Obelis European Authorized Representative Center"CE Marking Consultants with a Reputation for Excellence"
The MDD 93/42/EEC amended by the 2007/47/EC consists of 22 Articles and 12 Annexes. The Articles define what a medical device is characterized according to the directive as well as the harmonized standards that the devices must meet. The Annexes list the general requirements to EC Verification.
Annex I- Lists and explains the essential requirements of the directive.
Annex II- Outlines the full quality assurance system or the EC Declaration of Conformity
Annex III-EC Type Examination outlined
Annex IV-Explains EC Verification
Annex V-EC Declaration of Conformity in reference to the production quality assurance
Annex VI-EC Declaration of Conformity in reference to device quality assurance
Annex VII-EC Declaration of Conformity process explained
Annex VIII-A statement concerning devices for special purposes
Annex IX-Classification criteria given
Annex X-Clinical Evaluation procedure documented
Annex XI-Criteria to be met for the designation of Notified Bodies
Annex XII-CE marking of conformity