Class III Medical Device in Netherlands - Member State Country Notifications?

[RAspecialist]

Hi

I wonder if anyone can help. I have a Class III Medical Device for which I have just obtained a CE mark for. For it to be used in each of the member state countries do I need to complete any notifications/registrations?

I urgently in particular need to know about the Netherlands.

Can anyone help?

Many Thanks

 

[Charlotte Percy]

Hello,

If you want to know for certain your best bet is to contact the competent authority in the country you seek to market the device to see if there are any local registration requirements. A list of the competent authorities can be found at:

http://www.ecrep.com/Library/Guidance/Europa%20-%20Enterprise%20-%20Medical%20Devices%20-%20List%20of%20Competent%20Authorities.htm
Local requirements can be a moving target, better to go to the source IMHO.

 

[bio_subbu]

As Charlotte Percy mentioned, you may want to contact the competent authority of the each member state where the product is marketed. Normally, the product registration can be done through manufacturers with registered office in member states or authorized representative or distributors. A list of contact points (PDF version) for medical devices national competent authorities can be found on http://ec.europa.eu/enterprise/sect...-of-contact-points-within-the-national_en.pdf

Regards
S. Subramaniam

 

[RAspecialist]

Thank you both for your help

 

[Roland Cooke]

As another long-serving RA Specialist: my so-called expertise basically boils down to knowing whom to ask.