06 Jul Navigating the post-Brexit regulatory landscape: UKCA Mark changes

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Navigating the post-Brexit regulatory landscape to ensure compliance when placing products on the UK market can be difficult, with numerous challenges to overcome. From July 2023, European CE marking on medical devices will no longer be accepted on the market in the UK and will be replaced by the UKCA mark. The UK Medicines and Healthcare products Regulatory Agency (MHRA) will also update current UK Medical Devices Regulation (UK MDR) with the focus on delivering improved patient and public safety, greater transparency, and more proportionate regulation of medical devices.

Between September and November 2021, the MHRA consulted on proposed changes to the regulatory framework for medical devices in the United Kingdom (UK). The consultation sought the views of patients, medical device researchers, developers, manufacturers and suppliers, clinicians, other healthcare professionals and the wider public to help shape our future approach to regulating medical devices in the UK.

It contained 15 technical chapters divided in 74 section with related proposals. For each proposal the respondents could be in favour/supportive, not in favour/not supportive or don’t know/have no opinion. Respondents were asked to set out their reasoning for their response to the each question. The government received 891 consultation responses: 413 from individuals and 451 from organisations. Last month the UK government published their response to consultation. For each section the document brings the proposal/feedback and the government response.

Having considered all responses and feedback it is the government intention to proceed with most of the changes proposed. A few requirements will be further considered and a small number of suggestion regarding implantable devices will not be taken forward at this time. The government will also include a publication of guidance on new requirements.

The new regime will not affect only manufactures but also importers, distributors and health institutions, as it is the MHRA intention to introduce new obligations to these economic operators. Most requirements will align with the EU MDR and the government is focused on establishing a more comprehensive registration database for medical devices, which will include UDI information. The approach to the Clinical Investigation and Performance studies would take the requirement beyond the equivalence requirements in the EU MDR.

The transition to new arrangements by 1st July 2023 was also considered and we are pleased to see that the Questions around Conformity Assessment Body capacity and process readiness have been addressed.

It is the MHRA intention to introduce the following transitional arrangements:

  • For UKCA marked devices that hold a valid certification/declaration of conformity to the UKCA standard or CE Marked devices under MDD, IVDD, AIMDD valid  before the new regime takes full effect
    • General Medical Devices: three years or until the certificate expires whichever is sooner
    • IVD: five years or until the certificate expires whichever is sooner
  • For CE Marked devices under MDR
    • allow products to continue to be placed on the market until either the certificate expires or for five years after the new regulations take effect, whichever is sooner
    • This will apply even if the certification/declaration of conformity is dated after the new regulations take effect.
  • The caveats that will apply to are: 
    • devices that are subject to significant changes in design or intended purpose will be excluded from these provisions 
    • all post-market requirements applicable to the new regulatory framework will need to be complied with for all products which benefit from the transitionary arrangements

Full details of these changes and the latest government guidance can be found here: https://bit.ly/3R8M9pZ

For more information, guidance or assistance with #UKCA marking or product compliance, please get in touch with our regulatory specialists by emailing info@orthocg.com or visiting our QARA dedicated page here.