Essentials of European Medical Device Regulatory Affairs - June 2020

Guidance Documents

http://ec.europa.eu/growth/sectors/medical-devices/guidance_en MEDDEVS for medical device directive.

medical device coordination group (MDCG)guidance is under development for the regulation.

TheOrganisation for Professionals in Regulatory Affairs

Other sources

Notified body (if you have one)

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• National Competent Authorities (CA) obliged to render decisions for any

individual product (if asked) - Note: opinions may differ

• MDCG Group: Borderline and Classification - CA and industry represented . - Provides a potential common position for Member States

- Note: US /Japan opinions on classification sometimes differ from EU - Manual on borderline and classification in the community regulatory framework for medical devices. https://ec.europa.eu/docsroom/documents/35582

• commission can introduce implementing acts to say if a specific product is a medical device, accessory, or not.

• European Court of Justice (“the Court”) the authoritative interpretation of Community law.

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Medical Devices Examples:- • Tongue depressors • Syringes • Dental fillings • Sutures • X-ray scanners • Blood bags • Prescription spectacles • Bandages • Wheelchairs • Artificial tears (unmedicated) • Hip replacements

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