Hi Neil, Thanks for your response. Let me see if I can clarify. The product we are talking about is Class 1 device. We have offices and service centers in the UK, Germany and France. In addition to this we use a network of distributors. These distributors for this device in question are medical device distributors. Currently we manufacture product here in the US but that could change in the future. To date we have product that fall into ITE, Laboratory equipment and Medical categories. We currently have DOC for this device in question and it conforms with the MDD. According to Article 14, COUNCIL DIRECTIVE 93/42/EEC it indicates informing the competent authorities in that member state. Thus my confusion, I did not concern myself with this issue until recently, when the question was asked, "Are there any requirements for European Distributors of Medical Devices" . Article 14 Article 14 Registration of persons responsible for placing devices on the market 1. Any manufacturer who, under his own name, places devices on the market in accordance with the procedures referred to in Article 11 (5) and (6) and any other natural or legal person engaged in the activities referred to in Article 12 shall inform the competent authorities of the Member State in which he has his registered place of business of the address of the registered place of business and the description of the devices concerned. 2. Where a manufacturer who places devices referred to in paragraph 1 on the market under his own name does not have a registered place of business in a Member State, he shall designate the person(s) responsible for marketing them who is (are) established in the Community. These persons shall inform the competent authorities of the Member State in which they have their registered place of business of the address of the registered place of business and the category of devices concerned. 3. The Member States shall on request inform the other Member States and the Commission of the details referred to in paragraphs 1 and 2. Thank you,
Mark Schmidt Regulatory Compliance X-Rite Incorporated Grandville, MI USA (616) 257 2469 mschm...@xrite.com -----Original Message----- From: Barker, Neil [mailto:neil.bar...@e2vtechnologies.com] Sent: Wednesday, September 18, 2002 11:29 AM To: Mark Schmidt; emc-p...@majordomo.ieee.org Subject: RE: Distributors of Medical Devices in Europe << File: Neil R. Barker (E-mail).vcf >> In general a Class 1 Medical Device requires only a manufacturer's Declaration of Conformity before it is placed on the market. However, in the context of the Medical Devices Directive the manufacturer is not the person or entity who makes the product but the person or entity who places the product on the EU market in their own name. Hence a manufacturer can be one person in an office who contracts with others to design and manufacture a product which is then placed on the market under a label, "Brand X", that belongs to the one-person company. It is the responsibility of that one-person company to issue the Declaration of Conformity, and it is their responsibility to ensure that all the requirements of the MDD are met. In the case of Distributors, it is the responsibility of the original importer into the EU, but not of further distibution thereafter. It is worth reading the Directive itself. It is not that large a document and is quite readable. Best regards, Neil R. Barker Compliance Engineering Manager E2V Technologies Waterhouse Lane Chelmsford Essex CM1 2QU U.K. Tel: +44 (01245) 453616 Fax: +44 (01245) 453410 E-mail: neil.bar...@e2vtechnologies.com > -----Original Message----- > From: Mark Schmidt [mailto:mschm...@xrite.com] > Sent: 18 September 2002 13:11 > To: emc-p...@majordomo.ieee.org > Subject: Distributors of Medical Devices in Europe > > > > Hello Group, > > Are there any requirements for European Distributors of > Medical Devices, i.e. license or registration. The Device in > question is a Class 1 device. > > Thank you. > > Mark Schmidt > Regulatory Compliance > X-Rite Incorporated > Grandville, MI > USA > (616) 257 2469 > mschm...@xrite.com > ------------------------------------------- > This message is from the IEEE EMC Society Product Safety > Technical Committee emc-pstc discussion list. > > Visit our web site at: http://www.ewh.ieee.org/soc/emcs/pstc/ > > To cancel your subscription, send mail to: > majord...@ieee.org > with the single line: > unsubscribe emc-pstc > > For help, send mail to the list administrators: > Ron Pickard: emc-p...@hypercom.com > Dave Heald: davehe...@attbi.com > > For policy questions, send mail to: > Richard Nute: ri...@ieee.org > Jim Bacher: j.bac...@ieee.org > > All emc-pstc postings are archived and searchable on the web at: > http://ieeepstc.mindcruiser.com/ > Click on "browse" and then "emc-pstc mailing list" > ------------------------------------------- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. Visit our web site at: http://www.ewh.ieee.org/soc/emcs/pstc/ To cancel your subscription, send mail to: majord...@ieee.org with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Ron Pickard: emc-p...@hypercom.com Dave Heald: davehe...@attbi.com For policy questions, send mail to: Richard Nute: ri...@ieee.org Jim Bacher: j.bac...@ieee.org All emc-pstc postings are archived and searchable on the web at: http://ieeepstc.mindcruiser.com/ Click on "browse" and then "emc-pstc mailing list"
