RegulaBase

LINK BASE

Medical devices regulations (EU)
EU Commission guidance documents concerning medical devices
MDCG - Medical Device Coordination Group - guidance documents (limited selection)
(web page)
MEDDEVs - EU Medical devices guidance documents
(web page)

2.1 Scope, field of application, definition

2.2 Essential requirements

2.4 Classification of Medical Devices

2.5 Conformity assessment procedure

2.7 Clinical investigation, clinical evaluation

2.10 Notified bodies

2.12 Post-Market surveillance

2.13 Transitional period

2.14 In-vitro Diagnostic (IVD) Medical Devices

2.15 Other guidance

Updated: December 31, 2020.

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