The United Kingdom’s exit from the European Union has had far-reaching ramifications for a wide range of industries, including medical device manufacturing. If you’re a medical device firm selling – or looking to sell – into the UK, significant changes are coming in January that can have a major impact on your plans. From January 1, 2021 the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) will take on the responsibilities for the UK medical devices market that are currently managed through the EU system.
There will be a number of changes affecting how medical devices are sold in Great Britain, which includes England, Scotland, and Wales. The changes will include:
- CE marking will continue to be recognized in Great Britain until June 30, 2023.
- Certificates issued by EU-recognized Notified Bodies will continue to be valid for the Great Britain market until June 30, 2023.
- After the transition period, the EU will no longer recognize UK Notified Bodies.
- UK Notified Bodies will not be able to issue CE certificates (other than for the purposes of the “CE UKNI” marking, which will be valid in Northern Ireland) and will become UK Approved Bodies.
- A new route to market and product marking will be available for manufacturers planning to sell a device in the UK.
- All medical devices, including in vitro diagnostic medical devices (IVDs), placed on the UK market will need to be registered with the MHRA. There will be a grace period for registering:
- Class IIIs and Class IIb implantables, and all active implantable medical devices and IVD List A products must be registered starting May 1, 2021.
- Other Class IIb and all Class IIa devices and IVD List B products and Self-Test IVDs must be registered starting September 1, 2021.
- Class I devices, custom-made devices and general IVDs (that do not currently need to be registered) must be registered after January 1, 2022.
- Manufacturers of Class I devices, custom-made devices, and general IVDs that are currently required to register their devices with the MHRA must continue to register their devices after January 1, 2021 on the same basis as they do now until the new registration requirements start to apply to those devices.
- If you are a manufacturer based outside the UK planning to sell a device in the UK, you will need to appoint a UK Responsible Person who will take responsibility for the product in Great Britain.
New medicines and medical devices legislation is currently in committee stage in the UK House of Lords in the form of the Medicines and Medical Devices Bill. The Bill is framework legislation, which will enable secondary legislation to be made for human medicines and devices. At this stage, the secondary legislation has not been published. It is currently anticipated that the UK parliament will adopt the MDR and IVDR under the Bill.
COVID-19 and its effect on MDR and IVDR implementation in the UK
The EU Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Device Regulations (IVDR) were due to be implemented across the EU and UK starting May 26, 2020. However, in early April 2020 the EU Commission proposed a one-year extension of the implementation date to avoid disruption and additional burdens on medical device manufacturers during the COVID-19 pandemic. This delay was approved by the EU Parliament and Council on April 23 and the new implementation date for the MDR is now May 26, 2021.
If this COVID-19 extension had not occurred, the MDR would have taken effect in the UK starting May 26 and would have become part of UK legislation as “retained EU law” under Brexit withdrawal legislation. Under this legislation, any retained EU law continues in full effect after December 31, 2020 unless changes are made by the UK parliament.
If you would like to learn more about Brexit’s potential impact on your UK marketing plans, as well as the latest regulatory issues affecting the EU, please contact the international medical device compliance and regulatory consulting experts here at MEDIcept.
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MEDIcept Inc. is an international consulting firm specializing in medical device, IVD, and biotechnology Regulatory, Quality, and Clinical Services. Since 1996, we have worked with thousands of companies to solve their most critical FDA and ISO issues. Our integrated solutions are rooted in our direct experience and span all stages of the product life.
Our staff includes former FDA and ISO personnel and industry experts with an in-depth functional knowledge of medical devices. Medical device compliance requires the navigation of a maze of requirements. MEDIcept can interpret FDA regulations, guidance documents, and ISO standards and provide clients with the information they need to comply in a safe and cost-effective manner.
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For additional information, please contact Susan Reilly at SReilly@MEDIcept.com.