Countdown to MD and IVD Registration deadlines… only 24 days to go!
Countdown to UK Medical Device and IVD Registration deadlines … only 24 days to go!
Medical device & IVD manufacturers selling their products in the UK must register all devices with UK MHRA by 31st December 2021, to be able to continue to sell them legally in the UK.
This applies to both UK manufacturers and those outside Great Britain
For Medical Device and IVD manufacturers in the UK, whether you have a current valid UKCA mark or CE mark, you must still register your products before the 31st December final deadline, to meet the new post-Brexit requirements;
‘ Failure to register from these dates will mean that you will no longer
be able to lawfully place your device on the Great Britain market ‘
Recognition of CE marked products for manufacturers based outside the UK, will also only continue within Great Britain, if your device is registered with UK MHRA.
And that’s not all …
UK Responsible Person (UK RP)
Manufacturers who are based outside of the UK must appoint a UKRP based in the UK to act on their behalf. UKRPs have a key role in acting as a point of contact for the MHRA, and for registering the devices with them.
Further obligations include;
- ensuring that Technical Documentation and the Declaration of Conformity have been properly drawn up
- informing the manufacturer of any complaints or reports of suspected incidents that occur within the UK.
Before 1st Jan 2022, under the new rules, overseas manufacturers must;
- select a suitable UKRP
- put in place a written letter of designation with their chosen UKRP
- provide the UKRP with all appropriate product documentation
- advise their UKRP of all UK importers of their products
- ensure that the UKRP registers their product correctly and before its classification deadline
So, there is a lot to do if you haven’t started the registration process yet!
Whether you need to appoint a UKRP or just support with the registration process, IMed can help. We have lots of experience registering all types of devices and IVD and we are also a Registered UK Responsible Person.
If you haven’t already registered your device or IVD, simply contact me now at email@example.com or by telephone on 01295 724286 and we’ll set you on the right track.
Business Development Director