Essentials of European Medical Device Regulatory Affairs

Classification of medical devices Conclusions Key points • Based on manufacturers’ intended purpose - Look at the product - Read the label - What are the ingredients and what is their function? • Medical device classification is risk-based and determined by the manufacturer’s intended use • Medical device manufacturer is responsible for compliance with the law as stated in the Declaration of Conformity • Many borderline areas to discuss with experts

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Module 4

• Conformity Assessment Process - Conformity assessment procedures - Risk Assessment - Technical Documentation - General Safety and Performance Requirements (GSPR) - Notified Body selection

- CE marking - Registration

The Organisationfor Professionals inRegulatory Affairs