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
Directive codes: 93/68/EEC - MSD 2006/42/EC - TSD 2009/48/EC - CPR 305/2011/EU - ATEX 94/9/EC - MVD 2007/46/EC - 90/385/EEC - PED 97/23/EC - R&TTE 1999/5/EC - 2004/108/EC - PPE 89/686/EEC - LVD 2006/95/EC - 76/768/EEC - GPSD 2001/95/EC - IVDD 98/79/EC - MDD 93/42/EEC -
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