RegulaBase

Medical devices regulatory LINK BASE

European Commission (EC) Directives/Regulations
EC Guidance documents
EC Coronavirus updates
MDCG - Medical Device Coordination Group (selection)
(source website)
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: April 30, 2021.

error: