Update to the Medical Device Directive - How does it affect you?
April 07 2010
The fifth amendment to the Medical Device Directive (2007/47/EC) went live on 21Mar10, amending the MDD (93/42/EEC) and AIMDD (90/385/EEC). Many of the changes were ‘housekeeping’ and minor changes however, several of the more major amendments could have serious impact on you and your company.
Revisions have been made to almost every one of the articles and annexes within the directive and are too numerous to list them all here, so we have listed some key points:
- Competent Authorities in each country where a clinical investigation is being conducted can now share information about a clinical investigation freely between other Competent Authorities. This means that if a clinical investigation is not permitted to run in a particular EU member state then all other participating Competent Authorities will be informed.
- A European Databank will be created by the EU commission before 05 September 2012 containing information on Medical Devices, manufacturers, authorised representatives and clinical investigations.
- Demonstration of conformity with the essential requirements must now include a clinical evaluation in accordance with annex X of the directive.
- All serious adverse events in a clinical investigation need to be reported to all Competent Authorities where the investigation is being performed.
- The manufacturer or AR must for a period of at least five years and in the case of implantable devices at least 15 years, after the last product has been manufactured, keep at the disposal of national authorities listed items of documentation.
As the deadline for all companies to be in full compliance with this new directive was 21 Mar 10, all companies should now be fully compliant. If you wish to further discuss the new directive and its potential implications for your Medical Device Company then please do not hesitate to contact the Medvance offices.