On 01 September 2020, the Medicines and Healthcare products Regulatory Agency (MHRA) laid out the future UK requirements on device certification, conformity marking and registration with the agency.
Medical devices will be regulated under the Medical Devices Regulations 2002, which currently transpose the European directives (90/385/EEC, 93/42/EEC and 98/79/EC), pending UK specific modifications.
A new regulatory framework will be introduced for the UK from 1 January 2021, resulting in the UK Conformity Assessed (UKCA) mark. However, CE marking and EU-based Notified Bodies (NB) certificates will continue to be recognised until the end of June 2023.
The MHRA will designate UK Approved Bodies to conduct assessment for the UKCA mark, although any UK NB designated under the current directives (MDD/AIMDD/IVDD) will not need a new designation process.
Devices placed on the UK market will need to first be registered with the MHRA. Non-UK manufacturers must also assign a UK Responsible Person (UKRP). There is a grace period for these notifications based upon classification, but the highest risk products need to be registered by April 2021:
- Four months: Active implantable medical devices, Class III medical devices, Class IIb implantable medical devices, IVD list A
- Eight months: Class IIb non-implantable medical devices, Class IIa medical devices, IVD list B, Self-test IVDs
- 12 months: Class I medical devices, General IVDs.
In Northern Ireland (NI), the UKCA mark will not be recognised, therefore EU devices in this market will still require CE marking. A CE UK (NI) mark will also be introduced specifically for this market. The EU Medical Device Regulation (MDR) and In-Vitro Device Regulation (IVDR) will apply in NI to align with the EU’s implementation timeline. A CE UK (NI) mark will also be introduced specifically for this market. Furthermore, a UKRP will be required if the manufacturer is located in the EU, EEA or third country.
Of most significance is the fact that the MDR and IVDR will not automatically apply in Great Britain as they will not take effect in the EU until after the transition period expires. Further discussions and consultations with stakeholders and the public will take place before the end of 2020.
To view the full guidance, click here.