In April last year, because of the priority of the Medtech industry to focus on the COVID pandemic, the European Commission postponed the application of the European Medical Device Regulation 2017 (EU MDR) by one year to 26th May 2021.
This delay gave the industry some respite allowing it to focus on other more pressing priorities but with the start of the new year the application of the EU MDR is now only five months away. And for companies based in the UK … what is the impact of Brexit and the negotiated deal on meeting medical device regulations?
The EU MDR will apply fully in EU Member States from 26th May 2021 … but as they take effect after the end of the Brexit transition period they will not be EU law automatically retained by the EU Withdrawal Agreement Act and will not automatically apply in Great Britain.
So what does this mean?
The provisions contained within the EU MDR will not be transposed into law in the UK and will not be implemented (apart from Northern Ireland who will adopt MDR EU).
The UK will carry on with the Medical Device Directive 93/42/EEC 1993 (EU MDD) which is given effect in UK law through the Medical Devices Regulations 2002 (UK MDR 2002). However, on the horizon is the Medicine and Medical Devices Bill which builds on UK MDR 2002 to give added protection to patients and increase the scrutiny of medical devices that reach the UK. It is thought that this will strengthen the UK MDR 2002 and bring it closer to EU MDR.
There are very few Medtech companies that supply only to the UK market and in anticipation of the strengthening of the regulations many companies are increasing their efforts to meet the EU MDR.
The starting point is to determine if your medical device classification changes under EU MDR. If it does the requirements of the EU MDR can change significantly.
The next step is to consider is meeting the General Safety and Performance Requirements (Annex 1), especially Risk Control (Chapter 1) and providing technical documentation (Annex 2).
A stumbling block organisations may have in complying with the EU MDR is the principle of no ‘Grandfather Rights‘. Rather than being able to rely on the satisfactory performance of a device in the market to demonstrate compliance, reports and information to justify the management of risk control must be demonstrated.
Even if your device is Class 1 self -declared, your quality management system has to meet all the quality system requirements in Article 10 of EU MDR.
Fortunately there is relief for some device manufacturers through the second Corrigendum to the EU MDR issued late 2019. If you have a Class 1 medical device by MDD (now UK MDR 2002) that will need notified body involvement by being up classified by the MDR, you can continue to put it onto the market until 26th May 2024 if there are no significant changes in the design or intended purpose after 26th May 2021 and a Declaration of Conformity has been issued prior to this date. This Corrigendum extends the date of application for EU MDR for such devices to May 2024.
Understanding the EU and UK medical device regulations can be a challenge … but PS Partnerships can guide you through the process. If you need support with documentation, device risk assessment or conducting medical device compliance audits get in touch at email@example.com to see how we can help.