Dear colleague within Regulatory Affairs and Standardisation,
For your information! *New harmonised European standards in relation to EU:s medical devices directives AIMDD, MDD and IVDD: Published in O.J. as C227 on 10 August 1999, pgs 15-18. 3 lists published as: 1999/C 227/07 1999/C 227/08 1999/C 227/09 Can be obtained in PDFormat in all language versions from the EUR-Lex service. English version of C227 at: http://europa.eu.int/eur-lex/en/oj/1999/c_22719990810en.html Pls note that the second part of C227/09 is missing from the current link to C227/09. The full document C227/09 is, however, obtainable as C227/10 , i.e. click on the next item in the list. Further, two new consolidated lists have been published under AIMDD and MDD. Published in O.J. as C181 on 26 June, 1999: 1999/C 181/02 1999/C 181/03 As before, all harmonised standards are listed on the EU Commissions DGIII page: http://europa.eu.int/comm/dg03/directs/dg3b/newapproa/eurstd/harmstds/reflis t.html * Directive on in vitro diagnostic medical devices (IVDMDD or IVDD) as well as other directives, all language versions, is obtainable in full text! Apart from giving retrieve possibility for the some 45 days of Official Journal, EUR-Lex service now also gives you legislation in force, older volumes of OJ and preparatory acts searchable by NUMBER. Hereby you can download the text (but not figures like the CE marking) of AIMDD, MDD, IVD. Search engine, search by plain text and by number, located at: http://europa.eu.int/eur-lex/en/search.html For example, the English IVDD you will find at: http://europa.eu.int/eur-lex/en/lif/dat/1998/en_398L0079.html Corrigendum to the IVDMDD Corrigendum to the English and Swedish versions of Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices (OJ L 331 of 7.12.1998). OJ L 22 of 29.1.1999, page 75 (not yet on the Europa-DGIII-web pages) * The directive on active implantable medical devices (AIMDD) as well as the directive on (*common*) medical devices (MDD) can also be down loaded from EUR-Lex above. The English versions are also located at: http://europa.eu.int/comm/dg03/directs/dg3d/d2/meddev/meddev.htm Note re. the MDD down loaded from the EUR-Lex service: Annex XI and XII are missing from the Finnish and Swedish versions of MDD. * Last, but not least, what the mfr. have to comply with can be found in the list of national regulations implementing the various Directives: http://europa.eu.int/scadplus/leg/en/m06000.htm Bo Hojdefors Principal Administrative Officer, Medical Devices Expert sent from: [email protected] --------- This message is coming from the emc-pstc discussion list. To cancel your subscription, send mail to [email protected] with the single line: "unsubscribe emc-pstc" (without the quotes). For help, send mail to [email protected], [email protected], [email protected], or [email protected] (the list administrators).
