This Year So Far

EU officially extends the MDR transition period for legacy devices

It is postponed from 26 May 2024 to:

• • 31 December 2027- Class IIb implantable and Class III devices
  • 31 December 2028 – Class IIb (all other), Class IIa, Class I sterile/measuring and MDD Class I self-certified devices up-classed under the MDR

The extension only applies to MDD/AIMDD legacy devices. Devices new to market are out of luck and must comply with the MDR prior to marketing.

For more information read: MDR Transition Extension Guide

Switzerland and UK follow to accept the MDR transition extension

Swissmedic and the UK MHRA quickly publish confirmations that they will recognize the EU MDR’s extension, and those qualifying devices may continue to be placed onto their respective markets.

MHRA announces new UK regulation to be further postponed (now 2025)

The MHRA announces that the new UK Regulation will now have a target date of July 2025. It was originally intended to be released in July 2023, and then July 2024.

The current UK Medical Device Regulation (UK MDR 2002) is based on the old EU Directives: MDD/AIMDD/IVDD. The new regulation would overhaul the current system, adding more robust requirements. Those proposed requirements are to be similar, but not exact, to the EU MDR/IVDR.

Further, the MHRA announced its intention to continue recognizing CE Marked devices for a longer period in Great Britain:

• • MDD/AIMDD CE Marked legacy devices – until 30 June 2028 or the CE Certificate expires
  • IVDD CE Marked legacy devices – until 30 June 2030 or the CE Certificate expires
  • MDR/IVDR CE Marked devices – until 30 June 2030 or the CE Certificate expires

In the meantime, manufacturers must still register their devices prior to marketing in Great Britain. Non-UK companies must appoint a UK Responsible Person (UKRP) and the UKRP will complete the registration on their behalf.

Swiss deadline for IVDs to appoint Authorized Representative

The deadline for Class D (31 December 2022) and Class B and C (31 March 2023) IVDs to appoint a Swiss Authorized Representative (AR) passes.

The final deadline for Class A IVD manufacturers is approaching (31 July 2023). After this date, all non-Swiss and non-Lithuanian manufacturers must have a Swiss AR appointed to continue marketing.

EU releases the following guidance

MDCG 2023-3: Q&A on MDR Vigilance Terms and Concepts

MDCG 2020-3 Rev. 1: Updates to MDR significant Changes Guidance

Whatever happened with ….?

The UK’s legislative update to officially postpone UKCA Marking?

It was published on 9 June 2023 and comes into force on 1 July 2023: HERE 

The UK’s new Post-Market Surveillance Requirements?

You may recall that the MHRA was intending to release new post-market surveillance (PMS) requirements in the Spring of 2023.

The statutory instrument (i.e., legislation) is expected sometime this Summer and the anticipated implementation date is Winter of 2023/Early 2024.

NOTE: the new PMS requirements are expected to impact all devices, i.e., even those that are registered based on CE Marking will be expected to comply with the MHRA’s new PMS requirements.

Swiss Parliament’s decision in 2022 to accept US FDA devices onto the Swiss market?

Currently, no movement we can see publicly. The most current information published by Swissmedic is:

“The FOPH is currently examining how this motion can be implemented without compromising patient safety. To this end, clarifications and preparatory work are required.The current legislation on medical devices remains in force.”

NOTE: the UK MHRA also announced similar intentions to recognize devices from ‘trusted’ regulators (e.g., US FDA) earlier this year. However, that was early-stage planning, and we expect more time for a more formal proposal to be released in the UK. This is unlike Switzerland, which has been requested by the Swiss Parliament to move on the vote to accept FDA devices, as well as lobbying efforts for swifter action by Swiss MedTech.

The Swissdamed registration database?

No further news has been released since Swissmedic announced in September 2022, that “Swissdamed” would be released sometime in 2023. Until Swissdamed goes live, only:

• • Swiss-based Economic Operators (i.e., manufacturers, authorized representatives and importers) require registration.
  • Swiss-based Manufacturers are subject to local medical device and IVD registration requirements. 
    • Except custom-made devices, which require registration irrespective of where the manufacturer is located.

MDCG’s list of Guidance to be released in 2023?

The MDCG issued a list of proposed new guidance documents, as well as amendments to a fair number of existing documents.

For example, new documents proposed for 1^st half of 2023 included:

• • New guidance on Post-market Surveillance Requirements and Harmonized Reporting Forms for Incidents
  • Amended guidance on: MDCG 2021-17 on Importers & Distributors and MDCG 2019-7 on Persons Responsible for Regulatory Compliance

To date, these are still pending release.