Essentials of European Medical Device Regulatory Affairs - June 2020

Chapter II

Articles 5-24

Making available on the market and putting into service of device, obligations of economic operators, reprocessing, CE marking and free movement

• To put a producton the market you need to conform to

Annex I

General safety and performance requirements

(GSPR)

• You must not make misleading claims

• Devices in conformity with commonspecifications shall be presumed to be compliant with the regulation

• Devices in conformity with standards shall be presumed to be compliant with the regulation

TheOrganisation for Professionals in Regulatory Affairs

Harmonized Standards

• A harmonised standard is: • a Europeanstandarddevelopedbya recognisedEuropeanStandardsOrganisation:CEN, CENELEC,or ETSI. • Following a request from theEuropeancommission • 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/european-standards/harmonised-standards/

TheOrganisation for Professionals in Regulatory Affairs

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Harmonized Standards Examples

General Standards EN ISO 13485

Quality systems Risk Management

EN ISO 14971 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

Packaging Materials for devices to be sterilized

Product Specific Standards e.g. EN ISO 5840:2009 Cardiovascular implants - Cardiac valve prostheses

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