Requirements for CE Marked Class I Medical Devices for EU and Canada

P

PMIN92618

#1
I am new to International requirements for Medical Devices. We have self CE marked our class 1 products. What are the requirements for EU and Canada? Labeling requirements? Are there specific countries in the EU that have additional requirements?
 
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Ronen E

Problem Solver
Moderator
#2
Re: What are the requirements CE Marked Medical Devices for EU and Canada?

Hi,

If you have CE marked your devices then you should have already met the applicable EU requirements, including those that relate to medical devices labelling; if you haven't done so then your CE marking is in breach of the EU regulation. Generally speaking, the only additional requirements (on top of the Medical Devices Directive - the MDD) that specific EU member states apply relate to registration. Some require registration above and beyond the minimum that the MDD requires. National language translations may be required in some EU member states, however those are still within the scope of the MDD, so I wouldn't consider them "additional".

Canada has its own requirements, see here.
 
B

Bigdubz61

#3
Re: What are the requirements CE Marked Medical Devices for EU and Canada?

The way I understand this situation is that if you want to sell a class 1 device in Canada, you don't need a Device License. As long as you have the Technical File and you are selling through a Canada -based Agent, you fulfill the requirements. Although I do stand to be corrected.
 
P

PMIN92618

#4
Re: Requirements for CE Marked Medical Devices for EU and Canada?

Thank you. We are using a Canadian distributor, so I believe we are ok on that end.

Is there a good site anyone can recommend that shows what the requirements are for different countries? I use the Emergo site quite frequently, are there others?
 

Ronen E

Problem Solver
Moderator
#5
Re: Requirements for CE Marked Medical Devices for EU and Canada?

Thank you. We are using a Canadian distributor, so I believe we are ok on that end.

Is there a good site anyone can recommend that shows what the requirements are for different countries? I use the Emergo site quite frequently, are there others?
I don't think you will find anything more condensed than Emergo.

Other than that just Google "[country] medical devices regulations".
 

mihzago

Trusted Information Resource
#6
Re: What are the requirements CE Marked Medical Devices for EU and Canada?

The way I understand this situation is that if you want to sell a class 1 device in Canada, you don't need a Device License. As long as you have the Technical File and you are selling through a Canada -based Agent, you fulfill the requirements. Although I do stand to be corrected.
You still need an Medical Device Establishment Registration, unless you have a distributor and that distributor has an Establishment Registration. If your company distributes directly, then your company needs to register.
 

shimonv

Trusted Information Resource
#7
Re: Requirements for CE Marked Medical Devices for EU and Canada?

Thank you. We are using a Canadian distributor, so I believe we are ok on that end.

Is there a good site anyone can recommend that shows what the requirements are for different countries? I use the Emergo site quite frequently, are there others?
The developing countries are not well organized with English resources like FDA's "Device Advice". This plus frequent updates makes it a special challenge. Networking and professional forums like Elsmar is the key for successful global registration.

Shimon
 
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