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Thought you all may wish to see this

https://www.gov.uk/guidance/regulating-medical-devices-from-1-january-2021

Thanks for the link.

From what I understand, for medical devices which have a CE mark, nothing much will change until 2023 (assuming that the manufacturers of those devices can obtain a CE mark - currently through the MDD, soon under the MDR).

Custom and in-house manufactured devices will need to meet the requirements of the UK 2002 Medical Device Regulations. I expect that these will be aligned with the EU MDR etc in due course once the new UK Medicines and Medial Devices Bill has been passed. There may however, at some point, be some divergence between the EU and UK medical device regulations. If/when this happens, manufacturers would have to comply with two different regimes to get access to both markets.

As stated in the guidance, there will be an additional requirement for medical devices to be registered with the MHRA following a certain grace period.

That's right plus I hope it will bring job opportunities for the profession because somebody needs to evaluate or certify devices in the UK for the UK system. I note it is different for NI as they can still use CE marked devices - wise to read up on these aspects if you are in NI...... Interesting indication for GB/UK general regulations in the future as well

I would not hold out for many job opportunities, as approved bodies may be international companies with a UK registered office. All the assessment work will be undertaken at existing international locations and only the final paperwork will be passed via the UK office.

If every medical device had to be tested in an UK facility you would expect a reduced choice of products available in the UK market and they would be at an increased cost!

Well as of 1st January 2022 all classes of medical devices will need to be registered with the MHRA. We have already found companies that have not registered devices and therefore cant sell them in the UK. The MHRA have got a register which lists the companies, however It is not easy to search and find particular devices. The next hurdle will be the UKCA and UK registered person requirements that come into effect on the 30th June 2023.

https://aic.mhra.gov.uk/era/pdr.nsf/name?openpage&start=1&count=200.

Owen, Think you will find that the UKRP (uk responsible person) comes into affet from 1st Jan 2022 its the UKCA that is Ist June 2023
and its a pain in to do it and will cost you £100.00

if you look on this link https://aic.mhra.gov.uk/era/pdr.nsf/Search?openform you will find devices that are registered with MHRA to comply with this UKRP and who the UKRP is

To do what? Presumably you're referring to a company getting registered ... or maybe a single device type. How does that work, I wonder; does each new device coming to market need to get registered? I don't see specific model types etc. listed in the linked database ... just generic names.

Yes, those links are interesting. It looks like MHRA has put in a fair amount of work there. But as Owen has implied, there is plenty of room for improvement. For instance, I can't help but wonder why one (or more ... or even all) of the "universal" (international, whatever) equipment codes have not been included where appropriate.

Meanwhile, manufacturers (suppliers?) now need to be registered with the MHRA, as well as any new medical device to be sold in the UK. Can we presume that older equipment (those already in service) are deemed to have been permitted under the previous regime, and can therefore continue to be used until the end of its normally expected lifespan?

At hospital level, who is responsible for ensuring that equipment is registered under the new scheme? I'm guessing that another box to be ticked during the Acceptance procedure shall suffice.

Lastly, how (if at all) is "non-new" equipment affected by all this? Used equipment bought and sold ... at auction. etc.

@Owen ... is that a BSA C11 or C12 ... or maybe an Ariel Colt?

Hi Geoff

As I have been through the process I think I can answer all your question, will start with the asy one to answer and thats your last point.

1.Equipment already in the uk is not affected and its not required to be registered.

2.No starting at the begining. The manufacturer has if they do not have a base in the uk then they have to formally appoint a UKRP with a formal contract which can not be longer than 5 years. Then the UKRP has to register the manufacturer on the MHRA system and upload the contract to the system. Then you need to add the device that is being imported by model number and by DORS number( ie the GNDM code number). And this applies to each different device eg (a)Infusion pump(b) suction device and it will cost £100.00 per device. You then have to add list of importers so if a distributor is importing they needed to be added. Word of warning if you get any information wrong even accidently they will reject the application and you have to resubmit and pay another £100.00

3.re Manufacture's (suppliers) older equipment is not affected. If its a new device and the manufacturer's UKRP has to register the device before it can be brought into the country the UKRP can be the manufacturer if they have a registered office in the UK. And from 1/1/22MHRA have made it a illegal to bring in a device that is not registered with them even though the device is all ready on the market in the uk.

4 Hospitals is a good question if the manufacturer gets and order from a Hospital they should inform the UKRP of this and notify the hospital who the UKRP is.

5 its a requirement to put a label on the device giving the contact details of the UKRP eg look at the side of the box on any lateral flow test.

Hope this clarifies

That's good information. Thanks for the clarifications.

Another sticker, then. And they are using GMDN.

The last sentence of para.3 seems a bit mean, though. One wonders what would happen if kit already in use fails to gain approval for future sales.

I wonder where all those £ 100's end up ... into the Treasury pot to be wasted (er, spent) elsewhere, I suppose.