It’s only 17 weeks until the end of the year, which also happens to be the end of the Brexit transition period. We’ve already left the EU and the UK MHRA have been working long and hard to ensure oversight of Medicines and Medical Devices after the current arrangements come to an end.
Yesterday (01 September 2020), the MHRA issued the following important guidance:
Pertinent points have been extracted and are presented below for consideration.
From 1 January 2021 the Medicines and Healthcare products Regulatory Agency (MHRA) will take on the responsibilities for the UK medical devices market that are currently undertaken through the EU system.
For Northern Ireland, different rules will apply to those in Great Britain.
From 1 January 2021, there will be a number of changes to how medical devices are placed on the market in Great Britain. These are:
- CE marking will continue to be used and recognised in Great Britain until 30 June 2023
- Certificates issued by European Economic Area (EEA)-based Notified Bodies will continue to be valid for the Great Britain market until 30 June 2023
- A new route to market and product marking will be available for manufacturers wishing to place a device on the Great Britain market from 01 January 2021.
- The UKCA mark (UK Conformity Assessed) is a new UK product marking that manufacturers will be able to use from 01 January 2021.
- From 01st July 2023, all devices intended to be placed on the UK market must meet the UKCA requirements and place the UKCA mark on the device.
- The UKCA mark will not be recognised on the EU market unless it accompanies the CE mark.
- From 01 January 2021, ALL medical devices and in vitro diagnostic medical devices (IVDs) placed on the UK market will need to be registered with the MHRA. There will be a grace period for registering:
- 4 months for Class IIIs and Class IIb implantables, and all active implantable medical devices
- 8 months for other Class IIb and all Class IIa devices
- 12 months for Class I devices
- Ex-UK device manufacturers will need to establish a UK Responsible Person who will take responsibility for the product in the UK in order that the device may be placed or remain on the market.
- Notified Bodies (NB): If you use a UK-based Notified Body (Term change- ‘UK Approved Body’) to conduct any mandatory third-party conformity assessment for your device, the following will apply:
- If your device is placed on the EU market before 01 January 2021, in accordance with the terms of the Withdrawal Agreement, it may remain on the EU market.
- The results of mandatory conformity assessment carried out by UK Notified Bodies (Approved Bodies) will not be recognised by the EU even if the assessment is carried out before the end of the transition period, unless the product has already been placed on the EU market before 1 January 2021.
- From 01 January 2021, you will no longer be able to place a device on the EU market if your mandatory third-party conformity assessment has been conducted by a UK Notified Body. To place such devices on the EU market, an EEA Notified Body must be used after 31 December 2020.
- Authorised Representatives (AR): Great Britain-based AR’s will not be recognised in the EU from 01 January 2021, regardless of when products were placed on the market.
- If you are a manufacturer based outside the EU and you currently have a Great Britain-based AR, you should make plans to engage an AR based in the EU or Northern Ireland.
- If you are a Great Britain-based manufacturer and wish to continue to supply CE marked devices to the EU market, you will need to establish an AR based in the EU or Northern Ireland, to register and act on your behalf.
If you have any questions concerning these points or for any other devices matter, please contact Matt Burton (matt.burton@jensongroup.com) and he will be pleased to advise and guide you.
This article was written by Medilink EM Patron, JensonR+.