Essentials of European Medical Device Regulatory Affairs

Guidelines -MEDDEVs

2.1 Scope, field of application, definition (6) 2.2 Essential requirements (2) 2.4 Classification of Medical devices 2.5 Conformity assessment procedure - General rules (5) - 2.7 Clinical investigation, clinical evaluation (5) 2.10 Notified bodies (1 + 4 annexes) 2.11 Products using materials of biological origin 2.12 Market surveillance (2) 2.13 Transitional period (2) 2.14 IVD (4) 2.15 Other guidance (1 on working groups)

Conformity assessment for particular groups of products (3)

http://ec.europa.eu/growth/sectors/medical‐devices/guidance_en

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Harmonized Standards

• A harmonised standard is a European standard developed by a recognised European Standards Organisation: CEN, CENELEC, or ETSI. • Medical device arena is very broad - thousands of products, need to be grouped • Developed by consensus: • Created following a request from the European Commission to one of these organisations. • Manufacturers, other economic operators, or conformity assessment bodies can use harmonised standards to demonstrate that products, services, or processes comply with relevant EU legislation. • The references of harmonised standards must be published in the Official Journal of the European Union. • Use of standards to demonstrate compliance to essential requirements is voluntary • Where used, notified bodies presume compliance to directive • Standards are listed in the Official Journal of the European Union https://ec.europa.eu/growth/single-market/european- standards/harmonised-standards_en

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