Although globally, there is a significant benefit for the Manufacturer to hold an ISO QMS certification. Major markets worldwide accept ISO 13485 certificate as one of the key entry factors into their geography. A few key markets, such as Canada, Japan, Australia, Singapore, and Malaysia, require ISO Certification. The ISO 13485 certificate is recognised worldwide as a significant standard for a quality management system for medical device manufacturers.
Should Class I Device DoC contain the reference to MDR Annex (s)?
Yes, but this has been considered of less importance while drafting the DoC. Declaration of Conformity (DoC) must mention the respective Annex(s) in the MDR that it has complied with for any device class. This is one of the required information to be entered while performing product registrations in many countries.
What is the conformity procedure for Class I devices?
The conformity procedure for all Class I devices is mentioned in the flow chart.
SaMD is software intended for one or more medical purposes that perform these without being part of a hardware medical device.
Medical device software is meant to be used, alone or in combination, for a purpose specified in the definition of a “medical device” in the MDR or IVDR, regardless of whether the software is independent or driving or influencing the use of a device.
To be qualified as medical device software, the product must first fulfil the software definition according to this guidance and the description of a medical device according to Article 2(1) of Regulation (EU) 2017/745 – MDR.
To be qualified as an in vitro diagnostic medical device software, the product must additionally fulfil the definition of an in vitro diagnostic medical device according to Article 2(2) of Regulation (EU) 2017/746 – IVDR.
Decision steps for qualification of software as MDSW
Decision step 1: If the product is software according to Section 2 of the guidance (link provided at the bottom), then it may be a medical device software; proceed to decision step 2; else, it is not covered by this guidance but may still be covered by the Medical Devices Regulations.
Decision step 2: If the product is an MDR Annex XVI device or an accessory for a medical device, or is software driving or influencing the use of a medical device, then it must be considered as part of that device in its regulatory process or independently if it is an accessory. If it is not, proceed to decision step 3.
Decision step 3: if the software does perform an action on data or performs an action beyond storage, archival, communication, simple search, lossless compression, then it may be a medical device software; proceed to step 4.
Decision step 4: is the action for the benefit of individual patients?
Examples of software that are not considered as being for the use of individual patients are those which are intended only to aggregate population data, provide generic diagnostic or treatment pathways (not directed to individual patients), scientific literature, medical atlases, models, and templates as well as software intended only for epidemiological studies or registers.
Decision step 5: Is the software medical device software (MDSW) according to the definition of this guidance?
Decision steps for qualification of MDSW as either a medical device or an in vitro diagnostic medical device
Decision Step 1: Does the Medical Device Software (MDSW) provide information within the scope of the in vitro diagnostic medical device definition?
MDSW, which provides information according to Regulation (EU) 2017/746 – IVDR Article 2(2), should qualify as In Vitro Diagnostic Medical Device Software (IVD MDSW)
Concerning a physiological or pathological process or state (by investigation of this process or state)
Concerning congenital physical or mental impairments
Concerning the predisposition to a medical condition or a disease
To determine the safety and compatibility with potential recipients
To predict treatment response or reactions
To define or monitor therapeutic measures.
An MDSW that falls under the definition set out in EU Article 2 (1) of Regulation (EU) 2017/745 – MDR should qualify as Medical Device Software (MD MDSW). In specific, the following considerations should apply to the provision of information by software:
Diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease
Diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability
The investigation, replacement, or modification of the anatomy or a physiological or pathological process or state
Control or support of conception
Products specifically intended for the cleaning, disinfection or sterilisation of devices as referred to in Article 1(4) and Annex XVI products.
Decision Step 2: Does the MDSW create information based on data obtained by in vitro diagnostic medical devices only?
Suppose the information provided is based on data obtained solely from in vitro diagnostic medical devices. In that case, the software is an in vitro diagnostic medical device and is, therefore, an IVD MDSW.
If the data analysed is obtained from both in vitro diagnostic and medical devices, proceed to step 3.
Decision Step 3: Is the intended purpose substantially driven by in vitro diagnostic medical devices?
The applicable legislation is Regulation (EU) 2017/746. If the intended purpose is substantially driven by data sources coming from medical devices, then the relevant legislation is Regulation (EU) 2017/745.
In the condition where the intended purpose of the MDSW output data fulfils both the medical device and in vitro diagnostic medical device definitions set out in the MDR and IVDR, a weighting of the data sources based on the significance of the information concerning fulfilling the intended purpose should be conducted to aid the manufacturer in determining which regulation to apply.
Consideration of changes to an MDSW
Manufacturers shall evaluate the potential impact of any changes to the function, intended use, basic design, and manufacturing characteristics on the software’s qualification as MDSW and its classification.
