Did You Know?

Did you know that the European recast of the Medical Device Directives has been put on hold but the revision of the directives and new approach revision are coming?

There was frantic activity in Europe during May 2008 following the publication of a discussion document on the recast of the Medical Devices Directives that sparked a hot debate on the future of medical regulation in Europe. The recast did not reject the new approach but the European Commission are concerned--amongst many other items--about the consistency of notified body performance, market surveillance, and vigilance; however, these were also issues raised in the Revision of the Active Implantable Medical Device Directive (AIMDD) and Medical Devices Directive (MDD) that was only finalised during 2007 and is due to complete its transposition period by 21 March 2010. More controversial was the suggestion about putting more regulatory control into a central agency within the European Medicines Evaluation Agency (EMEA) and "...to create a specific Medical Device component of EMEA on an equal footing with medicinal products." This includes premarket approval of some of the highest risk devices and other suggestions included merging the AIMDD, MDD and two blood directives into one directive "...to consolidate all existing harmonisation measures..." and making ISO 13485: 2003 the conformity assessment procedure (as via Annex II MDD).

Companies interested in the future of non-viable human tissue engineered products, where the non-viable tissue has an ancillary rather than primary action, are particularly encouraged to monitor developments on the Recast as a majority of respondents wanted them to be regulated as devices rather than via the Advanced Therapies Regulation.

Whilst a majority of respondents to the consultation wanted to keep the invitro diagnostic (IVD) legislation separate from the other medical devices there was almost unanimous support for the classification of IVD medical devices to be changed to a rules-based risk classification system based on the Global Harmonisation Task Force (GHTF) guidance.

It is recommended that MasterControl clients interested in European medical products read the background and track further developments. 200 strong responses convinced the Commission to reconsider its position and the present Commissioner Gunter Verheugen has stated in the trade press that a re-draft of the Recast will be for his successor, i.e. after 2009. Given the modified New Approach, a revision of the framework of all New Approach Directives known as the New Approach Revision is now being implemented and will affect all directives by the 1st January 2010, that will be followed by the AIMDD/MDD Revision in March 2010 this is a pragmatic approach.

Please see www.medicaldeviceconsultancy.co.uk for more inforamtion in regard to the services provided by the Medical Device Consultancy.






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