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Overview of European Regulations of Medical Device

M

Mike_Benz

#1
Hell all!

My company is gearing up to search for Medical Device distributors in Central/ Eastern Europe and the Stans.

I'm hoping to find a regulatory overview of the registration documents that are needed with each European country. I know that some countries accept CE/ ISO, others CFG, etc.

Does anyone have a go-to resource that outlines:
a - which countries require which documents
b - which languages can be used on the label (professional). I have narrowed the bulk of the region to English, German, an Russian. We will likely add Czech as well.

Thanks so much!

:thanks:

Best,

Mike
 
Elsmar Forum Sponsor

Ronen E

Problem Solver
Staff member
Moderator
#3
Hi,

That "go-to resource" is Elsmar Cove.

Use the search box on the top left hand, and search for the countries of interest, one by one. For labelling language threads search for "translation". Read everything you can find and you'll cover at least 70-80% of what you need to know. The rest you can find using more focused web searches or through asking more focused questions here.

For countries that are member states of the EC most of the requirements are covered by CE marking of medical devices. Nevertheless, some member states have unique requirements on top of that.

Cheers,
Ronen.
 
M

Mike_Benz

#4
Thank you for your reply Ronen. We certainly will search the Elsmar Cove archives.

However, if a table showing a snapshot overview of language/ regulatory document breakdown of each European Country that would certainly expedite the process.
 

sagai

Quite Involved in Discussions
#5
Mike,
highly likely you will need a notified body anyway, I tend to suggest to discuss such a broad topic with them.
You should know the product, its classification, corresponding legislation, target markets, connection between product lunches on target market, etc. it is fairly complex to have one overall set of report to look into.
Regards
Szabolcs

ps.:
I would start here from documentation prospective:
http://ec.europa.eu/enterprise/poli...onised-standards/medical-devices/index_en.htm
 

Ronen E

Problem Solver
Staff member
Moderator
#6
Thank you for your reply Ronen. We certainly will search the Elsmar Cove archives.

However, if a table showing a snapshot overview of language/ regulatory document breakdown of each European Country that would certainly expedite the process.
Hi,

You can also look in the Cove's Post Attachment Files: http://elsmar.com/Forums/fileslist.php. Various matrices / overviews have been posted over the years.

if you can't find exactly what you're looking for, have a look at my signature. ;)

Kind regards,
Ronen.
 
M

Mike_Benz

#8
Thank you so much to all who posted!

We have a lot of research to do!

Search Elsmar Cove so far has been the most practical and comprehensive approach.

Best,

Mike
 
C

Caravan

#9
Hello Mike,

generally you only need one registration for all 28 EU member states. There are very few add-ons, which mostly are having an impact on the local distributor. More important, before going anywhere, regulation requires a "European Representative" (if you located outside the EU) who must register with the authorities at his place of business. He must have direct access to the Technical File. What is needed in regard to documentation depends on the classification of your product. Language requirements are also depending on the intended user - professional or non-professional.

Best
J?rgen
 
M

Mike_Benz

#10
Hello Caravan,

Thank you for that clarification. I assume the same is true for France/ Germany/ UK/ Finland/ Netherlands/ Sweden/ and Italy?

If so, that is great news.

BTW, our products are strictly for professional-use.

As for the non-EU member states, I would imagine each is drastically different and need to be independently evaluated. Correct?

thanks again!

best,

Michael
 
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