From: [email protected] Subject: New Medical devices directive from EU
FYI: The IVDMDD has been published in the Official Journal. *Directive 98/79/EC of the European Parliament and of the Council of 27= October 1998 on in vitro diagnostic medical devices.* Published 7 December 1998 in OJ, volume 41, number L331 on pg 1-37. Adoption of national laws, regulations within EU/EEA: latest 7 December= 1999 Application of these laws (CE-marking, certificates, registration etc):= from 7 June 2000 Placing non-CE-marked IVDs on the market: up to 7 December 2003 Putting into service of these said IVDs (i.e. non-CE-marked and placed = on the market before 7 December 2003): up to 7 December 2005 The CE-marking above is in reference to the IVDMDD. Other national legislation (transposing EC Directives) containing CE-marking might be applicable before and/or after the dates stated above. Note: IVDMDD amends the following directives! -Machinery 89/392/EEC (no longer applicable to medical devices) -MDD 93/42/EEC (definitions, European databank, protection of health me= asures, withdrawal of certificates by Notified Bodies, *CE-marking of non-MDs*,= new deadline for devices already placed on the market but not yet put into = service, in-house competence of Notified Bodies) The directive is available in all 11 language versions and can be order= ed from your national sales offices for EU publications. New directives, commun= ications, court cases etc can also be down-loaded from the EUR-Lex /Celex /Eudor = databases via our web site. Eur-Lex, English version of IVDD (document is ONLY available on EUR-Lex= for 20 days after publication):=20 http://europa.eu.int/eur-lex/en/oj/index.html Information on how to obtain EU Directives and Harmonised Standards: http://europa.eu.int/comm/dg03/directs/dg3b/newapproa/eurstd/harmstds/w= hatsnew.h tml#textdir Eur-OP, global sales agents for EU publications: http://eur-op.eu.int/en/general/s-ad.htm Medical devices page: http://europa.eu.int/comm/dg03/directs/dg3d/d2/meddev/meddev.htm Some new approach Directives and their Harmonised Standards: http://europa.eu.int/comm/dg03/directs/dg3b/newapproa/eurstd/harmstds/r= eflist.ht ml Main EU web site : http://europa.eu.int =AB This a personal opinion =BB Bo Hojdefors European Commission DGIII /D2, medical devices [email protected] =