It is to be noted that a change to or the addition of functionality to software may lead it to be qualified as MDSW or a revision of the classification of the MDSW. Similarly, a module that is added to software might be equipped as a MDSW on its own.
When determining the risk class of a combination of a modified MDSW and a medical device, the intended purpose and functionality of that (new) combination must be considered.
How MDD considered SaMD classification approach and what difference has MDR brought in it ?
Most standalone medical software falls into the lowest risk category — Class I — under the EU MDD. The only software used for specialised diagnostic activities obtained a higher classification.
This categorisation has been altered in the EU MDR. The risk classification of software is covered under Rule 11. The legislation specifies that software used for diagnostic or therapeutic purposes must be classified as Class IIa (or higher). Rule 11 was added to the MDR to address the risks associated with information provided by an active device, such as the MDSW. The significance of the information provided by the active device to the healthcare decision (patient management) in connection with the healthcare situation is described and categorised in Rule 11.
Rule 11 states:
Software intended to provide information that is used to make decisions with diagnosis or therapeutic purposes is classified as class IIa, except if such decisions have an impact that may cause:
Death or an irreversible deterioration of a person’s state of health, in which case it is in class III
Severe deterioration of a person’s state of health or surgical intervention, in which case it is classified as class IIb.
Software intended to monitor physiological processes is classified as class IIa, except if it is designed for monitoring vital physiological parameters, where the nature of variations of those parameters is such that it could result in immediate danger to the patient, in which case it is classified as class IIb.
All other software is classified as class I.
What is the transition plan from MDD to MDR for SaMD devices ?
While many devices approved under the MDD can continue to be sold until 2024, Class I items and those that have been “up-classified” due to the MDR do not have that opportunity; they must be compliant by May 2020.
The MDR regulation’s wording has been clarified – it’s all about the expiration dates of CE mark certificates. MDD-certified products can be used until the expiration date on their CE-marking certificate (a soft transition, potentially up to 2024). However, there are specific additional requirements, such as post-market surveillance. On the other hand, Class I products are self-certified and so lack a certificate with an expiration date. At the end of the transition period, they must be compliant on May 26, 2020.
How is MDSW classified under IVDR ?
In determining the proper classification of MDSW under the IVDR, the manufacturer shall consider all categories and implement the rules of Annex VIII of the IVD Regulation (EU) 2017/746.
Examples for the classification of MDSW under the IVDR:
Software intended to be installed on a fully automated enzyme-linked immunosorbent assay (ELISA) analyser, and intended to determine the Human HbA1c concentration in serum from the results obtained with a Human HbA1c ELISA, designed to screen for and diagnose diabetes and monitor diabetic patients, should be in class C per Rule 3(k).
Software within a PAP stain automated cervical cytology screening system intended to classify the PAP cervical smear as usual or suspicious should be in class C per Rule 3(h).
Software for the interpretation of automated readings of line immunoassay to confirm and determine antibodies to HIV-1, HIV-1 group O and HIV-2 in human serum and plasma should be in class D per Rule 1.
Software that uses maternal parameters such as age, the concentration of serum markers and information obtained through foetal ultrasound examination for evaluating the risk of trisomy 21 should be in class C per Rule 3(l).
Classification examples in Annex IV are provided for guidance purposes and illustrate how a particular rule may be applied to a device. The indicated classification in the example is not a confirmation of the final classification of the device, as other laws must also be considered.
What are the risks SaMD medical devices possess ?
While SaMD has the potential to improve the healthcare system significantly, the International Medical Device Regulators Forum (IMDRF), a collection of medical device regulators working toward international regulatory harmonisation, has recognised that SaMD poses new problems to medical device regulation.
Regulators face the difficult task of regulating software that undergoes frequent changes, potentially affecting the software’s safety and efficacy. Because the conventional physical constraints of containment are no longer present, the ability to download the software through the internet creates a risk.
To identify and track SaMD throughout its life, regulators and the industry must agree on globally applicable device identification and coding standard. They’re not like a standard medical device, which can be labelled with a Unique Device Identifier on the outside.
Another issue with SaMD is the software’s security. The medical device’s use may be jeopardised due to cybersecurity vulnerabilities. It could allow the attacker to take control of the device remotely, modify its operation and compromise its safety or effectiveness, or expose confidential data.
From a regulatory standpoint, the following are some of SaMD’s challenges:
Medical Device Regulations establish guidelines for categorising medical devices from low to high risk. Some SaMD do not fall neatly into the classification scheme designed for traditional medical devices.
Artificial Intelligence is already improving several SaMD systems in image-based healthcare by continuously learning from the data provided to the software.
MSDW Risk Classification based on Rule 11 of the MDR