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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).
Head of Clinical Compliance, BSI
Clinical Regulatory Lead, Clinical Compliance Team, BSI
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