Greetings, The In-Vitro Diagnostics Directive requires that any manufacturer who places a device on the market notify the competent authorities of the Member State(s) in which he has his registered place of business. I have a couple of questions in regards to this requirement.
1. Does this mean that we have to register with every regulatory authority in all Member States, or is registration with one Member State sufficient? The product is not manufactured in the EU, yet we do have places of business in several Member States. 2. For General IVD devices, how does a U.S. manufacturer register their product in Europe? 3. Does anyone have a list of the regulatory authorities for all Member States? As always, your responses are greatly appreciated. Regards Joe Martin Applied Biosystems [email protected] 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: [email protected] with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Ron Pickard: [email protected] Dave Heald: [email protected] For policy questions, send mail to: Richard Nute: [email protected] Jim Bacher: [email protected] Archive is being moved, we will announce when it is back on-line. All emc-pstc postings are archived and searchable on the web at: http://www.ieeecommunities.org/emc-pstc
