Article 54 Understanding Clinical Evaluation Consultation Process

Sprache: Englisch

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.

Prior to his role at BSI, Richard worked as a clinical physiologist for 16 years within the National Health Service (NHS) specializing in implantable cardiac devices and electro physiology. Richard joined BSI in 2018 bringing his clinical expertise and passion for clinical data to the organization. Richard is also involved with the working groups of the Medical Device Co-ordination Group (MDCG) for the EU.

Sheila Walsh holds an Honours Degree in Biomedical Engineering from the University of Ulster.

Sheila started her career in the Medical Device Industry focusing on the manufacture of Cardiovascular devices and Catheter based technologies. After this, she moved into a Clinical Research based role, where she was responsible for the conduct of Clinical Studies in the areas of Ultrasound Imaging and prediction of Stroke risk.

Sheila joined BSI in 2007 and has held various Technical and Clinical review and leadership roles. In her current position she is responsible for providing Clinical Regulatory support to the Operational Teams.