New MEDDEV document concerning classification of medical devices

EU-wide databank (EUDAMED) for medical devices to boost market surveillance

Issuance of Guidance on NB's Tasks of Technical documentation Assessment

New MEDDEV document concerning borderline products (drug delivery / medical devices)

Issuance of interpretative document of 2007/47/EC which amends the Medical Device Directive

New manual on borderline and classification for Medical Devices

Italian registration: deadline extended to December 31, 2009

Amended Directive available concerning Common Technical Specifications for IVD

Release of 2 new MEDDEV documents concerning clinical evaluation

Release of ISO-EN 1041:2008 Information supplied by the manufacturer of medical devices

Release of EN 980:2008 Symbols for use in the labelling of medical devices

REACH: Pre-registration has started 

European Commission launches its questionnaire on the next revision of the Medical Devices Directive 

New consolidated Medical Device Directive now available!!!

KEMA takes over certification activities for medical devices from TNO

NEW EU Regulation: REACH deals with the Registration, Evaluation, Authorisation and Restriction of Chemical Substances

GHTF final documents regarding clinical evaluation and clinical evidence

New Medical Device registrations procedures in Italy