Is IVDR Necessary?

The In Vitro Diagnostic medical devices Regulation (IVDR) will supersede the In Vitro Diagnostic medical devices Directive (98/79/EC) (IVDD). The IVDR is the new regulatory basis for placing on the market, making available and putting into service in vitro diagnostic medical devices on the European market. It will replace the EU’s current Directive on IVDs. As a European regulation, it will be effective in all EU member states and EFTA states immediately without any need to be transferred into the law of respective states. However, national laws may be adapted to back up some requirements in more detail.

The IVDR came into effect on 25 May 2017. Several implementing acts/guidance documents are being issued by the EU commission and are stipulated to complete some of the requirements to be met. The IVDR Date of Application is 26 May 2022. After the stipulated date, all new (i.e. not previously placed on the market) IVDs and class A self-declared devices will have to meet the requirements of the IVDR in order be marketed in the European market.

However, an extended transition period is possible for products already on the EU market prior to 26 May 2022.

a) Devices placed on the EU market prior to 26 May 2022 as self-declared (i.e. with no notified body involvement) and that require the involvement of a notified body under the Regulation, may be placed on the market or put into service under the Directive until the following dates:

b) 26 May 2025, for class D devices;

c) 26 May 2026, for class C devices;

d) 26 May 2027, for class B devices and class A devices placed on the market in sterile condition.

Devices placed on the EU market prior to 26 May 2022 with notified body certificate, may be placed on the market or put into service under the Directive until 25 May 2025.

In terms of their impact on manufacturers and products, the IVDD and the IVDR largely share the same basic regulatory process. No existing requirements have been removed, but the IVDR adds new requirements.

The IVDR brings more stringent requirements for the designation of Notified Bodies, with increased control and monitoring by the national competent authorities and the Commission.

The IVDR also strengthens the requirements for clinical evidence and conformity assessment. For companion diagnostics, the NBs shall consult the competent authorities for medicinal products (Article 48).

The IVDR calls for increased transparency, with the information on IVDs and ‘higher risk’ performance studies being made public through the  new European Database for Medical Devices (EUDAMED), which will play a pivotal role in providing a  complete, accurate and accessible data to the concerned parties.

The introduction of a unique device identifier (UDI) for every IVD device will significantly enhance traceability and support post-market safety activities.

Compared to the IVDD, the IVDR provides more importance on the life-cycle management and continuous evaluation of products.

The IVDR requires manufacturers to show that they have an effective quality management system (QMS) in place.

Now most of the IVD devices are required to comply with IVDR, KN consulting will help in the smooth transition of the product compliance to IVDR.