IVD/Medical Device Registration (with MHRA DORS account in the UK)

F

fondantcookie

#1
Hi all...

Noobie question again... (another...)

Do all classifications of IVD/Medical device need registering on the MHRA DORS account in the UK?

Or does this just apply to self-declared/general IVD; as the MHRA are made aware of higher classification devices through the notified body involvement?

Thanks in advance! I cannot tell you how helpful you folk are :) Massive thank you
 
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dgrainger

Trusted Information Resource
#2
From MHRA IVD guidance: https://www.gov.uk/government/publi...ostic-medical-devices-guidance-on-legislation

4.2 Registration
Pursuant to Regulation 44, a manufacturer with a registered place of business in the UK who places a relevant device on the market (remember that for these purposes, market means the EU market) or who makes available a device for performance evaluation under his own name must register with the MHRA.
In addition, a person with a registered places of business in the UK who (a) places a relevant device on the UK market, or (b) who makes a device available for performance evaluation, on behalf of a manufacturer who does not have a registered place of business in the Community or in a state which is party to an Association Agreement, must register with the MHRA (see also ‘Authorised Representatives’ below).
Registration will not be required if the IVD was first placed on the market in another Member State (or if applicable in a state which is a party to an Association Agreement) and the manufacturer or his authorised representative has already registered with the Competent Authorities of that state (although note the transitional arrangements which apply pending the setting up of the European database, as to which see later).
Further guidance for registration in the UK is given on our website.
 
F

fondantcookie

#3
From MHRA IVD guidance:

4.2 Registration
Pursuant to Regulation 44, a manufacturer with a registered place of business in the UK who places a relevant device on the market (remember that for these purposes, market means the EU market) or who makes available a device for performance evaluation under his own name must register with the MHRA.
In addition, a person with a registered places of business in the UK who (a) places a relevant device on the UK market, or (b) who makes a device available for performance evaluation, on behalf of a manufacturer who does not have a registered place of business in the Community or in a state which is party to an Association Agreement, must register with the MHRA (see also ‘Authorised Representatives’ below).
Registration will not be required if the IVD was first placed on the market in another Member State (or if applicable in a state which is a party to an Association Agreement) and the manufacturer or his authorised representative has already registered with the Competent Authorities of that state (although note the transitional arrangements which apply pending the setting up of the European database, as to which see later).
Further guidance for registration in the UK is given on our website.
Thanks Dgrainger.

I have heard a number of times though that we only need to register a device/IVD direct with the MHRA if it's Class I/General IVD (ie no involvement of the notified body).

I was thinking this must be because there is some kind of communication between the notified body and the MHRA for the higher classification devices (where a NB is involved)? Or is this not the case...?

Thanks for your help :cool: Slowly but surely getting an understanding :eek:
 
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