Essentials of European Medical Device Regulatory Affairs - October 2019

Harmonized Standards • A harmonised standard is: • a European standard developed by a recognised European Standards Organisation: CEN, CENELEC, or ETSI. • Following a request from the European commission • Many are also ISO standards (EU deviations - Annex ZA) • Can be used to demonstrate that products, services, or processes comply with relevant EU legislation. • Use is voluntary • Presumption of compliance to relevant requirements of directive or the MDR • References of Harmonised Standards are published in the Official Journal of the European Union

https://ec.europa.eu/growth/single-market/europeanstandards/harmonised-standards_en

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Harmonized Standards Examples General Standards EN ISO 13485 Quality systems EN ISO 14971 Risk Management EN ISO 14155

Clinical Investigation of MDs for human subjects Good Clinical Practice

EN ISO 15223 -1

Symbols

EN 1041

Information supplied by the manufacturer

More Specific Standards EN ISO 10993 (series) Biological evaluation of medical devices EN 60601 (series) Medical Electrical safety EN ISO 11607 Product Specific Standards e.g. EN ISO 5840:2009 Cardiovascular implants - Cardiac valve prostheses Packaging Materials for devices to be sterilized

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