BREXIT: the implications on CE marking Medical Devices
13:00 PM - 15:30 PM
This seminar will be a short review of the current status of Brexit and how it may affect those manufacturers who wish to apply the CE mark to their devices post Brexit.
Covered topics will include:
- Brexit – the implications on CE marking medical devices
- How Notified Bodies are handling the situation
- How registrations for lower class devices could be affected
- The need for an Authorised Representative and how it works for non-EU manufacturers now
- What an Authorised Representative does and their responsibilities
- How the new EU MDR and IVDR affect the Authorised Representative’s roll and responsibilities
- How the UK manufacturer can transition Brexit by engaging a Notified Body and Authorised Representative based in mainland EU.
The four pillars set out by ABHI provide a foundation that underpins the prosperity of the medical technology industry in its role of supporting the NHS, and I look forward to working with ABHILord Phillip Hunt (Opposition front-bench spokesman on health, House of Lords )