I think I agree with you after rereading Article 16. I may have missed the statement " They shall apply those provisions as from 20 July 2007". So I would change my interpretation to :
Today (or 20 days from when it was published in the OJ) : Compliance with the new directive begins for members states, in terms of changing their legislation to adopt the new version, they have until July 19th, 2007 to accomplish this. Manufacturers still comply with the old directive during this time. Reading it this way gives us 2.5 years for transition. ( I do wonder what would happen if manufacturers chose to comply sooner ............... in the past one could apply a new Directive either immediately or upon the first member state adopting it. Given the current wording, it appears the approach is to pick a firm date for transition). July 20 , 2007: Newly manufactured devices must comply with the new directive, as the old version is repealed. See Article 14. Already manufactured devices can be placed on the market until July 19, 2009 under the old directive (and put into service anytime, even after July 19, 2009). See Article 15. Article 15 must be interpreted with the knowledge of Article 14. July 20, 2009: Only devices compliant with the new directive allowed. What do others think ? Mike Hudon Philips Medical Systems Cardiac and Monitoring Systems Senior Manager Regulatory Affairs Tel: 978-659-3173 Fax: 978-659-4901 e-mail: [email protected] To: Mike Hudon/ANR/MS/PHILIPS@PHILIPS <[email protected]> cc: <[email protected]> <[email protected]> "Gert Gremmen" Subject: RE: New EMC directive <[email protected]> Classification: 01/04/2005 02:42 PM I do not fully agree with both of you Mike and John, The directive enters into force on Jan 20th of 2005 and the actual legal date of application would (for manufacturers) per member state depend on the actual date of implementation in national law. The target date of becoming into force is then 20-07-2007, when all national legislations must comply. Article 16 says clearly that member states should publish all regulations to make this legislation start per 2007. "they shall apply those provisions per 20-july-2007" The implementation of directive 89/336/EC was similarly announced in 1989 and came into force 6 months after the legislation target date of July 1992, being 1-1-1992 The grace period was 4 years here, but was added later. For NON-EC manufacturers: the need for a REP remains also until July 2007. Fixed Installations: remain a big problem Some of the new requirements: -Both EC DoC AND Technical documentation must remain at the disposition of the authorities (now: only DoC) -All apparatuses need to clearly indicate the manufacturer or responsible person. -All states of operation need to be considered. -An assessment need to be made regarding the protection requirements in the view of the essential requirements. Harmonised standards application will be equivalent to this assessment. (this has been a point of discussion, as some standards still do not cover all phenomena; but look at the order of presentation. legally equivalent means : the same in value, meaning) Point 3 of annex II however, says that in addition to the assessment the technical documentation need to give evidence of compliance with the essential requirements. This is a backdoor entry to get back the phenomena not correctly covered by harmonised standards. And finally point 8 annex II adds to the current situation that manufacturers need to take all measures to ensure that the design AND manufacture complies with the technical documentation that enables the assessment of compliance to the essential requirements and GIVES EVIDENCE of compliance to harmonised standards. New here is the manufacturing part and the stronger expression "GIVES EVIDENCE" . Possibly some other phrases will give rise to additional conclusions to be drawn. Regards, Gert Gremmen Approvals manager ====================================================== ce-test, qualified testing Member of EMC committee CENELEC/IEC + Independent Consultancy Services + Compliance Testing and Design for CE + Improvement of product quality and reliability + Testing services according to: Electro magnetic Compatibility 89/336/EC Electrical Safety 73/23/EC Medical Devices 93/42/EC Radio & Telecommunication Terminal equipment 99/5/EC Website: www.ce-test.nl Phone : +31 10 415 24 26 Fax : +31 10 415 49 53 ====================================================== FW>-----Original Message----- FW>From: [email protected] [mailto:owner-emc- FW>[email protected]] On Behalf Of [email protected] FW>Sent: dinsdag 4 januari 2005 18:19 FW>To: [email protected] FW>Cc: [email protected]; [email protected] FW>Subject: RE: New EMC directive FW> FW>I agree this is confusing, how would you apply Article 14 ? It says From FW>July 20th on the old directive is repealed, therefore