EU Country Specific Medical Device Registration Requirements

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P

Peter Fr

#22
Hi guys, sorry to dig up an old thread, but does anyone know where I can find a clear and concise document regarding the class II medical device requirements in Germany. I have looked for documents but I seem to only get so far before getting stopped by the language barrier.
Can anyone give me any information on or who I should speak to for basically what would need to be done in order to be able to sell the product in Germany.

Regards,

Jon Taylor
You have to prove, within the technical file, that your product meets the Essential requirements of the Medical Device Directive 93/42/EEC, amended by 2007/47/EC (which is applicable since March 2010). When you checked (and can prove) that your product meets the Annex I requirements, you have to set up a declaration of Conformity, and register the product (by your European representative - if appliacble) at one of the Competent authorities. Once this is done, you can sell the product all over Europe (keeping in mind the applicable language of User manual and label). If you need more information, please let me know.
Regards, Peter
 

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R

reidysseus

#23
So for clarification...

Not all countries require registration into their specific databases? The countries that do require this are France, Spain, Portugal and Italy? So if we have a Class IIb CE marked, ISO 13485 audited device we can begin selling in UK, Ireland, Germany, Netherlands, Norway, Sweden, Finland, Austria, Greece, etc. as long as we meet the language and labeling requirements? Or do we have to notify each government that we are putting our device on the market?

Thank you.
 
E

esalsan

#24
Dear covers,

I would recommend everybody to check the national laws of each individual country (that you intend to sell to) in the EU. It is also dependent, of course, upon the device classification.

I have recently found out that, for example, manufacturers need to register in Poland as per Act of 20 April 2004 on medical devices (Chapter 7); and class I medical devices manufacturers need to be registered in the Netherlands (Farmatec), if you intend to sell there.

I wish we could share a table with all countries, devices and specific requirements like registration and language of labeling (including exclusions for those intended for professional use only).

I know the post is not very recent but if anyone has any ideas on how to coordinate such efforts I would be very willing to participate.
 
A

alex1539

#25
Hello,
You have to register your company and your medical device to the AFSSAPS authority. For medical devices, you do it with a form called "Communication de mise en service des dispositifs médicaux de classes IIa - IIb - III et DMIA", in english: Communication of IIa, IIb, III class medical devices and AIMDD.
You can find it on the afssaps web site www afssaps dot fr (sorry, I'm new on this forum and can't post links yet). Type "afssaps information in english" in your favorite search engine and you'll reach the right page.
You have to declare vigilence events to afssaps as well.

Edit:
And ... you have to pay an annual tax!

Regards.

Mitch
For distribution of medical devices in France, a registration process is needed, which could be done by Authorized Representative in case that the manufacturer's facility is located outside of Europe. My question is that, is there a registration fee required for registration of products with french competent authority? How much is the fee? Does it pay mannually.

Alex
 
C

CBAL08

#26
Does Class I Device need to be registered in markets like Spain, France and Italy if they are manufacturerd outseide Europe? If yes then could someone share a link of who and how?
 

xcanals_tecno-med.es

Involved In Discussions
#27
Dear all

For Spain

class IIa, IIb and III (fee 100 Eur)

The registration procedure is made in the PMPS database:

https://sede.aemps.gob.es/en/PSCH/PS/pmps.htm


Class I devices: you only need to register them in Spain if you are a Manufacturer or an European Representative located in Spain

The registration is made in the RPS database with no fee

https://sede.aemps.gob.es/en/PSCH/PS/rrps.htm


no sales tax (i.e. % of sales in Spain) are applicable

Additionally note that the next year the applicable VAT tax will be 21% for most of the medical devices, until now is the 10%

Regards

Xavier Canals
 

c.mitch

Quite Involved in Discussions
#28
Thanks Xavier

For France
(Sorry all links are in French but google translate does miracles. And a few forms are also translated in english)

class IIa, IIb and III

You have to register your product to the ANSM (French competent authority) when they are imported the first time in France
http://ansm.sante.fr/Activites/Mise...III-et-DMIA-Communication-et-liste/(offset)/3



Class I devices: you only need to register them in France if you are a Manufacturer or an European Representative located in France

Likewise, the registration is made to the ANSM
http://ansm.sante.fr/Activites/Mise...-sur-mesure-assemblage-Declaration/(offset)/2

sales tax is % of sales in France
See: http://ansm.sante.fr/Services/Declaration-de-ventes-annuelles

There are also laws about medical devices advertising
http://ansm.sante.fr/Activites/Publ...cite-pour-les-dispositifs-medicaux/(offset)/0
 
#29
Dear all,

Are there additional specific requirements (excepted official language) for European countries ? (Medical device class IIa)
For example, in France:
- "Device communication" to ANSM (French competent authority) prior to sale
- The year of CE marking must be put on the labeling (near the CE logo)
- Specific requirements about advertising

Also, would someone complete this list of countries where local registration is requested?
- France
- Spain
- Italy
- Greece
- Portugal
- Poland?
- UK?

Thanks !
 

Mark Meer

Trusted Information Resource
#30
Dear all,

Are there additional specific requirements (excepted official language) for European countries ? (Medical device class IIa)
For example, in France:
- "Device communication" to ANSM (French competent authority) prior to sale
- The year of CE marking must be put on the labeling (near the CE logo)
- Specific requirements about advertising

Also, would someone complete this list of countries where local registration is requested?
- France
- Spain
- Italy
- Greece
- Portugal
- Poland?
- UK?

Thanks !
*BUMP*
In this thread so far, several countries have been mentioned that appear to have additional pre-market requirements BEYOND EU Directive requirements and regional translation requirements.

For example, Italy requires local registration, and this last post describes France as having additional requirements regarding notification to French CA, additional CE mark information required, and some additional regulations on advertising. Can anyone cite where these are stated (preferably in an English version of regulations)? Are there other regulations for other countries I need to be aware of?

...and here I thought it was sufficient to follow EU Directive, and that was all that was required...but apparently not in some countries.

It would be really useful to have a resource that summarizes these additional, country-specific requirements.
Can anyone suggest such a resource?
Or, alternatively, if the additional country-specific regulations are few enough to simply enumerate here, that would be most helpful!
 
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