UK medical device regulator proposes 12-month delay for UKCA requirements and new medical device regulations | McDermott Will & Emery

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On Friday 21 October 2022, the Medicines and Healthcare products Regulatory Agency (MHRA) wrote to the medical device industry to explain its intention:

  • Extending the current twelve month standstill period from July 2023 to July 2024. This means that valid CE marks would continue to be accepted in Great Britain (GB) and the requirement to obtain a UK Conformity Assessed mark (UKCA ) has been postponed until July 2024; and
  • Introduce the new medical device regulations in July 2024.

This news will come as a welcome relief to manufacturers in the sector following widely published reports of a backlog in the processing of UKCA applications to approved bodies across the UK.

It is important to note that the extension is not yet confirmed in law, so we expect further updates to the MHRA website and new legislation to be released.

This extension was widely expected following delays in the implementation of the new regulatory framework for medical devices.

Specific details of the UK’s new medical device framework have yet to be released following the UK government’s consultation on the proposed changes that began in 2021. The government answer to the consultation published in June 2022 indicated that the new UK Medical Device Regulations will be closely aligned with the EU Medical Device Regulations 2017.

The MHRA’s implementation schedule initially called for the consultation response for the new framework to be published in March 2022 with the regulations tabled in parliament by the end of June 2022. Under World Organization rules (WTO), the MHRA is also required to notify the WTO and the WTO must publish the draft regulations for a period of at least 60 days for comment before the regulations are filed.

The MHRA said it was continuing to work on developing future regulations. The likely timeline seems to be:

  • Notification of new regulations on medical devices to the WTO: early 2023
  • New regulation on medical devices submitted to parliament: spring 2023
  • New Post-Market Surveillance Requirements: Spring 2023
  • Entry into force of the new regulations on medical devices: July 2024
  • Start of the calendar for the new transition periods: July 2024.

The government’s response in June 2022 indicated that there would be quite generous transition periods in the new medical device framework. The response indicated that the arrangements would, at a minimum, allow products to be marketed as follows:

  • General medical devices: until the certificate expires or for three years after the entry into force of the new regulations (whichever comes first); and
  • In vitro diagnostics: until the expiry of the certificate or five years after the entry into force of the new regulations (whichever comes first).

These transitional provisions would not apply in the event of major changes in design or destination. In addition, any products that benefit from transitional provisions will likely need to comply with post-market requirements.

In its letter dated 21 October 2022, the MHRA also acknowledged the shortage of approved bodies in the UK and noted that it was working proactively with six organizations which have applied to become approved bodies in the UK. Currently, there are only four accredited bodies in the UK.

This news also comes the week the MHRA also issued guidance on Software Modification Program and AI as a Medical Device Roadmap setting out proposals to implement new legislation and additional guidance aimed at clarifying what medical device requirements mean in the context of software and AI and aligning more closely with global rules such as the IMDRF.

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