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Brexit Delay Gives EU27 Yet More Time To Grow Number Of EU-Compliant Devices

News article posted on 15 April 2019 on Medtech Insight
Author: Amanda Maxwell  |  Source of Original Article

Executive Summary

Has the European Commission done enough to allow UK-certified medical devices to continue on the EU27 market in the event of the UK dropping out of the EU without a deal – a possibility that remains very real?

The European Commission says that no “EU-level contingency action” has been identified as necessary for medical devices in the event of a no-deal Brexit.

It made its comments in an April 10 document, issued just two days ahead of the European Council agreeing to grant the UK a new delay in Brexit lasting until Oct. 31, 2019.

The statement comes in the light of the Commission’s long-term position on Brexit which made clear, among other things, that if the UK dropped out of the EU without a deal, then CE marks issued by UK notified bodies would no longer be accepted on EU territory after the Brexit date. (Also see “Commission Spells Out Non-Recognition Of UK Organizations In Future EU” – Medtech Insight, 17 Jan, 2018.)

This looked set to threaten the availability of some much-needed and particularly high-risk devices on the EU market.

The EU position has contrasted starkly with the UK position: the UK would allow medical devices and IVDs certified by EU notified bodies onto the UK market for a “time-limited period” after Brexit.

Although, ironically, the UK would no longer be accepting products CE-marked by its own notified bodies from that date.

National Derogation Is EU Answer

The reason the Commission considers no EU-level action to be necessary is because, it says, EU member states can use existing national derogations that are outlined in the current medical device directives to allow UK products onto their markets.

These derogations are referred to in a recently issued Annex to that long-term agreement focusing on medicinal products and medical devices – a coordinated approach in case of a withdrawal of the UK from the Union without a deal.

In this document, the Commission states that the derogations may allow member states, in duly justified cases, to authorize UK certificate holders to continue placing their products on the market in the territory of the member state concerned for a limited time.

So, does this mean that each member state will make its own decisions based around what it considers necessary, resulting in a patchwork response to the  availability of some devices?

It seems that the Commission is trying to avoid this, since – despite arguing that it there will be “no EU-level contingency action” – the Commission has said it will coordinate a transparent and coherent use of the national derogations by member states across the EU to avoid any fragmentation of the Single Market.

“Preparation actions … exemptions and derogations are expected to significantly mitigate the risk of shortages of medicinal products and of critical medical devices in case of a no-deal.” – European Commission

But the time needed to agree to a national derogation policy, derogations for individual devices, and then coordination of responses, could still threaten some products reaching EU27 citizens.

Majority Of Products Will Be Compliant

The Commission is much more upbeat than the industry has been in terms of the sense of the EU being prepared for Brexit. It believes that use of the derogation will be limited as, in terms of preparation, “the majority of medical products concerned by the UK withdrawal should be compliant with EU legislation on the withdrawal date.”

Moreover, it made this statement fully expecting that the withdrawal date could have been March 29 or April 12. So, Medtech Insight notes that there is likely to be even more optimism now that there is longer period for all stakeholders to act.

Those Not Ready Have Themselves To Blame

The Commission had called on stakeholders to prepare for the eventuality of a no-deal as early as May 2017, when issuing its first notice on medicinal products, the Commission says in this most recent Annex document (see above).

“Several notices and question-and-answer documents on … medical devices have been issued and regularly updated since. The notices invite relevant stakeholders to get prepared for the eventuality of a no-deal withdrawal … and identify all the required actions,” it says.

Economic operators are responsible for taking the necessary measures to ensure their continued compliance with EU legislation, the Commission points out. It says this includes regarding EU-localization requirements for certain functions (e.g. authorized representatives for medical devices) and activities, as well as “the replacement of UK-competent authorities and UK notified bodies by EU27 authorities and EU27 notified bodies in the approval process for placing products on the EU market.”

What The Commission Is Doing To Mitigate Risk Of Shortages

However, it is possible that, despite best efforts, some medicinal products and medical devices may not be compliant in time and thus there could be a risk of shortages if economic operators do not act swiftly to remedy the situation, the Commission notes.

The Commission and member states will, therefore, continue to monitor closely the progress of ongoing preparedness actions and provide support to affected stakeholders.

In medical devices, the Commission is working closely with the EU27 member states in the context of the Medical Device Coordination Group (MDCG) and the Competent Authority for Medical Devices (CAMD) network to monitor the progress of certificate transfers and identify critical medical devices that may be at risk of shortages.