Cheerio CE Marking – UK MHRA Adopts New Medical Device Registration Scheme on January 1, 2021
If you have worked in European regulatory affairs for some time, it’s hard to wrap your brain around the fact that the United Kingdom is no longer part of the European Union. Moving forward the UK will forge its own path, interacting with its continental neighbors in a manner similar to Norway. Yet the key difference is that Norway has chosen to emulate the EU Medical Device Regulation (2017/745) as national law and require CE Marking. The UK, not so much at the moment.
In September 2020 the UK MHRA further ensured job security among medical device regulatory professionals by moving to continue with Brexit mandates not utilizing European CE Marking and instead implementing their own registration and marking scheme.
Overview of the UK Registration & UKCA Mark Scheme
An understanding of the new UK MHRA medical device registration requirements starts with a basic UK geography lesson. Brexit created many logistical and political headaches, one of which is what to do about cross-border trade between Northern Ireland and Ireland (an EU member). As such, a scheme was created that treats Northern Ireland and Great Britain (England, Wales, Scotland) differently from a regulatory perspective, even though all four regions are part of the UK. This is the side effect of an effort to prevent a “hard border” between Ireland and Northern Ireland.
The MDD Will Remain in Effect…For Now
So, what happens on January 1, 2021?
Currently the UK has transposed the existing Medical Devices Directive (MDD 93/42/EEC) into national law, and it will continue to be effective after January 1, 2021 and until the new EU Medical Device Regulation (MDR) implementation date in May 2021. As of September 2020, a new bill is making its way through the legislative sausage-making process and will allow the existing UK device regulations to be amended or replaced. It remains to be seen if the new version will closely follow the EU MDR or be notably different.
The New UKCA Mark
Starting January 1, 2021, medical device manufacturers will be able to apply a new UK Conformity Assessed (UKCA) Mark to their device labeling for products sold in England, Wales, and Scotland. This means that if you have a current, valid Declaration of Conformity or CE Marking certificate, you automatically meet UKCA mark requirements. However, you will not need to modify your existing labeling to add the UKCA mark until July 1, 2023. After UKCA it will be mandatory, but dual labels with the CE and UKCA Marks will be acceptable.
As for new devices, a UK Conformity Assessment Body will need to a conduct an assessment for compliance with the UKCA mark requirements. Existing UK Notified Bodies under the European MDD most likely will continue to be designated for UKCA conformity assessment according to CE Marking. However, note the conformity assessment will be against the UK medical device regulations, which follow the MDD. It is not clear yet what will happen after the EU MDR compliance date of May 2021 or if revised UK medical device regulations will require redesignation of these UK-based Notified Bodies to a UK Conformity Assessment Body.
Confusingly, the UKCA mark will not be recognized in Northern Ireland, which will still require CE Marking on labeling, so manufacturers need to keep this in mind. We’re not sure why the MHRA did not call it the GBCA Mark (Great Britain Conformity Assessed). Perhaps they felt such a moniker would be even more confusing.
Appointing a UK Responsible Person
In addition to the new UKCA mark, manufacturers located outside of the UK will need to appoint a UK Responsible Person prior to registration. This applies to products sold in England, Scotland, or Wales (collectively Great Britain). Similar to the EU Authorized Representative, the UK Responsible Person will be responsible for registering devices with the MHRA, ensuring that a Declaration of Conformity has been drawn up and that technical documentation exists. Various other responsibilities apply as well.
For devices sold in Northern Ireland, things get really tricky. If the manufacturer is located in Great Britain, an EU Authorized Representative is required, not a UK Responsible Person. If the company is located outside the UK, a UK Responsible Person will be required.
The Legislative Process Is Still at Work
The process of untangling nearly 50 years of political, trade, and legal integration with the EU is messy and ongoing. There is plenty more to do, and the MHRA is surely working hard to establish a new framework for regulation of medical devices in the UK. As things evolve, Oriel STAT A MATRIX will keep you updated.