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 role and responsibilities
• How the UK manufacturer can transition Brexit by engaging a Notified Body and Authorised Representative based in mainland EU
And of course, what happens if a UK Manufacturer only wants to sell in the UK with no CE mark?
This seminar will include a group discussion, review and Q&A session.
Seminar Keynote: John Adcock, Managing Director, Advena Ltd
Advena Ltd, are a team of experienced consultants, based in Warwick, who have recently passed their 20 year anniversary for assisting medical device manufacturers globally. For more information please visit: www.advenamedical.com
This seminar is FREE to all Medilink Members. Non-members are welcome to attend at a rate of £20 + VAT.
For further information or to register your place, please click here.