Declaration required for MD First Marketing in UK, DE, CH, BE and NL

J

JohnB2

#1
Good morning,

I would be grateful if someone could provide with the requirements for first marketing of a CE marked medical device in the following EU countries:
- United Kingdom
- Germany
- Switzerland
- Belgium
- Netherland.

I know that such a "declaration" is required in France, Italy or Spain before/at the time the device is put onto the market for first time (submission of a form with IFU and labels), but have no information on the above listed countries.

Thnak you in advance!
JohnB
 
Elsmar Forum Sponsor

pkost

Trusted Information Resource
#2
you do not specify the class of device, which would be helpful.

Class I - you are required to inform the Competent authority of the country you are based in (or your EC rep)

Class IIa,b,III requires no action as the NB will review your documentation


In addition, when you actually come to making the product avaliable on the market:

Italy and Spain only require notification for IIa or higher.
France - not sure (I should know)
UK and Germany - no additional requirements
Belgium, Netherlands - not sure, I haven't heard of any notification procedure in these countries
Switzerland - not sure, I wouldn't have had any reason to hear of any notification procedure here
 

sagai

Quite Involved in Discussions
#3
I think for EU all you have to do is to comply with the CE marking requirement, assess your conformity with the notified body and apart from the general requirement for CE marking and some rigmarole with the notified body as regard, nothing else to do due to it is EU. (probably Switzerland is different, but I am not sure).
Cheers!
 

pkost

Trusted Information Resource
#4
Hi Sagai,

directives allow member states to "interpret" before transposing into national law; a number of the countries have decided to "interpret" some of the directive clauses such that the manufacturer, or distributor, inform the CA when they make a product avaliable on their market.

Welcome to the not quite harmonised EU!
 
J

JohnB2

#6
Hi,

Thank you for your answer, appreciated!

For France I know that first marketing declaration is mandatory for all EU risk class devices (in addition to the CE mark).

For Switzerland, only Class I device are to be declared, according to Swissmedic - Guidance on MD regulation.

For UK and Germany, it seems thus that no declaration is required.

For Belgium and Netherland, I am not sure what to do...

JohnB2
 
D

depa1978

#8
Hi!!

Italy requires a notification for Italian or foreign complanies for all classes.

For France we are not notifying Class I devices. The information for the process are well described on the website.

For Belgium, a notification is required for some devices listed in the Royal Decree

I don't think it is necessary to register devices in UK and NL, while I am exploring DE and going mad with SPAIN!!!:frust:
 
B

Burgmeister

#9
As has already been mentioned, Spain, Italy & France require regsitration. Trying to find info on Belgium and NL at the moment. Switzerland has signed up to using the CE mark and, as I understand it, require regsitration for Class III devices (and presumably class I as per the rest of the EU).

It would be handy to have a definitive list of which EU (and EEA) countruies require registartion and which ones don't!

Ooh, just found this site which has some useful info: http://www.arazygroup.com/medical_device_registration_in_spain_
Just click on the relavant countries listed down the LHS of the page.
 
Last edited by a moderator:

sagai

Quite Involved in Discussions
#10
Gents,
the whole concept of CE marking is about a one time kind of unified registration for EU.
I have really never before come across otherwise for our ClassIIa devices, however it does not exclude the possibility for certain type of devices.
Cheers!
 
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