Medical device Brexit Roundtable looks at sector’s challenges
Posted on 8 May 2019
Regulatory affairs delegates from the medical device sector gathered on 26 April 2019 at TOPRA’s headquarters in London, UK, to reflect on the implications of the UK’s withdrawal from the EU and how to achieve the best outcomes for the future.
The UK’s delayed exit from the EU on, potentially, 31 October comes at a time when Europe is going through major changes pertaining to the medical device industry, particularly with the introduction of the new EU Medical Device Regulation (MDR) (in force from 2020).
Below are highlights from the roundtable discussion.
It seems likely that only a handful of notified bodies will be certified in time to be able to provide EU Medical Device Regulation (MDR) certification. It seems unlikely, therefore, that all those companies needing MDR certification before 26 May 2020 will actually receive those certificates in time.
Brexit and Notified Body crisis
Although it would have made some sense for UK notified body certificates to be recognised for a period after Brexit – and perhaps even during the MDR and In Vitro Diagnostics Regulation (IVDR) transition phase to ensure continued availability of devices on the EU market – the EU Commission has expressed a view that member states should not do this on an individual basis.
The Commission also did not want the orphan manufacturer grace period used to fill the gaps in notified body certification resulting from Brexit. [Our experience at Fieldfisher is that some competent authorities are willing to grant these.]
This means that, from the Commission’s perspective, individual product derogations would be the only means to obtain some flexibility, where needed, to ensure products can continue to be placed on the EU market. [Our experience of obtaining derogations is that this is a time-consuming and expensive process because every country has its own requirements. Many countries will only grant them in extremely limited circumstances and they and others require a significant amount of documentation to be provided, such as letters from customers or distributors. They are also only granted for a limited period and must be reapplied for regularly.]
No UK CA marking
The UK Medicines and Healthcare products Regulatory Agency confirmed that there is, at present, no requirement following Brexit for manufacturers to include a UK competent authority mark on their devices.
Products ‘placed on the market’
The question was raised whether products that were placed on the EU market before a hard Brexit date in the UK can then be validly transferred into an EU27 country without it being classified as an import from a third country. While in theory it ought to be the case, as the product has already been placed on the EU market, attendees agreed that customs officials at the border into the EU27 might not accept this. It would therefore be prudent to assume that such products will be treated as an import into the EU from a third country and, where possible, to ship product to the EU27 before any hard Brexit rather than storing in the UK.
Future of medical device regulation in the UK
Regulating medical devices under a system over which the MHRA has no influence is not likely to be acceptable to the UK government in the longer term. Therefore, if the UK is not part of the EU, the MHRA is likely to develop a standalone regulatory system and will most likely diverge from the EU approach to medical device regulation.
– By Alison Dennis, Partner, Life Sciences, Fieldfisher, UK