The CE marking of MDs (Medical Devices) by the manufacturer or its agent is obligatory. Applicable since January 1995, the conformity of the manufactured MD is obligatory since 14 June 1998 and since 30 June 2001 only products physically marked CE can be put into service within the European Union.

The MD are classified in classes I, IIa, IIb or III.

A CE declaration of conformity must have been made for class I single-use products and, in order to bear the CE marking, the procedure specified in appendix VII of the directive must be followed. The class I sterile MDs (such as the gowns and the majority of surgical drapes) must have a certificate of conformity in relation to appendix V issued by a notified body that has verified the quality systems in place to guarantee the security of the products (in particular the sterilisation procedures).

For the class IIa products, the manufacturers generally comply with appendix II of the directive: complete quality assurance system without examination of the design which corresponds to EN 46001 including EN ISO 9001, standard replaced in 2003 by EN ISO 13485.They can also comply with appendix V : production quality assurance, which corresponds to EN 46002 including EN ISO 9002, standard replaced in 2003 by EN 13488.Other possibilities, but more rarely applied for this type of device: appendix IV (CE verification) or appendix VI (product quality assurance - EN 46003).

For class III products, a design examination, in conformity with appendix II.4 must be carried out by the notified body in addition to the procedure described for classes IIa.