Deadline for mid-risk device classes almost here: 1 September 2021 for Class IIb non-implantable, Class IIa, Annex II, List B IVDs, self-test IVDs
The United Kingdom has left the EU, and 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.
If you have not already done so, we strongly encourage you to submit the UK registration process for these devices. The MHRA has given a 6-day turnaround to process applications. However, it is possible the timeframes could exceed the six days if there is a rush of applications submitted at the last hour. Especially as this ‘batch’ of device classes are much higher in volume than the 1 May 2021 deadline for highest risk class devices: Class III, AIMD, Class IIb implantable and Annex II, List A IVDs. Many more submissions will need to be processed as this deadline approaches.
If you have high 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.