obelis logo

Obelis European Authorized Representative Center

"CE Marking Consultants with a Reputation for Excellence"


You are here:

Structure of the MDD 93/42/EEC

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

MDD 93/42/EEC | Structure | Scope | Compliance | Custom made devices | Kits | Amendment 2007/47/EC | Clinical Investigation of the MDD 93/42/EEC | MDD 93/42/EEC Services

obelis people image

Client Access

Old system login



New system login

Search


International Markets






GiDoS - Green Regulatory Center

Our sister company GiDoS s.p.r.l. provides REACH, WEEE, RoHS and P&PW compliance services.
Visit GiDoS.net

Newsletter

» Sign up for our newsletter to receive our weekly publications on EU directives, our news and events, as well as updates to our web site.

Follow us:

           

Career Opportunities