it cannot be FW>applied FW>any longer to newly manufactured devices. FW> FW> FW>The only way Article 14 and 15 can work together (at least in my mind) is FW>Article 15 applies to inventory. I read Article 15 as a 2 year grace FW>period FW>to continue to sell inventory produced prior to July 20, 2007. In our FW>world (Medical Devices) we have to keep manufacturing records, so it may FW>make more sense to us. I don't know what the IT world requires. If FW>manufacturing dates are not recorded it may be a mute point. FW> FW> FW> FW>Mike Hudon FW>Philips Medical Systems FW>Cardiac and Monitoring Systems FW>Senior Manager Regulatory Affairs FW>Tel: 978-659-3173 FW>Fax: 978-659-4901 FW>e-mail: [email protected] FW> FW> FW> FW> FW> FW> To: emc- FW>[email protected] FW> cc: (bcc: Mike FW>Hudon/ANR/MS/PHILIPS) FW> Subject: RE: FW>New EMC directive FW> FW> [email protected] Classification: FW> FW> Sent by: FW> [email protected] FW> .ORG FW> FW> 01/04/2005 11:45 AM FW> FW> FW> FW> FW> FW>Article 15 clearly states that placing on the market or putting into FW>service of equipment which FW>in compliance with the existing EMC Directive shall not be impeded until FW>20 FW>July 2009. FW> FW>> Already manufactured devices can be placed on the market until July 19, FW>2009 under FW>the old directive (and put into service anytime, even after July 19, 2009 FW> FW>I do not believe that is correct. Am I missing something? FW> FW>John Radomski FW>Principal Engineer FW>Schneider Automation FW> FW> FW> FW> FW> FW> [email protected] FW> m To: FW><[email protected]> FW> Sent by: cc: FW>[email protected], [email protected] FW> owner-emc-pstc@LISTSE Subject: RE: New EMC FW>directive FW> RV.IEEE.ORG FW> FW> FW> 01/04/2005 10:57 AM FW> FW> FW> FW> FW> FW> FW>Here is my interpretation: FW> FW>Today (or 20 days from when it was published in the OJ) : Compliance with FW>either directive is permissible. See Article 17. FW> FW>July 20 , 2007: Newly manufactured devices must comply with the new FW>directive, as the old version is repealed. See Article 14. Already FW>manufactured devices can be placed on the market until July 19, 2009 FW>under FW>the old directive (and put into service anytime, even after July 19, FW>2009). FW>See Article 15. Article 15 must be interpreted with the knowledge of FW>Article 14. FW> FW>July 20, 2009: Only devices compliant with the new directive allowed. FW> FW>My understanding is that the Directive applies to each individual device FW>manufactured and not a particular design, thus the dates apply to the FW>manufacturing of devices. FW> FW> FW>Mike Hudon FW>Philips Medical Systems FW>Cardiac and Monitoring Systems FW>Senior Manager Regulatory Affairs FW>Tel: 978-659-3173 FW>Fax: 978-659-4901 FW>e-mail: [email protected] FW> FW> FW> FW> FW> FW> To: FW><[email protected]> FW> cc: (bcc: Mike FW>Hudon/ANR/MS/PHILIPS) FW> Subject: RE: FW>New FW>EMC directive FW> FW> <[email protected]> Classification: FW> FW> Sent by: FW> [email protected] FW> .ORG FW> FW> 01/04/2005 09:24 AM FW> FW> FW> FW> FW> FW>Before July 20, 2007 you need to use the 89/336/EEC. FW>>From that until 20 July 2009, both are allowed. FW>For products that leave you factory after July 20, 2009 the DoC needs to FW>be FW>updated to read 2004/108/EC. FW> FW>There is a plan to make an interpretation document, similar that was done FW>for 89/336. FW> FW>regards, FW>Ari FW> FW> FW> FW>> -----Original Message----- FW>> From: [email protected] FW>> [mailto:[email protected]] On Behalf Of FW>> [email protected] FW>> Sent: 04 January 2005 13:01 FW>> To: [email protected] FW>> Cc: [email protected]; [email protected] FW>> Subject: Re: New EMC directive FW>> FW>> Does this mean that you can use either EMC Directive until 20 FW>> July 2009? FW>> FW>> Bob Heller FW>> 3M EMC Laboratory, 76-1-01 FW>> St. Paul, MN 55107-1208 FW>> Tel: 651- 778-6336 FW>> Fax: 651-778-6252 FW>> ============================================================== FW>> ========== FW>> ==================== FW>> FW>> FW>> FW>> <amund@westin-emi FW>> ssion.no> FW>> Sent by: FW>> To FW>> owner-emc-pstc@LI <[email protected]> FW>> STSERV.IEEE.ORG FW>> cc FW>> FW>> FW>> Subject FW>> 01/03/2005 04:20 New EMC directive FW>> PM FW>> FW>> FW>> FW>> FW>> FW>> FW>> FW>> FW>> FW>> The new European Union EMC directive was published in the Official FW>> Journal FW>> on 31 December 2004. FW>> FW>> Check it out here FW>> http://europa.eu.int/eur-lex/lex/LexUriServ/site/en/oj/2004/l_ FW>> 390/l_3902 FW>> 0041 FW>> FW>> 231en00240037.pdf FW>> FW>> Best regards FW>> Amund Westin, Oslo / Norway FW>> FW>> ---------------------------------------------------------------- FW>> FW>> ---------------------------------------------------------------- FW>> This message is from the IEEE Product Safety Engineering Society FW>> emc-pstc discussion list. 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