Manufacturers of medical devices had in general a transition time of 3 years to meet the requirements of the MDR. However, certificates issued under the former Directives can only remain valid until maximum 27 May 2024.
This session will address the following:
- In practice, how do manufacturers keep certificates valid during the extended transition time?
- How can manufacturers make the grace period a success and take full advantage of it; what are the pitfalls?
- What will notified bodies be focusing on, e.g. during audits, technical documentation reviews?
- Which guidance do notified bodies still need from Regulators?
- Is there still a notified body capacity issue?
- Assessing different Notified Body interpretations: how can we ensure a harmonised approach?
- Understanding Notified Body priorities for MDR implementation