As reported several times, Directive 2007/47/EC which modifies the Medical Devices Directive 93/42/EEC became effective on March 21, 2010. From that day ALL manufacturers of medical devices must fulfill the new requirements. The changes require some modifications on the manufacturer's as well as Notified Body's side. In a worst-case scenario, certificates could be withdrawn. 

A short description of the main changes can be found here: Flyer - Directive 2007/47/EC.

We have summarized for you the important documents and links from our previous Newsletters:

• The text of the Directive 2007/47/EC can be found here.
• The consolidated text of the Directive 93/42/EEC with marked changes can be found here .
• NBOG document on technical examination assessment on a representative basis, which outlines the new approach resulting from Directive 2007/47/EC for certification procedures according to Annex II, V and VI for medical devices in risk classes IIa and IIb can be found here.
• Interpretative documents of the European Commission can be found here.

  Here you find Lists of consultants, who can help you with the implementation of the changes.