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Medical Device - CE marking - Local market notifications

#1
Hi,

I wonder if someone would be able to help me out.

I am looking to work out the costings of registrations for a Class I medical device.
I understand once all documentation is completed local market registration is required, in the UK with the MHRA and also where our EC rep is located with their competent authority.

My understanding however is some markets still require local notification before placing on the market. How can i find out which markets within the EEC need this and what the costs associated are?
Any advice would be appreciated

Thanks
 
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#2
Hi,

I wonder if someone would be able to help me out.

I am looking to work out the costings of registrations for a Class I medical device.
I understand once all documentation is completed local market registration is required, in the UK with the MHRA and also where our EC rep is located with their competent authority.

My understanding however is some markets still require local notification before placing on the market. How can i find out which markets within the EEC need this and what the costs associated are?
Any advice would be appreciated

Thanks
£100 applies for each registration application that can include up to 100 device types
MHRA updates are £100 including updating your UK Authorised Rep to a UK Responsible Person

If you're looking for a UK Responsible Person and you're a small company, you could work on a retainer and hourly rate for any subsequent work

From memory I can't remember which countries required the local notification, but I do remember they were a lot less work than a CE marking application. Ukraine may have been one. Your EC Rep should already know.
 

Salisburysteve

Starting to get Involved
#3
I have tried to apply for Class I registration with the NL IDJ as a UK based company and that hit a wall when I couldn't obtain the credentials to log in to the registration site (eHarkenning). The obstacle was that I didn't have a KvK (Chamber of Commerce) entry. I am now asking my EU AR for our Class IIa devices if they can assist.

Regards,
 
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