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 Commiss
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 I
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