Brexit and the CE Mark – implications for European regulation of medical devices
Arthur Brandwood – June 26, 2016
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). ‘Brexit’ 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 (although more drastic) 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.