MEDIMARK EUROPE

The most important changes are the requirements of clinical data and design documentation for all classes of devices. It will particularly concern the manufacturers of class IIa devices because they are audited by a Notified Body. However, manufacturers of Class I devices are also concerned through their ISO 13485:2003 audit or when a competent authority makes an inspection of the technical files at the European authorized representative premises. Guidance documents and secondary legislation ought to be developed in order to ensure that the new provisions are adequately implemented but in March 2010 we have not seen much of these guidances.However, besides these main new requirements, the new medical device directive has introduced a lot of other changes which may impact your European business. MediMark Europe has performed an original work in creating a comprehensive glossary of these changes.