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Joe Hage
🔥 Find me at MedicalDevicesGroup.net 🔥
August 2016
EU special registrations before marketing a device
< 1 min reading time

Does anybody have a list of European countries Competent Authorities / Ministry of Health that require further communication/declaration/registration once the CE-mark obtained? Thank you for you help!

source: https://www.linkedin.com/groups/2070960/2070960-6174598058387521539

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Posted by Joe Hage
Asked on August 25, 2016 8:00 am
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Hi,
that's gonna be a long journey... You will find all the national competent authorities by following this link: http://ec.europa.eu/growth/sectors/medical-devices/contacts_en
Registration in EU member states is different from Country to Country. In Germany it will be via dimdi. Nearly each Country in EU requests notification for vigilance purposes. Situation will improve under the new MDR when EUDAMED will be established. Good luck!
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José E. Cabrera Certainly Italy and Spain require an upload of labels and IFU prior to selling in those countries - others have not been consistent. It depends on what the Risk Class is also...
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http://www.raps.org/Regulatory-Focus/News/Databases/2015/02/20/21397/The-Essential-List-of-European-Pharmaceutical-and-Device-Regulatory-Authorities/
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Maurizio Colombo Hi,
To my knowledge the situation is as follows:
Italy: requires additional local registration for all MD (excluding class I non sterile and without measuring function)
France: requires additional Communication for MD class IIa, IIb, III
Belgium: requires only the distributor to be accredited
Spain & Portugal: require additional Communication for MD class IIa, IIb, III
Hungary: requires additional local registration for all devices to be made by a local representative with place of business in Hungary
you will find the details on the single websites of the local competent authorities.
Bye,
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G M Butcher If you have an external Authorized Representative they (even an internal one) should be able to help. Also your Notified Body. Don't perform work that you pay others to perform.
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Alex Kennedy The UDI time schedule has been added to a page in Validation Online group.
Alex Kennedy
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