The UK government, via the Medicines and Healthcare products Regulatory Agency (MHRA) has now published its consultation on the future regulation of medical devices in the UK. The MHRA webpage introducing the consultation is available from here, and the consultation questionnaire itself is accessible here.
As background, the current 2021 version of the 2002 device regulations is based largely on the EU Medical Device Directive (MDD, 93/42/EEC), with limited aspects of the EU Medical Device Regulation (MDR, 2017/745) included. By way of introduction to the consultation, the UK Secretary of State for Health and Social Care states: “our departure from the European Union has provided us with a newfound regulatory freedom and a unique chance to reshape our rules”, and “This consultation reflects the lessons learned in recent years and provides a platform from which we can build something truly remarkable: a life sciences sector that continues to lead the world and safeguard and advance the health of our nation.”
However, despite this perceived desire to leave the EU behind and create something new and revolutionary, at first glance the consultation appears to concentrate its questions on whether many more of the detailed requirements in the EU MDR should be incorporated into the UK regulation. So much for “leading the world”. More like “imitation is the sincerest form of flattery”.
So it looks as though the UK will end up with an MDR clone regulation, despite all the political BS, while making device manufacturers go through the certification process twice, once for the EU MDR CE mark, and then again for UK CA mark, just so that BoJo can boast that the UK has ‘got Brexit done’. This piece of political nonsense will cost the MedTech industry, and thus eventually healthcare providers and patients, potentially making some devices unavailable to patients in Great Britain (GB), because their manufacturers will consider the GB market too small to be worthwhile pursuing, given the additional costs and hassle. Patients in Northern Ireland (NI) will be saved from this madness, however, because of the NI Protocol, which keeps the country in the EU Customs Union and thus accepting of the CE mark. But watch this space, as the UK government tries to overturn this agreement as well.
If there is one piece of legislation that demonstrates the madness of Brexit, this may well be it.