MHRA Guidance on regulating Medical Devices

On 1 September MHRA published its Guidance on Regulating medical devices from 1 January 2021, thus after the Brexit transition period ends. The UK will have its own regulatory regime as of 1 January 2021, and it will include a number of changes to how medical devices and IVDs are placed on the market in Great Britain.

The key changes are:

  • CE marking will continue to be used and recognised until 30 June 2023.
  • Certificates issued by Notified Bodies based in the European Economic Area will continue to be valid for the Great Britain market until 30 June 2023.
  • From 1 January 2021:
    • A new route to market and product marking (the UKCA mark) will be available for manufacturers wishing to place a device on the Great Britain market. 
    • Medical devices placed on the Great Britain market will need to have either a UKCA mark or a CE mark on their labelling, depending on which legislation the device has been certified under.
    • All medical devices and in vitro diagnostic medical devices placed on the market in Great Britain will need to be registered with the MHRA. There will be a grace period for registering.
    • If you are a manufacturer based outside the UK and wish to place a device on the market in Great Britain, you will need to designate a UK Responsible Person that is established in the UK.

As of 1 January 2021, Great Britain will be considered a third country, thus, from this date forward the EU rules for importing products from third countries will apply.
This implies that from 1 January 2021:

  • Devices may no longer be placed on the European market if the third-party conformity assessment has been conducted by a UK-based Notified Body.
  • Device manufacturers based in Great Britain will need to appoint an EU-based Authorised Representative in order to enter the European Market
  • Device manufacturers currently using an Authorised Representative based in Great Britain in order to enter the European market will have to transfer to an EU-based Authorised Representative.
  • Device labelling must meet all EU labelling requirements in order to place it on the EU market.

For Northern Ireland, different rules will apply to those in Great Britain after the transition period.

What does this mean to you?

If you are established outside of the UK and wish to continue placing your devices on the market in Great Britain, you will have to establish an action plan to meet all the new requirements. If you are established in Great Britain, then you will have to urgently take the necessary actions to ensure full compliance to the EU requirements if you wish to continue placing devices on the EU market.

Should you want to discuss this more in depth with one of our consultants, please do not hesitate to get in touch with us.

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