Update
In 2016 UK government agreed to changes in current medical device legislation and formally adopted a new piece of legislation, Regulation (EU) 2017/745, on 05 April 2017. This came into force within the UK on 25 May 2017 and included a 3 year transition period, with a full enforcement application date planned for 26 May 2020.
Due to the spread of Covid-19, EU parliament extended the application date of Regulation (EU) 2017/745 by one year (26 May 2021) to allow manufacturers more time to adopt compliance systems while managing pandemic operating conditions.
From the outset this legal initiative has been a joint EU-UK venture. However, during the latter half of 2020 negotiations between EU and UK, regarding previously agreed BREXIT arrangements (including the implementation of new medical device regulation), became less clear.
In addition, UK government recently passed the UK Internal Market Bill with the intent for this to become law before the UK leaves the EU on 31 December 2020. This legislation will give the UK powers to amend the terms of previously arranged UK-EU withdrawal agreements.
Consequently, in September UK government published guidance stating that proposed (EU) medical device Regulation will now not be applicable within the UK. At the same time MHRA also published new guidance regarding the regulation of medical devices after 01 January 2021:
https://www.gov.uk/guidance/register-as-a-manufacturer-to-sell-medical-devices
Outcome
This latest guidance simply reaffirms the necessity to register UK based custom-made medical device manufacturing activities with MHRA, if you (the manufacturer) meet certain conditions, with no immediate change to current Directive based legal requirements.
It is clear that, from 01 January 2021, legal responsibility for the quality and development of all UK medical device manufacture and use will divert away from Brussels and fall entirely onto MHRA.
There are now two issues. 1) Both EU and UK legislators have formally recognised that previous medical devices legislation was not fit for purpose and that change was a necessary imperative for patient safety. 2) As the sole arbiter of UK medical device legislation, MHRA will have to undergo organisational transformation to meet their (now amended) post-BREXIT obligations.
With regard to the above, we can assume that, during the next 12-18 months, there will be further changes/amendments to UK legislation that effects medical device manufacturing activity.
It is probable that any new UK legislation will mirror the terms of Regulation (EU) 2017/745. However, the UK-MDR version is likely to outline additional MHRA powers and recognise that the majority of UK medical device use is carried out by the state (NHS).
Mark Cutler
07 October 2020
