The deadline for low-risk device classes is nearing fast:  1 January 2022 for Class I devices and General IVDs

The United Kingdom has left the EU, and has developed its own registration system, separate from Europe’s registration system. The MHRA has given a total one-year transition timeframe to comply, with staggering the registration deadlines based on device classification.

This is the last and final opportunity for low-risk devices to be registered within the one-year transition deadline. The high-risk registration deadline passed on 1 May 2021 and the mid-risk registration deadline passed on 1 September 2021.

Class I medical devices and General IVDs may have been registered at any time within 2021. Companies did not have to wait until 31 December 2021 to register. However, if you have not registered your low-risk devices yet, now is the time to do it.

The MHRA has given a 6-day turnaround to process applications. However, they experienced a several month delay during the mid-risk deadline, due to so many applications being submitted in the final month. The MHRA has asked industry to submit the low-risk device applications early, as to not cause the same slow-down as occurred for the 1 September 2021 deadline. Companies should also factor in office closures and reduced staff due to the upcoming holiday season.

If you have low risk devices and are actively placing them onto the UK market, we strongly recommend you start the registration process now, if you have not already done so. If you are a non-UK based company, you must contact your UK Responsible Person to complete the registration on your behalf.