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UKCA, MDR2002 and why May 2025 is so important

The MHRA have provided a further update to the implementation of the future regulation of IVDs in Great Britain on the 16th June 2023. This follows on from earlier updates pushing back the timelines for UKCA marking for IVDs.

Here are the key timelines for placing IVDs on market in Great Britain:

When using CE marking

  • In Vitro Diagnostic Medical devices (IVDs) compliant with the EU in vitro diagnostic medical devices directive (EU IVDD) can be placed on the Great Britain market up until the expiry of certificate, or 30 June 2030. This is only applicable for devices where a declaration of conformity has been drawn up prior to 26 May 2022
  • IVDs compliant with the EU in vitro diagnostic medical devices regulation (EU IVDR) can be placed on the Great Britain market up until the 30 June 2030.

For devices continuing to utilise the IVD Directive certification (IVDD List A, List B or Self-test devices): while in practise, the 30 June 2030 offers a long lead-time, in reality this is dependent on the expiry of your CE certification. Article 110 of the IVDR states that IVDD CE certificates can be used up to their expiry or until 27 May 2025. Beyond that date, devices which have an IVDD Certificate can not be placed on market in either the UK or EU.

General IVDs under the IVD Directive, for which the conformity assessment did not require a notified body, can only be placed on the Great Britain market if the involvement of a notified body would be required under the IVDR (Class A Sterile, B, C, D) up until 30 June 2030, taking into account the IVDR transition dates applicable for each device class.

What are the deadlines for EU IVDR (2017/746/EU)?

The transition dates are as follows:

26 May 2022 – Class A, New devices

26 May 2025 – Class D devices

26 May 2026 – Class C devices

26 May 2027 – Class B, Class C Sterile

This has been explained in an info graphic by the MHRA.

When using UKCA Marking

Devices can now be placed on the UK market under a UKCA. Currently, this can be completed under the existing MDR2002 (similar to the EU IVD Directive). From the 26 May 2025, all new devices placed on market under UKCA will be required to meet the new regulatory framework, which is due to be published later this year.

It is expected that devices placed on market under the UKCA before 25 May 2025, must comply with the new regulatory framework from 30 June 2030.

The transition process above gives the industry an opportunity to benefit from the use of the existing UK MDR (IVDD) framework, where general devices can continue to use self-declaration before the deadline (707 days to go!!) While progress can be made on compliance to EU IVDR.

Further Updates

Further information will be provided regarding Post Market Surveillance requirements (expected in the next 3-6 months) and the full draft regulation at the end of 2023 – early 2024.

We encourage IVD manufacturers to review their device portfolios, classification and certification against the timelines above, and start preparing for the transitional process. IVDeology are currently supporting a number of international companies through the IVDR and UKCA transition. For more information on how we can support you, book a call with Casey or e-mail [email protected].