EBME Forums Forums Management Medical Equipment Management Medical Device Regulatory News

I have learned that UKCA marking will only apply to products placed on the market in Great Britain. In other words, CE marking and all the rest of the status quo ante will apply in Northern Ireland.

There is even a UKNI mark ... and in some cases equipment will be required to carry both that and the CE mark.

Hopefully, situations like this will be sorted out once (or if ever) our Government gets a grip post-Covid (please let it be soon).

I look after the PAQ approval process for our trust and the MHRA & UKCA regulations are just another couple of boxes to tick. Maybe they should update the PAQ 2018 form so that the suppliers have to disclose the registration and UKCA information?. Most of the PAQ's I get don't even have the GMDN or GS1-GTIN codes that would make it simpler to search as Stargolf said.


@Goff... 1945 C11 that had been stored for 30 years before I took it into care.

Yes; the PAQ form could do with an update.

And yes; you would think that suppliers would be able to produce any or all "universal" codes for the stuff they are hoping to supply (sell).

Personally, I would reject any that don't or can't. Why? Because it's an indication that they may not be (or more likely, aren't) serious players ... therefore bringing any other declarations they make into doubt.

Yes; C11 had plunger rear suspension (as did 200 cc Ariel Colt) ... whilst C12 had swinging arm. PM sent.

So we have a situation that a company are trailing a stack system and have a current MIA agreement No. However the equipment/company are not listed on the MHRA spreadsheet. So should the equipment be in the hospital?

Hi Owen,
It will depend on when the equipment was put on site and how long its been in the country ie

If it was brought into stock in the uk by the company before 1/1/22 then it ok. If however if it was brought in after that date then according to the rules laid down by MHRA they have brought it in illegally.

Does the device/stack have a GMDN code classing it as a medical device.

It can take upto three(3) to get registered

Hope this helps

Hi Mike, I haven't got any figures but job opportunities are starting to show an improvement especially at MHRA now they are the sovereign regulator. While people may have views on Brexit, my positive spin for students is that some may not wish to be coal face engineers and there are certainly more regulatory biased posts due to the new UKCA requirements.

HI Geoff - FYI, in NI, the UKCA mark and the CE mark will be marketable.