Oct 7, 2020

On both sides of the North Sea and La Manche the positions regarding the future relations between the UK and European Union appear to be hardening. On the one hand is the UK government now changing their mind on the withdrawal agreement they signed less than a year ago. On the other hand, a form of battle fatigue appears to linger around in Brussels. This may very well result in a no-deal situation after December 31. It is very unlikely a deal allowing free trade between UK and EU will be struck in time, which means that a no-deal situation has become very likely. The only way out of this would be that the UK government manages to regenerate the two-year extra extension to the transition period, which they should have asked for before July 1, 2020. That extension may probably be granted by EU Member States, but there may be a price for that request.

In short: a no-deal situation after December 31 is likely, but not a certainty.

UK MHRA preparations

The UK government, represented by the Medicines and Healthcare products Regulatory Agency (MHRA), is preparing for this no-deal situation. MHRA is very well aware that even small disruptions in the supply of medical devices may have serious consequences for the continuity of care in the UK healthcare system. Therefore they want to ensure companies have sufficient time to adapt to the new situation. In a way they want to create a transitional period for medical devices as soon as the UK withdrawal transitional period ends.

A key factor in that approach is that MHRA wants economic operators to support the regulator’s effort to keep devices safe and compliant. The fundamental change for MHRA will be that, where currently 28 Member States do their market surveillance for all devices placed on the EU market, MHRA will now have to do all that work on their own for almost the same number of devices. Therefore the UK wants economic operators to take a lot of responsibilities themselves, with MHRA only looking into situation where this is not done appropriately. However, none of these arrangements can be found in formal legislation yet.

In short: industry may start preparing based on current guidance documents, but all should be aware that final official requirements may be different.

Placing devices on the UK market under no-deal conditions

This approach will require UK manufacturers to keep working according to the current EU Medical Device Directives and move towards the UK copies of the new Medical Devices Regulation (MDR) as appropriate. Non-UK manufacturers must appoint a UK Responsible Person (UKRP) who will be responsible for regulatory communication with MHRA. Importers must register themselves with the UKRP, who must inform MHRA. How this will work out in practice still needs to be further developed. But key in this approach is that non-UK manufacturers must appoint a UK based UKRP if they want to have devices placed on the UK market after December 31. There are a few scenarios for non-UK manufacturers:

  • A non-EU manufacturer is already using a UK-based Authorized Representative; in such cases it is likely that AR will start acting as a UKRP.
  • A non-EU manufacturer is using an EU27-based AR; they need to appoint a UK-based UKRP in parallel with the AR.
  • An EU based manufacturer must appoint a UK-based UKRP.

In all of the above situations a company placing devices on the UK market must register as an importer with the UKRP, who will inform MHRA.

In order to keep the burden limited, it is not necessary to change labelling to add details about the UKRP or importer. However, this may change in relation to the UK Conformity Assessment (UKCA) mark, which will replace CE Marking. The UKCA mark will become mandated after June 30, 2023.

In short: non-UK manufacturers should start selecting and appointing a UKRP now.

Northern Ireland remains complex

So far the UK insists there will be no hard border between Northern Ireland and the Irish Republic. This means that Northern Ireland will remain part of the EU Single Market. MHRA is intending to act as the competent authority for Northern Ireland, but it is not clear how that will work with the other EU competent authorities. For example, competent authorities must work together with the European Commission and ultimately they will accept rulings by the European Court as the final interpretation of legislation; also, European competent authorities have access to specific EU market data. At this moment there are no agreements in place to set any of this up for Northern Ireland.

A further complicating factor is that the UK is developing legislation that cancels part of the withdrawal agreement. This is not appreciated by the EU, and this law may be put forward as a bargaining chip to ensure a prolonged transitional period. We all will have to wait and see how this will work out.

In short: the Northern Ireland situation is unclear and unpredictable. At this moment it is not possible to prepare effectively.

Ronald Boumans is Senior Consultant, Regulatory Affairs at Emergo by UL.

Additional UK and European medical device regulatory resources from Emergo by UL:

 

Author

  • Ronald Boumans

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