10 things to know about medical device regulation post Brexit

The twin forces of the new EU Medical Device Regulation and Brexit and how you can prepare.

As if the spectre of Brexit and navigating a global pandemic were not enough to contend with; with only 5 months left to the end of the transition period to the new EU MDR, it’s time to assess the impact to your business and take decisive action.

We’ve helped break it down to the 10 most important regulatory changes to be aware of for businesses wishing to place medical devices on the GB and NI markets.

  1. The UK Government have confirmed that the new IVDR / MDR regulations will not apply to Great Britain but will apply to Northern Ireland from 26th May 2021 and 26th May 2022 respectively as per the EU’s implementation timeline.  Devices CE marked in compliance with existing directives AND the incoming regulations (MDR/IVDR) can continue to be placed on the GB market until the 30-Jun-2023.
  2. Companies must designate a UK responsible person from 1st Jan 2021. This can be a person or a business.  ARC Regulatory, as a Northern Ireland-based entity, are already offering this service, as well as EU Authorised Rep services, to a limited number of manufacturers.  Please reach out if you would like to explore this option with us too.
  3. From 1st July 2023, a new UKCA mark will replace CE marking.    
  4. The UKCA mark will be based on UK MDR 2002 as they exist at the end of the transition.  Manufacturers may therefore choose to use the UKCA or CE mark for placing devices on the GB market from the 01-Jan-2021.
  5. All devices need to be registered with MHRA. (Businesses will be given a grace period for new registrations). If your device is already registered, you don’t need to re-register.
  6. The government is setting up a new domestic UK database to replace the EU’s NANDO (New Approach Notified and Designated Organisations) Information System.
  7. UK Notified Bodies will not be able to conduct conformity assessments in relation to the CE marking other than for the purposes of the “CE UKNI” marking, which will be valid in Northern Ireland.  This is a provision for a GB based manufacturer who can place their device in the NI market but not beyond.
  8. If you plan on exporting goods to Northern Ireland, MDR/IVDR will apply in N.I. like EU.
  9. From 1 January 2021, to place a CE marking on your device for circulation in both Northern Ireland and the EU, you must use an EU-recognised Notified Body to undertake any mandatory third-party conformity assessment. The results of conformity assessments carried out by UK Notified Bodies will not be recognised within the EU.
  10. In addition to the CE marking, device manufacturers will also need to apply the UKNI marking if they choose to use a UK Notified Body for mandatory third-party conformity assessment. Device manufacturers will never apply the UKNI marking on its own – it will always accompany a CE marking. However, to place goods on the EU market, manufacturers must use the CE marking on its own, without the UKNI marking.

In summary, you need to use the UKNI marking if:

  • you are placing certain medical devices on the Northern Ireland market after the end of the transition period; and;
  • your goods require mandatory third-party conformity assessment; and
  • you are planning to use a UK body to carry out those conformity assessments after the transition period

The UKNI marking is sometimes referred to as the UK(NI) mark or the UK(NI) indication, including in Article 7(3) of the Northern Ireland Protocol. These terms refer to the same marking.

For additional background, view our post which discusses the regulations pertaining to NI in detail.

With Brexit news coming every day and yet another extension to the negotiations, planning is difficult for everyone.  Stay tuned for news on our webinar in the New Year with all of the latest updates.