In the R&TTE, under the conformity assessment procedure for internal production control (which is for the self declaration route) states
"3. Where neither the manufacturer nor his authorised representative is established within the Community, the obligation to keep the technical documentation available is the responsibility of the person who places the product on the Community market" I interpreted this to be that the techinical documenation (not the "TCF") needs to be in the Community. However, conformity assessement for the "TCF" route with a notified body states "The manufacturer or his authorised representative established within the Community or the person responsible for placing the apparatus on the market must keep the file for a period ending at least 10 years after the last apparatus has been manufactured at the dsposal of the relevant national authorities of any Member States for inspection" There is no condition as whether the manufacturer must reside within the Community. I assume because the notified body is essentially maintaining it. It appears (of course I will have to read it several more times) that the location of the technical documentation(whether in the form of a "formal" tcf or a praf (courtesy of John Allen)) depends upon the confomity assessment procedure used. I have not gone back to the EMC or LVD directive to check this. I would be nice if all the directives where consistent in terminology as well as the documentation process. jim stafford carrier access corp. -----Original Message----- From: Dick Grobner [mailto:[email protected]] Sent: Thursday, March 02, 2000 8:58 AM To: 'Stafford, Jim' Cc: '[email protected]' Subject: RE: Technical Documentation Within the Medical Device Directive, 93/42/EEC, Annex VII it states as: "The manufacturer must prepare the technical documentation described in Section 3 (TDF). The manufacturer or his authorized representative established within the community must make this documentation, including the declaration of conformity, available to the national authorities for inspection purposes for a period ending at least five years after the last product has been manufactured." It seems it can be either one. However - our Authorized Representative has requested a copy of our technical documentation file and we obliged. There is also a similar requirement in Article 10 of the EMC Directive 89/336/EEC. Hope this helps. -----Original Message----- From: Stafford, Jim [mailto:[email protected]] Sent: Wednesday, March 01, 2000 1:50 PM To: IEEE EMC BB Subject: RE: Techinical Documentation a couple of questions to round out this thread. Let me start off with definitions TCF : document for "type" approval by competent body Technical documentation file (TDF): manufacturer's documentation that show conformity with essential requirements. 1) Can either of the these files mentioned above (which depends upon the certification route) be held by a foreign manufacturer (non-EC member) or do they need to be held within the community by authorized representative? 2) Does this vary depending upon the directive(s) to which conformity is being shown? jim stafford carrier access corporation [email protected] ------------------------------------------- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. To cancel your subscription, send mail to: [email protected] with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Jim Bacher: [email protected] Michael Garretson: [email protected] For policy questions, send mail to: Richard Nute: [email protected] ------------------------------------------- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. To cancel your subscription, send mail to: [email protected] with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Jim Bacher: [email protected] Michael Garretson: [email protected] For policy questions, send mail to: Richard Nute: [email protected]
