New IVDR Transitional Periods

In January 2022, the European Parliament and the European Council adopted Regulation (EU) 2022/112, which extended the transitional periods for Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDs). This amendment applies to certain IVDs.

The Reason for an Extension of the Transitional Periods.

The extension was adopted in response to the exceptional circumstances associated with significant differences between the IVD Regulation (IVDR) and the IVD Directive (IVDD). However, Regulation (EU) 2022/112 delays the transition timelines for IVDs. The date of application (DoA) of the IVDR will not change and remains the 26^th of May, 2022.

In March 2023, another amendment, Regulation (EU) 2023/607, came into force, eliminating the sell-off period for IVDs.

The Up-Classification of IVDs and the Impact on the Industry Resources.

As a result of the up-classification of IVDs under the IVDR, 80% of the commercially available devices now need to undergo a conformity assessment. Only 6 Notified Bodies (NBs) are designated to work under the IVDR. Therefore increasing the workload for both regulators and manufacturers. The deadline extension provided by Regulation (EU) 2022/112 offers IVD sponsors/companies more time to classify their products, to better plan their product development, accurately carry out the certification procedures, and eventually place the devices on the market. Thus, this extension is expected to help prevent currently in-service, safe IVDs from being discontinued.

What are the new deadlines?

Depending on the risk class, the following deadlines are applied:

• Class A sterile could be placed on the market until the 26th of May, 2027
• Class B could be placed on the market until the 26th of May, 2027
• Class C devices, the transitional period ends on the 26th of May, 2026.
• Class D devices, the transitional period ends on the 26th of May, 2025.

No extension for the following devices:

• Class A non-sterile
• “New” IVD devices (e.g. devices that do not have a signed DoC): the IVDR is applied fully from the 26th of May, 2022.

The potential sell-off is no longer applicable to the IVD Regulation.

Validity of certificates previously issued by a Notified Body under the IVDD – What happens to those certificates issued by NB under the IVDD?

As per Article 110(2) and reference to MDCG’s document (MDCG 2022-6), the deadline changed as follows:

• Certificates issued before the 25th of May, 2017, will remain valid until the date indicated on the certificate. So there is no change.
• Certificates issued before the 25th of May, 2017, per Annex VI of the IVDD, with the involvement of a NB, will become void at the latest on the 27th of May, 2025.

A 1-year extension (previously 2024)

• Other Certificates issued by notified bodies under the IVDD from the 25th of May, 2017, will become void by the 27th of May, 2025 at the latest.

A 1-year extension (previously 2024)

Moreover, there are cases where devices were placed on the market under the IVDD without a NB. This means that the manufacturer issued a Declaration of Conformity (DoC) without the involvement of a NB. With the implementation of the IVDR, an NB is required for the conformity assessment procedures as per the new Rules of the IVDR.

PLG can help navigate all the main references guidelines and their proper application in deploying new or updated requirements to keep the correct compliance applicable to the product in the market.

References:

Regulation (EU) 2017/746 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU

Regulation (EU) 2022/112 of the European Parliament and of the Council of the 25th of January 2022 amending Regulation (EU) 2017/746 as regards transitional provisions for certain in vitro diagnostic medical devices and the deferred application of conditions for in-house devices

New Regulations

The progressive roll-out of the In Vitro Diagnostic Medical Devices Regulation

MDCG 2022-15  Guidance on appropriate surveillance regarding the transitional provisions under Article 110 of the IVDR concerning devices covered by certificates according to the IVDD

MDCG 2022-6 Guidance on significant changes regarding the transitional provision under Article 110(3) of the IVDR

MDCG 2021-18 Applied for scope of designation and notification of a conformity assessment body – Regulation (EU) 2017/746 (IVDR)