We recently provided an overview of the UK’s medical device regulations and its impact in transitioning lateral flow medical devices from EU CE marking to UKCA (UK Conformity Assessed). However, it has come to light the UK authorities have added an extension for this transition period. But this has been caveated with a warning this is not a time slow the process in meeting UKCA criteria. Therefore, our Head of Regulatory, Candice Vendettuoli, covers the UKCA extension in more detail and the negative consequences of waiting to meet UKCA.
The Extension Period And The Impact
On the 25th of October 2022 the MHRA (Medicines and Healthcare products Regulatory Agency) announced that the mandatory deadline to achieve UKCA marking is extended by 12 months to July 2024. Any CE marked device will continue to be accepted for registration with the MHRA until the end of June 2023.
As of the 1st of July 2024, all new medical devices placed on the Great British market will only be accepted if UKCA marking has been achieved. Currently, UKCA marking is achieved by meeting requirements of the IVD Directive, and this will be replaced by new regulations in the near future.
The transitional arrangements described in our previous blog UK’s medical device regulations remain unchanged aside from the date having moved. The 5-year transitional period is now applicable for any medical devices that are CE marked or UKCA marked and placed onto the market before July 2024.
Why You Shouldn’t Wait
Whilst this extension will be very well received by many device manufacturers in the UK and overseas, 12 months is not a very long time. In addition, in the announcement made on the 25th of October 2022, the MHRA also describe that new legislation for transitional arrangements and post market surveillance will be introduced in Spring 2023.
To ensure the safety and performance of all devices placed onto the UK market, the MHRA intend to introduce post market surveillance requirements ahead of the new UK regulations being introduced. The combination of these UK requirements and additional transitional requirements for IVDR in the EU, mean test owners will have many tasks to juggle, more so than ever before. So now is not the time to relax. It is important that test owners’ systems and processes are in place and effective to ensure success during this ever-changing medical device regulatory environment.
The Key Take-Away
While it would appear the MHRA’s extension to meet UKCA requirements is welcome by most, the complex nature of regulations should not be taken for granted. When applying for a UKCA mark, lateral flow product owners need to know what is required to meet these new regulations in line with commercial timelines. Knowing the complexities involved, it is strongly recommended not to rush a UKCA mark application, and to start it early.
The good news is that support available through Abingdon Health’s in-house regulatory expertise. We can support you through the UKCA mark process and make sure your product introduction or re-certification is as smooth as possible. Contact a member of our team to discuss this subject in confidence.