RegulaBase

Medical devices regulatory LINK BASE

COVID-19 Regulatory

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European Commission (EC) Directives/Regulations
EC Guidance documents
MDCG - Medical Device Coordination Group (selection)
(source website)
Borderline and Classification
IMDRF - International Medical Device Regulators Forum
(source website)

IMDRF technical documents

IMDRF information documents 

MEDDEVs - EU Medical devices guidance documents
(source website)

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

FAQ

NB-MED DOCUMENTS

Updated: September 30, 2021.

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