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).
