EU Medical Device Requirements and Government Authorities

01mercy

Involved In Discussions
#1
Hi all,

Can anyone tell me what the government authorities in EU are regarding medical devices and when you are suppose to be in contact/audited/register with/by/at them?

Is there any guideline which states when you should, as a distribution centre or as a manufacturer, justify or register your practices?

Thanks.
 
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pkost

Trusted Information Resource
#3
Re: EU medical device and government authorities

The EU directives as they currently stand only place obligations on a manufacturer, it does not obligate distributors.

That being said, although it is the EU, with a central directive, each country "interprets" the directive in their own unique way. As such some countries have different registration requirements (even for distributors)

It would be best to speak to the local competent authorities in each state to establish their particular requirements

You can find a list of the competent authorities here:
http://ec.europa.eu/health/medical-devices/files/list-of-contact-points-within-the-national_en.pdf
 
M

MIREGMGR

#4
You haven't indicated whether you have a business location in the EU, or are external and ship your devices into EU. If the latter, you should have an Authorized Representative within EU, and that Authorized Representative should be knowledgeable in regard to all of the questions you pose here.
 
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