European Commission Requirements for Marketing Medical Devices in a No-deal Brexit Scenario
Regulatory Updates | In-Vitro Diagnostic Devices, Medical Devices, Procurement/Supply Chain
EMERGO BY UL SUMMARY OF KEY POINTS:
- Definition of “placing on the market” linked to economical ownership;
- Economical ownership only counts for goods already produced;
- CE Mark certificates of UK-based Notified Bodies will become void after Brexit day;
- No exceptions made for medical devices when it comes to certificates.
The European Commission speaks
The European Commission has published new recommendations in Q&A format for obtaining CE Mark certification and placing industrial products including medical devices on the European market in the event of a no-deal Brexit.
On January22, 2018 the European Commission published a Notice to Stakeholders regarding the withdrawal of the UK from the European Union (EU) (i.e., Brexit). The notice made clear that Brexit would have a significant impact on access to medical devices manufactured, imported and/or certified in the UK to the Single Market. More recently, on February 1, 2019 the European Commission has issued a Q&A document regarding the certification and placing on the market of industrial products. This document is only applicable if a no-deal Brexit situation comes to pass, in which case there will be no (transitional) arrangements. Unless the UK accepts an agreement with the EU, this will happen at midnight on March 29, 2019.
The concept of “placing on the market”
It is important to fully understand what is meant by “placing on the market” in order to know what products can be legally distributed and used in the EU after Brexit. First, it is important to understand that this concept refers to each individual product and not to types of products. This means that two shipments of identical products will each be considered individually.
The second important point is about ownership. If a product has been sold, the location of the new owner will determine whether the product has been placed on the EU market. For example, if a UK-based manufacturer sells a product to an EU-based distributor before Brexit day, the device will considered to be placed on the EU market--even if the product is delivered after that date.
The third point of relevance is the date on which the product is physically produced. This means that a UK manufacturer can only supply products that existed before Brexit day to EU distributors or users; after that day, British manufacturers may supply their products only under the current Single Market rules.
Of course it would still be possible for UK-based companies (manufacturers or otherwise) to deliver products to the EU market. In that case these supplies will be considered imports from outside the EU and (among other requirements) an importer as well as an Authorized Representative must be used and referred to in the information accompanying the device.
CE Certificates and Notified Bodies
UK-based Notified Bodies (NBs) will no longer be recognized by the EU. They can no longer issue or maintain certificates. Products requiring EU-certification can only be placed on the EU market with valid certificates. This means that after Brexit day, manufacturers of these products must have valid CE certificates issued by an EU27-based NB, and their Declarations of Conformity must reflect that certification.
No exceptions for medical devices
It is clear what the European Commission wants to illustrate: access to the Single Market is a privilege for a specific group of countries, which comes at a price. They do not allow for a free ride.
This position means that after Brexit, certain products may no longer be available for EU citizens, or only at a higher price. In case of a specific brand of deodorant, for example, a disappointed consumer may be offered an alternative quickly. But in case of medical devices, no availability may have life threatening consequences. This may not be limited to the use of that particular device; some devices are used together with other devices. Lack of supply of a single device can have trickle-down effects in healthcare systems and potentially impact an entire hospital system.
Emergo by UL has been informed by sources at the Dutch Ministry of Health that the European Commission will not make exceptions for medical devices regarding their placing on the market. It is questionable if this position is in the best benefit for EU citizens.
Does this answer all question?
This Q&A document answers many and probably the most urgent questions regarding the placing on the market of products around Brexit day. But some points are still open. For example:
- What about software?
- What will count as the date of production in cases where the software is just a fully identical copy?
- What if a user has bought software that is periodically updated?
- What about the supply of spare parts for devices that are individually CE Marked?
There may be more open questions. The medical device community should work together and make sure these questions reach the European Commission. There is a big role for medical device and healthcare industry stakeholders’ organizations in this outcome.
Ronald Boumans is Senior Global Regulatory Consultant at Emergo by UL in The Netherlands.
Additional European and UK medical device regulatory resources: