The world of medical device regulation has seen immense change in past years. The EU MDR has been at the forefront of every agenda for some time – and the one-year deadline delay provided valuable extra time for businesses to get their act together. That one-year delay also meant that the EU MDR was not implemented into UK legislation before the UK exited from the EU. The UK’s departure from the EU has now added a whole new set of regulatory requirements into the mix. Trading with the UK just got a bit more complicated!
We know it’s a lot to handle so we created this blog series to help businesses get to grips with their post-Brexit requirements. Today, we’re looking at UK Approved Bodies – which have replaced their EU equivalent Notified Bodies. Conformity assessments for certain device classifications for the UKCA mark now rely on UK Approved Bodies.
The criteria for selecting a UK Approved Body are no different to those used for selecting an EU Notified Body: Are they designated for the application regulation? Are they designated for the product codes applicable to your products? And do they have capacity for new clients and cost?
The challenge here is that only three organizations have been designated as UK Approved Bodies to date. Of those three established organisations, only two of them have broad scopes (i.e. can assess various medical device types and classifications), whereas the third organisation currently has scope for a limited selection of IVDs only. This means the former will face significant demand as manufacturers compete for their services to meet the UKCA compliance deadline in June 2023. At least one of these organisations will also be very busy as the EU MDR and IVDR transition periods come to an end in 2024, and this may impact on their ability to support new submissions.
To overcome this issue, the MHRA may need to encourage the formation of new UK Approved Bodies, incentivise existing EU Notified Bodies to become UK Approved Bodies, or take on some of the role of a conformity assessment body itself. Existing UK Approved Bodies may wish to expand their coverage to include high-risk medical devices, which only a few EU Notified Bodies are currently able to assess.
As these solution pathways may require more time than is available, it is crucial that medical device manufacturers do not underestimate the importance of contacting a UK Approved Body early on. Delaying the start of communications increases the chance of missing out on access to the submission review and approval services needed to obtain their UKCA mark. The idea is to anticipate delays – start preparing documentation as early as possible to allow enough time for any issues in the submission to be addressed and rectified.
Businesses can start this process now by contacting one of the UK Approved Bodies on the list. If manufacturers with CE marked devices have no existing relationships with an existing Approved Body, they can reach out to their EU Notified Body and find out if they intend to become a UK Approved Body.
Alternatively, manufacturers can monitor the list of UK Approved Bodies as other conformity assessment bodies continue to enter the UKCA market. New entrants to the UK market should consider whether to apply for a CE mark and UKCA mark in parallel, or whether to prioritise one before the other depending on market roll out plans, regulatory strategy and predicted timelines from EU Notified Bodies and UK Approved Bodies.
About the author:
Ed Ball is a Senior Consultant at RQM+ and formerly worked as a medical device specialist at the UK Medicines and Healthcare products Regulatory Agency (MHRA), and is currently an active member of the UK’s Technical Committees for Medical Device Quality Management and Risk Management standards. He is an accomplished medical device specialist and chartered engineer, who combines a technical understanding of medical devices with regulatory and quality management experience. Ed has 15+ years of practical experience with a wide breadth of medical devices, including but not limited to EU Class I – III, active devices, implantable devices, diagnostic devices, measuring devices, devices used by lay people, and sterile devices.