Essentials of European Medical Device Regulatory Affairs - October 2019

Other Guidance

• Notified body (if you have one) • National Competent Authorities (CA) obliged to render decisions for any individual product (if asked) - Note: European opinion may differ • Borderline and Classification Medical Devices Expert Group - CA and industry represented . - MDEG can help with an opinion - Guidelines, not legally binding - Provides a potential common position for Member States - Note: US /Japan opinions on classification sometimes differ • 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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