Hi Mark, No. The MDD, Article 14 address this. You only have to register with the CO of the country where you have your authorized representative. But, I have heard that some countries have passed national laws requiring you to register all devices.
Ned Devine Entela, Inc. Program Manager III Phone 616 248 9671 Fax 616 574 9752 e-mail [email protected] 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 I 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. -----Original Message----- From: Mark Schmidt [mailto:[email protected]] Sent: Monday, January 24, 2000 12:00 PM To: [email protected] Subject: Competent Authorities Dear Members, In the EEC if I register a Class I Medical Device with a Competent Authority in one Membered State, must I register with other Competent Authorities as we eventually market product their State. All input is appreciated. Regards, Mark Schmidt X-Rite Incorporated Grandville, MI U.S.A. [email protected] phone - 616 257 2469 --------- 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). --------- 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).
