Module 14 2022

22/03/2022

WHY is Certification required?

To market a medical device in the EU • You NEED A CE MARK In accordance with • MDD (e.g. 93/42/EEC) /Medical Device Regulation (2017/745): Basis for CE Marking • EC Declaration of Conformity Conformity with General Safety and Performance Requirements; (formerly the Essential Requirements) for Medical Devices

Masterclass Lecture 8

The Organisation for Professionals in Regulatory Affairs

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How is CE Certification Achieved?

SELF CERTIFICATION • Most Class I Devices

• Preparation of STED • Sign Declaration of Conformity, affix CE mark • Notification to Regulatory Agency of placing Device on the Market CERTIFICATION BY A NOTIFIED BODY • Class II, III Devices (and class I sterile, measuring or reusable) • Preparation of STED • Assessment by Notified Body • Granting of CE Mark

Masterclass Lecture 8

The Organisation for Professionals in Regulatory Affairs

4

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