What’s this webinar about?
This webinar will provide the required information to manufacturers of class III implantable, and class IIb active rule 12 administer or remove medicinal substances (ARMS) devices of the new clinical evaluation consultation procedure (CECP) in accordance with Article 54 of the Medical Device Regulations EU 2017/745.
The Webinar will cover the following points:
- MDR Requirements in relation to Article 54
- Examples of devices and modifications to devices that may trigger the CECP Process
- Overview of the Process and documentation submitted to the expert panel process
- Overview of The Expert Panels at EMA
- Criteria of the Expert Panels that trigger an opinion including novelty.
- The steps and actions involved if an opinion is published
- Article 61 (2) Clinical Strategy Discussions with the Expert Panels
What will participants gain?
Participants will gain an understanding of:
- The CECP Process
- When a notified body will forward a review for an opinion from the expert panels
- The process and timescales associated with the opinion
- Whether their MDR application is eligible for CECP and whether it will trigger an opinion
- BSI experience of the CECP process to date.
Who should attend?
Manufacturers of class III implantable, and class IIb active rule 12 administer or remove medicinal substances (ARMS) devices.