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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