Brexit and the CE Mark – implications for European regulation of medical devices
The questions are coming thick and fast about the implications of the UK’s decision to exit the European Union for the CE marking of medical devices and IVDs (and a whole lot of other things too – but let’s just stick to devices and IVDs for now).
The prospect of the UK leaving Europe raises issues for industry and for regulators alike. What’s it all going to look like? It’s very early days yet – but it’s worth looking at the question from several perspectives.
For UK domiciled manufacturers – regulatory approval in the rest of Europe will still be via the CE mark. That much won’t change. So from a regulatory perspective, Brexit should have no effect on access to the European markets. What happens in terms of tariffs, taxation and so on is a completely different matter, but regulatory approval is NOT likely to be a particular headache. (But read on about those gaining CE from a British Notified Body – which is likely to be the case for the majority of UK manufacturers).
What about manufacturers seeking access to UK markets? For reasons of practicality it seems the most likely outcome will be that the UK will have to continue to recognise CE marks – for the reasons explored below.
UK Notified Bodies
Notified Bodies are currently accredited via their national competent authority. In the case of UK Notified Bodies – accreditation is currently done by the Medicines and Health Care Products Regulatory Authority (MHRA). When the UK finally leaves Europe, that won’t be possible – as the MHRA will no longer be a European Competent Authority. However that’s not to say alternate arrangements can’t be made. There are currently Notified Bodies operating in Norway, Switzerland and Turkey – none of which are EU members, due to the operation of various Mutual Recognition Agreements. Australia’s national regulatory agency TGA also, via a Mutual Recognition Agreement, can award CE marks for some medical devices. So it’s very likely that if MHRA wants to continue anointing Notified Bodies, a way could be found.
But in the current political environment, that’s a very big “if”. So what other options exist for the UK Notified Bodies to assure their future? Given that all Notified Bodies will need to be re-accredited via the new procedures anyway over the next couple of years, the most obvious solution would be for the current UK Notified Bodies to relocate their headquarters to another European State and seek re-accreditation in their new home. Given there’s a 2 year time period for the secession process, that should give enough time for the necessary corporate restructures, however painful they may be.
So for those holding CE certification via UK Notified Bodies (Amtac, BSi, SGS, UL United Kingdom, LRQA) can sleep a little easier in that there are pathways for these organisations to continue operating and awarding CE marks.
A diminished MHRA?
Brexit could be particularly difficult for the MHRA. The European model of regulation devolves all of the premarket assessment tasks to Notified Bodies, leaving the Competent Authority to concentrate on regulation of clinical trials and postmarket aspects such as adverse event reporting and recalls. IF the UK exits the EU – the question will arise as to the nature of regulation in the UK and the role of the MHRA in that regulation.
The problem – MHRA doesn’t currently conduct regulatory assessments and approvals – that’s done by Notified Bodies. Put simply MHRA isn’t big enough to do the whole job. It seems unlikely that MHRA would be in a position recruit and train enough staff to assume this role – even given the necessary additional funding and a 2 year advance warning as implied by the EU article 50 process for a secession.
A solution may be look to the antipodes. No I am not suggesting the MHRA flee to Sydney, but that the regulatory model adopted in Australia may be a good template for a UK outside of the European Union. In effect, Australia’s TGA has established a unilateral recognition system – where for all but the very highest risk devices, TGA accepts CE certification as evidence on which to grant Australian regulatory approval. For a limited group of higher risk devices TGA does a document audit prior to registration and for the highest risk devices – Class III devices with an integral medicine or a biological component, TGA does a direct conformity assessment similar to that done in Europe. This means that most devices marketed in Australia actually gain access to the market by presentation of a CE certificate. So MHRA could take a similar approach – stick to its current postmarket and clinical trial regulatory roles and grant premarket approval based on CE certification as is done at present.
Any such shift to a unilateral acceptance of CE certification would of course mean that MHRA would lose input to the framing and operation of the European regulatory process. The balance of power is already shifting to Brussels with the change from Directives to Regulations. The question would be whether such a solution would be politically acceptable and in the feverish atmosphere in the UK right now – where one of the political hot buttons is rejection of regulation from Europe, that’s anyone’s guess.
This of course is solely from a Medtech perspective. MHRA is also the UK’s drug regulator and London currently is home to the European Medicines Agency. There’s already speculation about the EMA being forced to relocate to Europe. One things seems certain: the influence of the MHRA in framing European regulation of devices and medicines is going to be severely diminished. Europe will be losing a key player.
UK based EC Reps may no longer be able to operate to support non-European manufacturers. This will mean a need to appoint a new EC Rep elsewhere in the EU. Not a trivial undertaking and with implications for re-labelling and adjustment of postmarket processes and re-registration of devices under the new representative. Manufacturers with European offices in the UK may need to shift EC Rep functions to a mainland office – or appoint a third party.
The Rest of Europe
For the rest of Europe, it’s likely to be business as usual. The EU will be more concerned with the implementation and bedding down of the new regulations than the departure of a member state representing around 10% of the market, and where CE marks are likely to remain as bankable currency for regulatory approvals anyway.
But if this British Disease spreads and others secede (e.g. watch carefully the forthcoming French Elections for the success or otherwise of the isolationists) then all bets are off. But I would suggest then that we will have far bigger concerns than what will be a very much secondary issue of medical product regulation.
Needing to understand the European regulatory process – or how to use a CE mark to achieve accelerated access to many Asia Pacific markets? We are experienced in supporting manufacturers to attain CE certification and to leverage CE marks for multiple international regulator approvals.