Under certain conditions, the UK MDR 2002 mandates that you notify the MHRA at the time of your device’s initial sale in Northern Ireland. The manufacturer’s location, the Authorised Representative’s location, and the device class determine the specific criteria.
Requirements for Non-UK manufacturers
To sell medical equipment in Northern Ireland, non-UK manufacturers are exempt from the requirement to designate a UK Responsible Person.
To sell devices in Northern Ireland, manufacturers who are based outside of the EU or the EU must designate an Authorised Representative who is based in the EU or in Northern Ireland.
Requirements for Great Britain-based manufacturers placing devices on the Northern Ireland market
To place a device in Northern Ireland, British manufacturers must choose an Authorised Representative with a base in the EU or Northern Ireland.
Where an EU-based Authorised Representative is appointed, the manufacturer located in Great Britain is required to register with the MHRA all device classes other than Class I devices and general IVDs (those are not for self-testing)
Where a Northern Ireland-based Authorised Representative is appointed, the Authorised Representative must register all devices with the MHRA.
How can importers register?
When a product is placed on the Northern Ireland market, the Authorised Representative headquartered in Northern Ireland is required to give the MHRA information on the person doing so if they are not:
The manufacturer, or
The Northern Ireland-based Authorised Representative.
How to do the registration of custom-made devices in Northern Ireland?
On the EU market (including Northern Ireland), only devices that are custom-made in accordance with EU MDR 2017/745 are permitted.
Before May 26, 2021, custom-made devices registered under the EU MDD or EU AIMDD and sold in an EU member state other than Northern Ireland may still be registered with MHRA with the intention of being sold exclusively in Northern Ireland.
What are the details needed to register your device with the MHRA?
You are asked to provide the following information when registering your devices
Manufacturer details:
legal entity name and address as it appears on the device labelling/packaging
company type e.g., limited company, sole trader
administrative contact (you can have up to 15 people with access)
a designation letter (if any) for UK Responsible Persons. This must be a formal contract that identifies you as the manufacturer’s sole UK Responsible Person and outlines the duties you are required to perform under the terms of the agreement. Our regulatory guidance for UK Responsible Persons contains the necessary responsibilities that need to be included in the designation contract.
How to do medical device registration with the Medicines and Healthcare products Regulatory Agency (MHRA)?
The following steps are followed to register a medical device in the UK market as per the news released by MHRA on 10 Jan 2024.
What can be registered?
Before being sold in the United Kingdom, all medical equipment, including IVDs, specially designed devices and systems, procedure packs, must be registered with the MHRA.
Which regulations must they conform to?
For a device to be placed on the market and registered with the MHRA, it must comply with the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002) as they are implemented in Great Britain.
What are the registration requirements in Northern Ireland?
Devices that you have produced that are Class I, IIa, IIb, or III
Any system or procedure pack that includes at least one medical equipment, whether it be a Class I, IIa, IIb, or III device that you have refurbished or re-labelled under your own name
Custom-made devices
IVDs that you have manufactured and are undergoing performance assessment.
How to register your device to be placed in Great Britain Market?
A single UK Responsible Person must be designated by the manufacturer if their headquarters are located outside of the UK to assume accountabilities for all their medical devices.
Note: Since January 1, 2022, the MHRA registration system has suspended the accounts of any represented manufacturers and any former Authorised Representatives based in Great Britain who have not updated their role to UK Responsible Person. This suspension will continue until the UK Responsible Person has updated their role.
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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
Authorized Representatives
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
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.
Authorized Representative
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.
Importer
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 Registration
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.
4. Verification
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
Post-Brexit
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.
Symbolic Absence
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.
Conclusion
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 apps are increasingly growing these days. MHRA has issued new guidance on the stand-alone software medical devices, including apps. This guidance is a crucial document for manufacturers and users of such medical devices.
In the UK, medical devices are subject to UKCA marking. The UKCA marking is no exception to software medical devices.
Software Medical Devices or not
Classifying software or a mobile app as a medical device can be challenging. If the software or app has a well-defined intended medical purpose, it is essential to mark CE or UKCA on the product.
This ensures that the device conforms to the requirements of the regulation of the EU and UK and is safe for use. The flow chart provided below helps determine if the software is a medical device, in vitro diagnostic device, active implantable, or accessory.
Flowchart on the classification of software into medical device Source: MHRA Software flowchart
Intended purpose
A medical device is defined by the intended purpose on the device labelling, Instructions for use and any promotional materials, including brochures.
Depending on the intended purpose, the device can be classified as a device with a medical purpose if it:
Prevents disease
Diagnoses a disease, injury or handicap
Monitoring a disease, injury or handicap
Treats or alleviation of a disease, injury or handicap
Compensates an injury or handicap
Investigates replaces or modifies anatomy or physiological process
Controls conception
A software device is considered to have a medical purpose if it has one of the following features and looks into in vitro data:
Concerning a physiological or pathological state
Concerning a congenital abnormality
To determine the safety and compatibility with potential recipients
To monitor therapeutic measures
Software Medical device classification and essential requirements
Rule 9 includes active therapeutic devices intended to administer or exchange energy
Rule 10 includes active devices intended for the diagnosis
Rule 12 includes all other active class I devices
Rule 14 includes devices used for contraception or the prevention of the transmission of sexually transmitted diseases
One of the essential requirements for software apps is for the benefit to outweigh any risks. Essential requirements also state the risks of ergonomic features and the intended use environment.
Manufacturers of such devices must ensure that the user interface must be consistent, and graphics and text must be clear and legible. The software or app must be designed with safety in mind.
In addition, the clinical evaluation following Annex X of the UK MDR must be done. A similar set of requirements applies to IVDs.
Labelling requirements
The software labelling must be clear and visible to the user. Manufacturers must ensure the app meets relevant requirements and displays UKCA marking on the landing page itself.
The following particulars must be present on the software label:
App name
Version number
Date of manufacture
Manufacturer name and address
UKRP name and address
Purpose of software
Warnings and precautions
UKCA or CE marking
Labelling for an app with medical purpose
Examples of Software with a medical purpose
Software with a medical purpose may be devices that:
Provide information for the calculation of drug dose using IVD data such as blood
Enables therapeutic drug monitoring
Monitor blood glucose levels
Provides medical conditions based on input user data
Indicate potential developing disease based on the entered data
Automate the pathway for treatment for an individual
Enables people with visual or hearing disabilities to read or listen by magnifying text or amplifying sounds
Software or app without an intended medical use would include:
General apps for recording patient images which later require the diagnosis of a clinician
Apps that give general recommendations instead of user-specific advise
Software that is intended to record heart rates, such as fitness or sports apps
Apps that remind patients of drug intake
Apps to treat non-medical conditions
Software that provides tips or advice
Disclaimer: Regulations/legislations are subjected to changes from time to time and the author claims no responsibility for the accuracy of information.
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.
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.
