Bonjour, I just finished to read the European Medical Directive (93/42/CEE) and I noticed a diiference in the procedure to demontrate conformity of Class IIa medical equipemnt in two sections of the directive.
Article 11, point 2 states that Class IIa equipements have to demons- trate conformity using appendix VII in conjunction with appendix IV or appendix V or appendix VI. But in appendix II, point 7 states that appendix II can apply to Class IIa equipment without point 4 of the same appendix. Does these two statements say the same thing (point 4 of appendix II deals with the design of the product, if you remove it do you fall on appendix V requirements ?) Your comments will be appreciated, Benoît Nadeau, P.eng. CRIQ Centre de Recherche Industrielle du Québec Benoît Nadeau [email protected] Courtesy of RCIC http://uc.com/compliance_engineering/
