Essentials of European Medical Device Regulatory Affairs

Essential Requirements

General (as per Annex I) 1. Device to be designed and made to reduce risk when used as intended taking into account the intended users experience.* 2. effective risk management to include protective measures and information for the user 3. Must demonstrate performance 4. Must continue to meet performance throughout the product’s lifetime 5. Must be packed to survive shipment 6. Any undesirable side effects must constitute an acceptable risk when weighed against the performance intended. 6a. Must include a clinical evaluation*

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Essential Requirements

Requirements regarding Design and Construction

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7. Consider chemical, physical and biological properties 8. Infection and Microbial Contamination 9. Construction and Environmental Properties 10. Device with a Measuring Function 11.Protection against Radiation 12.Devices connected with an energy source 13. Information supplied by the manufacturer (see later)