January 9, 2019
Peace for our time? Will medical device trials remain the same after a no-deal Brexit?
The UK Government, more precisely the MHRA, had a productive start of the new year 2019 with a new guidance for medical device trials in the UK in case there is a Brexit with no-deal (published on the 3rd January and changed on the 4th January 2019).
The guidance in short: no worries, everything will remain the same. Sounds familiar?
Medical devices in the UK are currently regulated by the Medical Devices Regulations 2002 through transposition of the MDD, AIMMD and IVDD in the UK law. In case there is no deal (and even if there is!) the MHRA is responsible for the UK market according to this MDR 2002. The guidance proposes how the UK system should operate in case there is a no-deal Brexit.
- For an unspecified time CE-certificates from non-UK-based Notified Bodies will remain valid.
- Although UK-based Notified Bodies will lose their EU recognition the MHRA will continue to recognize the validity of their CE-certificates after 29th March 2019. In other words: all medical devices with a valid CE-certificate can remain on the UK market (for the time being!)
- There will be no changes to clinical trials with medical devices as the UK will continue to recognize existing approvals (both regulatory and ethics approvals) with no need to re-apply.
- Applications for new medical device trials will remain the same both for MHRA and Ethics Committees. In other words: everything will stay as is (for the time being!) for current and new Clinical Investigations with Medical Devices
No matter what a no-deal Brexit will bring, the intention is to adapt the Medical Devices Regulations 2002 so it will ‘mirror’ the key elements of the MDR and IVDR. These adaptations will keep pace with the same timelines as the EU.
After the Brexit (currently scheduled for 29th March 2019) medical device manufacturers must register their active, non-active and in-vitro devices with the MHRA before they are allowed on the UK market. As this is regarded as an extension of existing registration a grace period will be allowed for compliance. The higher the risk class of the device, the shorter the grace period.
- 4 months for Class III medical devices, Class IIb implantable medical devices, Active implantable medical devices, and IVD List A
- 8 months for Class IIb non-implantable medical devices, Class IIa medical devices, IVD List B, Selftest IVDs
- 12 months for Class I medical devices, Self-certified IVDs, Class A IVDs
Important to realize is that after a no-deal Brexit a manufacturer with a medical device on the UK market needs to be registered with the MHRA through a ‘UK Responsible Person’ whom is established in the UK (including an UK registered address). This ‘UK Responsible Person’ will take responsibility for the product in the UK. Any consolation may be that no labelling changes will be required to reflect the role of this ‘UK Responsible Person’.
Source: https://www.gov.uk/government/publications/further-guidance-note-on-the-regulation-of-medicines-medical-devices-and-clinical-trials-if-theres-no-brexit-deal/further-guidance-note-on-the-regulation-of-medicines-medical-devices-and-clinical-trials-if-theres-no-brexit-deal 08Jan2019 16:00hrs