Hi, Yes it is required for some of the directives. For the MDD, the requirement is in Article 14, paragraph 2. For the IVDD it is in Article 10, paragraph 3.
If you should have any questions or comments, please feel free to contact me. Sincerely, Ned Devine Entela, Inc. 3033 Madison Ave. SE Grand Rapids, MI 49548 Phone: 616 248 9671 Fax: 616 574 9752 e-mail: [email protected] www.entela.com Entela, Inc. A Certified Woman Owned Business From: Joe P Martin [mailto:[email protected]] Sent: Tuesday, March 25, 2003 8:31 PM To: [email protected] Subject: Is Authorised Representative in EU Required? Greetings, In order to meet the requirements of European Union Directives, if the manufacturer is not established in the Community, is it required to have an Authorised Representative established in the Community? Is the requirement, or non-requirement, the same for all Directives? I am mostly concerned with In-Vitro Diagnostics, EMC, Low Voltage, Machinery and Medical Directives. If you have available, please provide specific Article(s) where this is specified in the Directives or the Directive Guidelines. 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 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
