Fog in the Channel: a European Medtech Perspective on Brexit

USe under Creative Commons license https://creativecommons.org/licenses/by/2.0/legalcode

An apocryphal newspaper headline reported, “Fog in the Channel – Continent Cut Off”. All very whimsical and a metaphor for a peculiarly anglo-centric world view. But as the UK stumbles towards the March 29 cutoff, it’s worth reflecting on what this whole Brexit process means from the other side of the channel – there are big disruptions there too.

UK Assessment Capacity

First some numbers on Notified bodies. It’s estimated that something like 45% of medical devices marketed in Europe were CE marked by UK notified bodies. Even worse, for devices manufactured outside of Europe, that figure rises to 70%. These figures are repeated by many sources and it’s unclear how accurate are the estimates – but if they are even close to the truth then Europe has a problem with losing a very substantial proportion of its assessment capacity. Now the UK Notified Bodies are making various arrangements to transition their customers to alternate providers within Europe – but it’s all going to take time and some are better prepared than others. And it seems the Netherlands Competent Authority will have several extra Notified Bodies to supervise as BSi and others go Dutch.

45% of medical devices marketed in Europe, and 75% of devices manufactured outside of Europe were CE marked by UK notified bodies.

MHRA – a particularly Competent Authority

Last week the UK Medicines and Healthcare Products Regulatory Agency (MHRA) put out an announcement that notwithstanding the UK government’s wish for a negotiated departure from Europe, it was “accelerating and intensifying” planning for medical devices regulation in the event of a No-Deal Brexit – just in case. Just like the UK Notified Bodies, the MHRA has carried a disproportionate load in European medical devices regulation. MHRA has provided substantial leadership and expertise in crafting the regulations and in the management of some of the more politically challenging regulatory issues of recent years. Look back at the development of technical positions on things like software as a medical device and postmarket management of things like the ASR hip and surgical meshes and MHRA experts were in the vanguard of the European response.

MDR Transition impact

So as Europe heads into the business end of the transition from Directives to Medical Device and IVD Regulations, there is substantial disruption to the operations of at least half of the assessment capacity, plus the loss of a significant source of technical and regulatory expertise in the MHRA. (The same is happening in medicines of course – where the European Medicines Agency has already been living in temporary offices in Amsterdam having quit its London home of 24 years).

Now all of this can be repaired in time through new cooperation arrangements, especially if the UK pulls off a properly negotiated and orderly exit (or gives up on the whole idea). But it’s certainly true that Brexit will cost the Europeans as well as the British.

Meanwhile, it seems all we can do is hope for better weather.


Help button-Quick Call-Brandwood BiomedicalWe offer deep support for manufacturers navigating European and other international regulatory processes. Whether it’s a strategy for MDR transition, or specific help with regulatory documents (e.g. Clinical Evaluation Reports), or an update of your quality system to gain MDSAP. We understand you need a commercial approach which delivers viable options. Reach out today and start a conversation. Contact us for a free, no obligation discussion.  Email [email protected] or call us: 1 888-271-5063 (US toll free)    ♦   400-842 7017 (Beijing – toll free)   ♦    +61 2 9906 2984 (Sydney)

 

*Ferry in Fog Image by Keith Yahl, licensed under Creative Commons CC2 

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