Brexit FAQ: Regulation of medical devices
Be prepared for Brexit: The questions you need to ask
Life sciences companies with operations in the UK or Europe are wondering where to even start when it comes to Brexit-related legal issues.
To give you a jumpstart, our colleagues from different practice groups across multiple countries have prepared a series of questions you should ask to better understand how Brexit will impact your business and to clarify what steps need to be taken. In this edition, we discuss questions related to the regulation of medical devices.
Regulation of medical devices
For non-EU manufacturers:
- How many of your devices are marketed in the EU with an appointed UK Authorised Representative?
For legal manufacturers established in the UK:
- Have you identified an experienced Authorised Representative established within an EU Member State which could serve as your local representative?
- How many of your devices would require an update of the labelling, outer packages and Instructions for use in order to include the details of an Authorised Representative and benefit from access to EU markets?
- How many of your devices will need to be re-registered as a result of the appointment of a new Authorised Representative?
- Will you be required to comply with the new Medical Device Regulations?
For all medical device manufacturers:
- How many of your devices rely on CE Certificates of Conformity granted by a UK notified body?