If you intend to place your device on the UK market, you must now make note of the following:
It is a requirement of the UK MDR 2002 that you inform the MHRA before you place your device on the market in Great Britain.
You must register if you or your company sells, leases, lends or gifts:
- Class I, IIa, IIb or III devices you have manufactured
- Class I, IIa, IIb or III devices you have refurbished or re-labelled with your own name
- any system or procedure pack containing at least one medical device
- custom-made devices
- IVDs you have manufactured
- IVDs undergoing performance evaluation
There will be a grace period to allow time for compliance with the new registration process.
The registration requirements will apply from 1 January 2021, although current registration requirements will continue to apply. You can register devices ahead of these dates, but there will be no legal obligation to do so.