Selling a CE mark Class I Medical Device in Sweden - Any other requirements?

G

Gaya123

#1
Hi

My company got CE mark to its device
I wanted to ask if that is enough for selling in Sweden?
Or there are other requirements that we have to follow?

Regards

Gaya
 
Last edited by a moderator:
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harry

Super Moderator
#2
Re: Selling in Sweden

I guess this is a medical device. More information such as class or type should help others to give you a better answer.
 
G

Gaya123

#3
Re: Selling a CE marked Device in Sweden - Any other requirements?

Yes

It is a Class I medical device

Thanks

Gaya
 
R

Ron Boumans

#4
Re: Selling a CE marked Device in Sweden - Any other requirements?

To facilitate free movement of good in EU products that are in compliance with the legislation can be identified by the CE mark. Presuming that this CE mark is put on the device after the correct procedure has been followed, this device should be allowed free access to any member state. That includes Sweden.

But from the way this question is formulated I get the feeling that you better check if the CE mark is indeed justified.
 

Pads38

Trusted Information Resource
#5
Class I is comprised of the least dangerous devices and is the largest group. If a manufacturer of class I devices has his registered place of business in Sweden, he or his authorised representative, with a registered place of business in Sweden, shall send notification of the company and the device/s to Medical Products Agency which will register the company and the devices against an annual fee.

Medical Products Agency will issue confirmation of registration in the form of a Certificate of Registration which allows the device/s to be placed on the market.
Something which manufacturers in particular have to observe, is that labelling and instructions for use (users manual, display, voice etc) according to paragraph 4 in the Regulations (LVFS 2001:5, LVFS 2003:11 and LVFS 2001:7 respectively) shall be written in Swedish. This is irrespective of the device being used by a patient or by trained staff or if the device is used in a hospital or in an accommodation. Service manuals might be in english.
Comprehensive information from here:

http://www.lakemedelsverket.se/english/product/Medical-devices/
 
G

Gaya123

#7
Hi

My company got CE mark to its device
I wanted to ask if that is enough for selling in Sweden?
Or there are other requirements that we have to follow?

Regards

Gaya

Hi

Regarding my previous question
Can I ship a demo device to Sweden before implementation of all prevoius requirements?

Thanks

Gaya
 
Last edited by a moderator:

Pads38

Trusted Information Resource
#8
That may be covered by Article 4, paragraph 3 of the directive.

These devices shall not bear the CE marking.

3. At trade fairs, exhibitions, demonstrations,
etc. Member States shall not create any
obstacle to the showing of devices which
do not conform to this Directive, provided
that a visible sign clearly indicates that
such devices cannot be marketed or put
into service until they have been made to
comply.
 
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