Class III Medical Device with CE Mark - UK Registration Process

[Raj Vimal Dev]

May I know what is the procedure for registering a Class 3, CE marked device with MHRA in UK. I was not able to get much help from their website.

Any help is much appreciated. Thanks in advance.

RAJ.

[yana prus]

I would suggest first to check out if you need to register in MHRA

[rob73]

You say the product is CE marked, so is the device already being distributed in the EU by an authorised repersentative? If so there should no problems as you are by default registered within the EU via your representative (is'nt the common market great!).
Have a good read of the guidance notes given by Yana they expalin everything clearly (?!)
Rob

[arnoholm]

In Reply to Parent Post by Raj Vimal Dev

May I know what is the procedure for registering a Class 3, CE marked device with MHRA in UK. I was not able to get much help from their website.

Any help is much appreciated. Thanks in advance.

RAJ.

Unlike in some other EEA member states, a CE-marked class III medical device does not require a registration via the UK-based Authorised representative (EC Rep) with the competent authority MHRA in UK.

[arnoholm]

In Reply to Parent Post by rob73

You say the product is CE marked, so is the device already being distributed in the EU by an authorised repersentative? If so there should no problems as you are by default registered within the EU via your representative (is'nt the common market great!).
Have a good read of the guidance notes given by Yana they expalin everything clearly (?!)
Rob

The Article 14 of Directive MDD 93/42/EEC amended by 2007/47/EC does not require the mandatory registration of a CE-marked class III medical device with the national competent authority via the single authorised representative established within the EEA.

[Raj Vimal Dev]

Thank you all for the informative replies.


For the benefit of others who might have the same question, I will summarize the information below.

=> The CE marking means “Free Circulation in the European Territory” – as such, if your device is CE certified it may freely enter the EU market (UK included of course).

=> You need to take care that the Labeling, Instructions for use (IFUs) and other information which are accessible to the potential users in the UK will be in the language of the relevant member state the device is to be sold in - English of course is the required language in the UK.

=> The mention of the EC REP is obligatory as a means for the European Authorities to contact your Authorized Representative in Europe.

[Citizen Kane]

Found some usefull info here:

http://ec.europa.eu/taxation_customs...s/index_en.htm