Industry Update: Interesting news on – BREXIT and Medical Device Registration

As of January 1, 2021, the UK’s departure from the EU will begin.

As of that date, the Medicines and Healthcare products Regulatory Agency (MHRA) will take on the responsibilities for the medical devices market for the UK that are currently undertaken through the EU system.

This calls for several changes to how medical devices are placed on the market in Great Britain:

• CE marking will continue to be recognized in Great Britain until 30 June 2023
• Certificates issued by EU-recognized Notified Bodies will continue to be valid for the Great Britain market until 30 June 2023
• After the transition period, the EU will no longer recognize UK Notified Bodies
• UK Notified Bodies will not be able to issue CE certificates (other than for the purposes of the “CEUKNI” marking, which will be valid in Northern Ireland) – and will become UK Approved Bodies from 1 January 2021
• From 1 January 2021, all medical devices, including 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:
  • Class IIIs and Class IIb implantable, and all active implantable medical devices and IVD List A products must be registered from 1 May 2021
  • Other Class IIb and all Class IIa devices and IVD List B products and Self-Test IVDs must be registered from 1 September 2021
  • Class I devices, custom-made devices and general IVDs (that do not currently need to be registered) must be registered from 1 January 2022
  • It will be possible for manufacturers to register devices of different classes, that are subject to different grace periods, at the same time. For example, manufacturers (or their UK Responsible Person) will be able to register their Class IIa medical devices at the same time as registering their Class III medical devices. In this particular case, devices would need to be registered from 1 May 2021 in line with the grace period for registering Class III devices.
• Manufacturers of Class I devices, custom-made devices and general IVDs that are currently required to register their devices with the MHRA must continue to register their devices from 1 January 2021 on the same basis as they do now until the new registration requirements start to apply to those devices
• If you are a manufacturer based outside the UK and wish to place a device on the Great Britain market, you will need to appoint a single UK Responsible Person who will take responsibility for the product in the UK.

For manufacturers outside the UK, the full responsibilities of the UK Responsible Person are set out in UK MDR 2002. In summary:

• Ensure that the declaration of conformity and technical documentation have been drawn up and, where applicable, that an appropriate conformity assessment procedure has been carried out by the manufacturer.
• Keep available a copy of the technical documentation, a copy of the declaration of conformity and, if applicable, a copy of the relevant certificate, including any amendments and supplements for inspection by the MHRA.
• In response to a request from the MHRA, provide the MHRA with all the information and documentation necessary to demonstrate the conformity of a device.
• Provide samples of a device to the MHRA or allow the MHRA access to the device where the UK Responsible Person has samples or access or, where they do not have access or samples, forward to the manufacturer any request from the MHRA for samples or access.
• Cooperate with the MHRA on any preventive or corrective action taken to eliminate or, if that is not possible, mitigate the risks posed by devices.
• Immediately inform the manufacturer about complaints and reports from healthcare professionals, patients and users about suspected incidents related to a device for which they have been designated.
• Terminate the legal relationship with the manufacturer if the manufacturer acts contrary to its obligations under the applicable Regulations and inform the MHRA and, if applicable, the relevant Notified Body of that termination.

From 1 January 2021, the name and address of the UK Responsible Person, where applicable, will need to be included on product labelling where the UKCA mark (Required from 1 July 2023 onwards) has been affixed. UK Responsible Person details will not need to be included on labelling for CE marked devices.

This is another level of compliance to market your medical device in the UK. Keep up with these regulations can be very burdensome.

For any assistance with medical device registration through the UK please email, mdi Consultants at [email protected] RE: MHRA.