Is MDD 93 42 EEC still valid?

According to article 120(2) of Regulation (EU) 2017/475 on Medical Devices (the MDR), certificates issued in accordance with Directive 93/42/EEC will remain valid until 27 May 2024 at the latest.

What is MDD Annex II?

Annex II (EC Declaration of Conformity – full quality assurance system) of Council Directive 93/42/EEC, a.k.a., the Medical Device Directive (MDD) delineates the regulatory requirements necessary for compliance with the Directive employing an acceptable quality assurance system.

What is MDD Annex V?

Annex V (EC Declaration of Conformity – Production Quality Assurance) of Council Directive 93/42/EEC, a.k.a., the Medical Device Directive (MDD) delineates the requirements for device manufacturers and their need to employ an approved quality system in support of manufacturing and inspection.

Is the EEC still valid?

It has applied since 29 June 1993 and had to become law in the EU countries by 1 July 1994. It will be repealed as from 26 May 2021.

What is CE MDD?

MDD/CE-marking In order to obtain medical device approval in the EU, medical devices must be correctly classified. The Medical Device Directive defines products into different classes, based on risk and intended use, which determine the relevant conformity assessment procedure in Annex IX.

What is the difference between EEC and EU?

The European Economic Community (EEC) was a regional organization that aimed to bring about economic integration among its member states. It was created by the Treaty of Rome of 1957. Upon the formation of the European Union in 1993, the EEC was incorporated into the EU and renamed the European Community (EC).

What countries are in EEC?

Austria, Belgium, Bulgaria, Croatia, Republic of Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain and Sweden.

What MDD means?

Depression (major depressive disorder)

What is MDD compliance?

The Medical Devices Directive (MDD) is an older regulatory requirement that was established in 1994. It applied to all devices sold on the European market, which means any device used inside Europe and sold within it is subject to these requirements.

What is the difference between MDD & MDR?

The MDD mentions the conduct of PMS and PMCF but provides no detailed requirements. The MDR provides requirements for a PMS system within the manufacturer’s QMS and the uses for the data gathered.