RE: Competent Authorities
Mark, No, you only need to register with one member state. There was an attempt about 2 years ago by some countries to insist that registration had to be done on a national basis, but I am reliably informed by the Medical Devices Agency in the UK that it was knocked on the head by the EC Commission in Brussels. I see from your address that you are located in the USA. If this is your manufacturing location then you need to appoint someone to register the products on your behalf. This is either someone selling the product or your legally appointed authorised representative. The person must be located in the EEA (EU plus Norway, Iceland or Liechtenstein). I suggest that whoever you use, including a member of your own company who is located in the EU, be formally appointed. Medical products are high risk from a compliance point of view (think FDA here!) and so you should get everything in place and correctly done. Do not try to cut corners. My company registers products and acts as an authorised representative and we get audited for completeness of documentation. Do not forget that you need a vigilance scheme in place - the competent authorities always check this one. Regards Martin Green Tel:(44) 1793 784545 Fax: (44) 1793 784551 -Original Message- From: Mark Schmidt [SMTP:mschm...@xrite.com] Sent: 24 January 2000 19:43 To: emc-p...@majordomo.ieee.org 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. mschm...@xrite.com phone - 616 257 2469 - This message is coming from the emc-pstc discussion list. To cancel your subscription, send mail to majord...@ieee.org with the single line: unsubscribe emc-pstc (without the quotes). For help, send mail to ed.pr...@cubic.com, jim_bac...@monarch.com, ri...@sdd.hp.com, or roger.volgst...@compaq.com (the list administrators). - This message is coming from the emc-pstc discussion list. To cancel your subscription, send mail to majord...@ieee.org with the single line: unsubscribe emc-pstc (without the quotes). For help, send mail to ed.pr...@cubic.com, jim_bac...@monarch.com, ri...@sdd.hp.com, or roger.volgst...@compaq.com (the list administrators).
RE: Competent Authorities
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 ndev...@entela.com 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:mschm...@xrite.com] Sent: Monday, January 24, 2000 12:00 PM To: emc-p...@majordomo.ieee.org 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. mschm...@xrite.com phone - 616 257 2469 - This message is coming from the emc-pstc discussion list. To cancel your subscription, send mail to majord...@ieee.org with the single line: unsubscribe emc-pstc (without the quotes). For help, send mail to ed.pr...@cubic.com, jim_bac...@monarch.com, ri...@sdd.hp.com, or roger.volgst...@compaq.com (the list administrators). - This message is coming from the emc-pstc discussion list. To cancel your subscription, send mail to majord...@ieee.org with the single line: unsubscribe emc-pstc (without the quotes). For help, send mail to ed.pr...@cubic.com, jim_bac...@monarch.com, ri...@sdd.hp.com, or roger.volgst...@compaq.com (the list administrators).
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. mschm...@xrite.com phone - 616 257 2469 - This message is coming from the emc-pstc discussion list. To cancel your subscription, send mail to majord...@ieee.org with the single line: unsubscribe emc-pstc (without the quotes). For help, send mail to ed.pr...@cubic.com, jim_bac...@monarch.com, ri...@sdd.hp.com, or roger.volgst...@compaq.com (the list administrators).
