The European Coordination Committee of the Radiological, Electromedical and Healthcare IT Industry (COCIR) has written an open letter to the European Commission and National Competent Authorities for Medical Devices over concerns surrounding a potential no-deal Brexit.
The letter criticises both the Commission and the remaining 27 European Union member states for not planning to adopt a specific transition period for medical devices.
The Medicines and Healthcare products Regulatory Agency (MHRA) has already published guidance for the UK in the event of a no-deal Brexit.
The major concerns listed in the letter are:
- UK Notified Bodies, which currently play a critical role in certifying medical devices placed on the EU27 market, will no longer be able to issue EU certificates.
- Non-EU manufacturers that currently have an Authorised Representative based in the UK will have to change to one based in the EU-27.
- Manufacturers transferring to a new – EU27-based - Notified Body will need to change how their devices are labelled to reflect the new Notified Body number or face non-compliance with the Medical Device Directives.
The letter reads: “We would like to point out that the current timing is insufficient to allow for manufacturers to receive certification by a new Notified Body. Even where a transfer is possible, and new CE certificates from EU-27 based Notified Bodies have only been issued in the last few weeks, re-labelling all their devices would be challenging at best and unfeasible in many cases, particularly for manufacturers with large product portfolios. If devices are not available, even temporarily, the resulting impact on European healthcare systems – and the safety of EU citizens - could be substantial.
“Therefore, in the best interest of citizens, we call on the European Commission, together with Member States, to agree on a limited transition period. This will allow those manufacturers directly impacted by any no-deal Brexit to continue to place devices certified by a UK Notified Body on the market.”