You could say it has been a challenging few years for medical device and in vitro diagnostic
manufacturers in the UK and EU when it comes to regulation.
Developments in all areas of technology, especially in medical device software (MDSW or Software as a Medical Device – SaMD), means that the pace of innovation is inevitably faster than the updates in medical device/diagnostic regulations. To add a further complications, Brexit saw the UK’s departure from the European Union, to follow its own path replacing the CE mark with the UKCA mark, not to mention the unusual position that leaves Northern Ireland following EU regulation, distinct from Great Britain. However, concerns around how quickly manufacturers can digest the changes and comply with the regulations has seen both the EU and UK push back important deadlines. So…where are we now?
The MHRA announced on 28 April 2023 ( https://tinyurl.com/2s4ypmuy), that subject to approval by Parliament (by 30 th June 2023), that a statutory instrument had been laid down, to
- Delay introduction of the medical regulatory framework from July 2024 to July 2025
- Enable an extended timeframe for continued acceptance of CE marked medical devices on the ‘Great Britain’ market until as long as 30 th June 2028 (medium and low risk devices that were certified previously under the ‘MDD’)
This therefore allows manufacturers more time to focus on UKCA marking of their products for the future, but is this good or bad?
Here at InViva, we urge manufacturers to take a breath of relief, but not to procrastinate when it comes to planning for UKCA certification. There are substantial benefits to acting now, especially for existing CE marked Class I devices where a UK Approved Body is not required for re- certification. Push on with self-certification after addressing the Essential Requirements under the current regulatory framework, make the changes to your labelling (or software) and then apply the UKCA mark.
If you have products that are Class IIa or higher, they will need to go through conformity assessment with a UK Approved Body. Whilst they are currently increasing capacity to undertake assessments, it will still cause bottlenecks in the future if all companies think the same and there is another rush to Approved Bodies around the same time. Delaying is likely to increase risk as well as facing increasing costs due to inflation.
For more information on implementation of the future regulations from the MHRA that will likely apply from 1st July 2025, please visit https://tinyurl.com/4xk923vu.
If you would like to discuss any regulatory matter with InViva, please contact us via
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