Overview

BSI Medical Devices webinar provides 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.

Key takeaways and learning objectives

This webinar will cover: 

• Introduction to the EU Expert Panels

• Article 54

• The CECP Process

• Preparing your submissions

• Article 54.3

• Article 61 (2)

• BSI experience of CECP

Presenter information

Speakers - Richard Holborow/Sheila Walsh, Head of Clinical Compliance/Clinical Regulatory Lead