Expand Healthcare Consulting  GmbH

Point of Care In Vitro Diagnostics Experts

Contact

Expand Healthcare Consulting GmbH

Point of Care In Vitro Diagnostics Experts

The IVDR Transition Period May Be Extended Beyond May 2022

IVDR extension proposal under discussion

The EU Commission has finally recognised the potential for IVDR to cause significant disruption in the supply of IVD’s and has listened to the increasingly loud clamour for an extension from across healthcare providers and industry.

As a result, the European Commission has proposed to delay the implementation of certain aspects of the In Vitro Diagnostic Medical Devices Regulation (IVDR).

The main reasons given for the extensions include:

  • The notified body bottleneck, caused by the lack of notified bodies (only six currently designated, with a further 11 awaiting designation)
  • The pandemic causing delays in conformity assessments by notified bodies
  • The change from currently 8% to 80% of all IVD devices requiring notified body certificates with the IDVR implementation
  • The time to complete the assessment (1 year plus six months to manufacture, before releasing to the market).

In the proposed amendment, IVDR will remain fully applicable from 26 May 2022, but would extend the transitional period for obtaining certificates and placing an IVD device on the market.

The extensions depend on whether an IVD device has a certificate under IVDD (Vitro Diagnostic Medical Devices) and/or requires one under IVDR. In addition, the dates by which health institutions are to meet their new requirements for exemption have similarly been extended. Under the proposal, the regulation’s 2-year transitional phase would be extended by 1 to 3 years, according to the risk category of the device.

The proposed transition periods to undergo a conformity assessment for the first time are the following:
  • High-risk class D devices would be extended one year, i.e., to May 2025.
  • Moderate-risk class C devices will have until May 2026.
  • Class B and Class A sterile diagnostics would have until May 2027.

Devices not requiring any notified body certificates and placed lawfully on the market before 26 May 2022 might continue to be made available or put into service until 26 May 2025. To take advantage of this provision, manufacturers will need to stockpile devices “placed on the market” ahead of 26 May 2022.

The proposal now heads to the European Parliament and Council for adoption and will take effect upon publication in the Official Journal of the European Union.

IMPORTANT
Manufacturers should note that, even if they can take advantage of transitional provisions, they must still comply from 26 May 2022 with IVDR provisions on post-market surveillance, market surveillance, vigilance, and registration of economic operators and devices. In addition, non-EU manufacturers will also need to appoint an importer from 26 May 2022.

Finally, one must note that this is a proposal and until the European Parliament and Council approve it, the original text remains the law.

Guidance for Classification Rules for IVDR can be found here.
The IVDR Transition Period May Be Extended Beyond May 2022