European Commission Extends IVDR Transition Period

Huge news (and relief) for the IVD industry as the European Commission proposes an extension to transition timelines for the IVDR. With up to 80% of IVD manufacturers engaging with a notified body for the first time and only six designated so far, this extra grace period is a step in the right direction as we recover from the COVID-19 pandemic.

Please note that the IVDR DATE OF APPLICATION HAS NOT CHANGED therefore IVDR vigilance and PMS requirements apply from May 26, 2022. There are also some caveats to the transition extension.

Excluded are IVDs that do not require a notified body under IVDR, i.e. non-sterile Class A products. They must already be compliant with the IVDR from May 27, 2022. These are analytical instruments, non-sterile sample containers and other laboratory equipment. Also excluded are new developments for which manufacturers issue a declaration of conformity after the date of application of the IVDR.

Manufacturers who were able to self-declare conformity under the IVDD but require a notified body under the IVDR may continue to place IVDs on the market until the dates below (with a corresponding postponement for sales by 1 year).

However, the prerequisites are that the manufacturer:

  • Had already issued a declaration of conformity according to IVDD before May 26, 2022
  • Will not introduce any significant changes to the design, manufacture or intended purpose
  • Established post-market surveillance (Articles 78-81, Annex III) and vigilance (Articles 82-87) according to the IVDR
  • Registers in EUDAMED according to the IVDR

For many manufacturers of assays and analysis software, however, it will be difficult to do without significant changes. Both analytes and requirements for threshold values for their detection are constantly changing. Likewise, PMS and vigilance and its interfaces (e.g. risk management, usability) are not or only insufficiently established with many IVD manufacturers.

Below are the new transition dates proposed after all above caveats have been considered:

  • May 26, 2025 for Class D devices
  • May 26, 2026 for Class C devices
  • May 26, 2027 for Class B devices
  • May 26, 2027 for Class A sterile devices
  • May 26, 2022 for non-sterile self-declared devices
  • May 26, 2022 for all new devices

NSF advises the industry to not lose momentum in still preparing for May 26, 2022.

We can help you navigate the process, from training and preparation of your technical files to consulting, technical file remediation, performance evaluation reports, and more.

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