Article 54 Understanding the Clinical Evaluation Consultation Process

This webinar will provide the required information to manufacturers in accordance with Article 54 of the Medical Device Regulations EU 2017/745.

Article 54 (1) outlines the classifications of devices that are potential subject to CECP.
What triggers CECP for a legacy device.
The CECP process - considerations of submitted documentation.
Article 54.3 & Article 61 (2).

Class III implantable, class IIb active rule 12 administer or ARMS devices.

Information to manufacturers of class III implantable, and class IIb active rule 12 administer or remove medicinal substances (ARMS) devices.

Speaker

Head of Clinical Compliance, BSI

Speaker

Clinical Regulatory Lead, Clinical Compliance Team, BSI

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