Hi Anon,
In order to market in Great Britain, devices must either be CE Marked or UKCA Marked. Once a device is CE or UKCA Marked, it must then be further registered with the MHRA. That registration will identify if the device is CE or UKCA marked, and the accompanying verification must be provided. For Class I self-certified devices, it will be the signed MDR-compliant Declaration of Conformity. For custom-made devices, it will be the custom-made statement drafted per MDR Annex III.
Part of maintaining valid CE Marking, for non-EU companies, is the appointment of an EU Authorized Representative (AR). If you are looking to cancel your EU AR service, in order to save on costs, then this impacts your CE Marking.
In this case, you could transition your devices to UKCA Marking, and then you will be compliant. The UK regulation (UK MDR 2002) is currently based on the old European Directives. In the case of your devices, the Medical Devices Directive (MDD) 93/42/EEC.
Therefore, an MDD-compliant technical file aligns with the UKCA technical file requirements. However, there are some gaps that must be addressed for your Class I self-cert device. Examples of gaps include:
- UKCA symbol must be used instead of the CE symbol
- UK Responsible Person (UKRP) is required instead of an EU Authorized Representative (EC Rep), if you are located outside of the UK
- Applicable legislation referenced through the technical file should be the UK MDR 2002, e.g., the Essential Requirements would cite the UK MDR 2002
- UK Declaration of Conformity, citing UK regulations, must be signed by the manufacturer
- Since the UK MDR 2002 is based on the MDD, no requirement for a PRRC appointment or other MDR specific items (yet, anyway – you can expect these to be required under the UK's new proposed regulation)
It should not be tremendous work to convert your documentation from CE to UKCA Marking. But you do need UKCA-compliant documentation prior to applying the UKCA marking symbol to your Class I device labeling. The custom-made device, of course, does not have the CE Marking symbol applied, and also would not have the UKCA symbol applied.
Once the device is UKCA Marked, you would indeed need to re-register the device with the MHRA. When you originally registered, you supplied the EU documentation, and noted that the device had CE Marking and conformed to EU legislation. You will need to re-register the device with your UKCA Marking information. You will then deactivate the other registration for the CE Marked device.
Note that if you UKCA mark under the current regulation UK MDR 2002, when the new regulation goes into effect July 2024, the device is eligible for a three-year transition period before it needs to comply with the new UK regulation. You can certainly transition to the new regulation before that, but the MHRA will give companies with UKCA marking under the current regulation, a timeframe to transition to the new regulation. More about that can be read in the MHRA's Transitional Provisions, specifically section 74.2 The government response, towards the bottom of the page.
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Sydney O'Connell
Director of Global Representation
Dallas TX
United States
www.casusconsulting.com------------------------------
Original Message:
Sent: 08-Dec-2022 12:53
From: Anonymous Member
Subject: EU MDR to MHRA in GB
This message was posted by a user wishing to remain anonymous
Dear peer,
I need please your advise on one point.
Today we are registered with MHRA based on the fact that we are EU MDR approved.
But now we want to be only in UK because we no longer sell any product in EU but in UK specifically in GB.
My question is, do we need to register again our product with MHRA under UK MDR 2002 while it has already been registered or should we wait for the transition period and be register under the new UK regulation maybe in June 2024 .
PS: our product are self certified (class I and custom made) and we want to cancel ou EU-RA contact next month to save cost.
Thank in advance for you input.
Rgds,