What is MDD certificate?
What is MDD certificate?
SHARE: The Medical Devices Directive (MDD) applies to all general medical devices not covered by the Active Implantable Medical Devices Directive or the In vitro Diagnostic Medical Devices Directive. In order to obtain medical device approval in the EU, medical devices must be correctly classified.
What is CE MDD?
For products classified with medium to high degree of risk (class Is, Im, IIa, IIb and III) the Medical Device Directive requires a conformity assessment procedure involving a notified body. …
When did MDD come into force?
The Directive was most recently reviewed and amended by the 2007/47/EC and a number of changes were made. Compliance with the revised directive became mandatory on 21 March 2010.
What is Article 12 of the MDD 93/42/EEC?
Article 12 of the Medical Devices Directive (MDD) 93/42/EEC defines the conformity assessment necessary to configure individual medical devices into a system and to ensure safety when putting these systems into service and during use. For Article 12 to apply, each individual medical device that makes up a system must bear its own CE marking.
What does MDD 93/42 stand for?
Article 12 of the Medical Devices Directive (MDD) 93/42/EEC defines the conformity assessment necessary to configure individual medical devices into a system and to ensure safety when putting these systems into service and during use. For Article 12 to apply, each individual medical device that makes up a system must bear its…
What is the EEC 93/42 Directive on medical devices?
COUNCIL DIRECTIVE 93/42/EEC of 14 June 1993 concerning medical devices THE COUNCIL OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European Economic Community, and in particular Article 100a thereof, Having regard to the proposal from the Commission (1), In cooperation with the European Parliament (2),
What is the EEC 93/42/EEC?
COUNCIL DIRECTIVE 93/42/EEC of 14 June 1993 concerning medical devices THE COUNCIL OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European Economic Community, and in particular Article 100a thereof, Having regard to the proposal from the Commission (1),
