Transitional provisions for certain in vitro diagnostic medical devices (IVDR 2017/746)

Proposal for transitional provisions for certain in
vitro diagnostic medical devices under Regulation (EU) 2017/746

European Commission issued a proposal (2021/0323 (COD)) for the amendment of the transitional provisions under EU Regulation 2017/746 on in vitro diagnostic medical devices (IVDR).  Once approved by the council and parliament this will give more time for many IVD manufacturers to comply with the IVDR.

In this case for the up classified (A sterile, B,C,D) devices for which the conformity assessment procedure pursuant to Directive 98/79/EC did not require the involvement of a notified body and for which a declaration of conformity was drawn up prior to 26 May 2022 in accordance with the Directive  98/79/EC,  the following dates will apply.

Class D – 26 May 2025

Class C –  26 May 2026

Class B  – 26 May 2027

Class A sterile – 26 May 2027

This proposal does not cover the new devices which will be put on the market after 26 May 2022 and class A devices. So the new comers and class A devices has to comply with IVDR at the date of application 26 May 2022.

IVDR Risk Classification

Article 47 of the IVDR EU 2017/746 defines four new risk classes (A, B, C, D) considering the intended purpose of the devices. As an IVD manufacturer you should review the 7 classification rules given on Annex VIII of the IVDR and define the risk class of your device.

Compared to 98/79/EC IVD Directive (IVDD) the classification of the devices is one of the most important changes which manufacturers must comply during IVDR transition. The rigid classification system of IVDD now becomes a flexible IVDR Risk Classification system which enables room for new devices and technology developments.

In the good old days, most the IVD devices could be marketed with a self-declaration without a Notified Body intervention. Only List A, List B and self-test devices were required to go through a conformity assessment procedure via a Notified Body.

The IVDR is now changing the game by increasing the Notified Body intervention during the conformity assessment procedures. Therefore, many manufacturers will go through a certification process for the first time. Considering the low number of available Notified Bodies and transition timelines, this seems to be real challenge for many mid-sized manufacturers.  

The MDCG 2020-16 Guidance brings clarification to the IVDR Risk Classification rules listed on Annex VIII. The guidance document includes rationale and examples (non-exhaustive) for each IVDR Risk Classification rule. Apart from the examples the initial paragraphs of the guidance document gives a very good summary about the principles of classification.

For details about IVDR and support to classify your IVD, you can consult our experts.