In answer to your question regarding the "difference". Please see the last paragraph of Article 11, paragraph 2. It states that "Instead of applying these procedures, the manufacture may also follow the procedure referred to in paragraph 3 (a)." Paragraph 3(a) calls out Annex II with point 4 being not applicable.
Regarding your other question. Yes, if you remove point 4 from Annex II you end up with Annex V. The requirements of Annex VII are roughly equivalent to the requirements of point 4 of Annex II. NOTE in either case the manufacture must still do Annex VII or point 4 of Annex II. It is just that the notified body does not officially evaluate these parts of your compliance. If you would like to discuss this further, or have any other questions, please feel free to contact me. Ned Devine Medical Division TUV Product Service [email protected] Phone 1 612 638 0246 ------------- Original Text >From [email protected], on 06/05/1996 5:00 PM: To: <[email protected]> Cc: <[email protected]> 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, Beno CRIQ Centre de Recherche Industrielle du Qu Beno [email protected] Courtesy of RCIC http://uc.com/compliance_engineering/ The following was included as an attachement. Please use UUDECODE to retrieve it. 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