It’s official, the registration transition period is over.
The UK MHRA has updated its guidance on “Regulating medical devices in the UK” to remove information related to the 2021 registration deadlines. Instead, it shows the current state requirements for all manufacturers going forward.
The guidance has now been updated to state that “all medical devices, including IVDs, custom-made devices and systems or procedure packs must be registered with the MHRA before being placed on the Great Britain market”.
As well, “failure to register your devices will mean that you are unable to lawfully place your device on the Great Britain market”.
The older version of the guidance stated the registration deadlines for medical devices as:
- May 1, 2021 – Class III, AIMD, Class IIb implantable; IVD Annex II, List A
- September 1, 2021 – Class IIb non-implantable, Class IIa; IVD Annex II, List B, IVD self-test
- January 1, 2022 – Class I, custom-made; general IVDs
The previous version of the guidance also stated that manufacturers should appoint their UK responsible person (UKRP) ‘as soon as possible’. However, it now sates that:
“to place a device on the Great Britain market (England, Wales and Scotland), manufacturers based outside the UK are required to appoint a UK Responsible Person”.
The UKRP still does not need to be the device labeling, until the manufacturer obtains UK Conformity Assessed (UKCA) marking. Per the guidance document:
“the name and address of the UK Responsible Person, where applicable, must be included on the product labelling or the outer packaging, or the instructions for use in cases where the UKCA marking has been affixed. UK Responsible Person details do not need to be included on labelling for CE marked devices, unless the device bears both the CE and UKCA markings”
What does this mean?
Simply put, the old registration & UKRP appointment transition period for devices is over. To be lawfully placed onto the market, all devices must now be registered. And where the manufacturer is not based in the UK, a UK responsible person must be appointed. The UKRP will complete the registration on the manufacturer’s behalf.
No changes were made to the MHRA accepting CE marked devices onto the UK market. That allowance is still in place. As mentioned in the guidance, companies may register leveraging their CE marking until June 30, 2023. Between now and then, companies must obtain UKCA marking and update their registrations accordingly.
June 30, 2023 is a short 1.5 years away. Manufacturers should start giving UKCA marking serious consideration in 2022.