Amendment for the transition of in vitro diagnostic medical devices (IVDs) to the EU 2017/746 (IVDR)

By the end of 2021, the European Commission prepared an amendment for the in vitro diagnostic medical device (IVD) regulation. This amendment aims to extend the scope and timelines for the transition to the new regulation and thus avoid the disruption in the supply of IVDs on the European market.

The European IVD Regulation (IVDR 2017/746) will become exclusively applicable from May 26, 2022, thus repealing the previous directive (98/79/EC). That regulation introduces numerous changes to the classification of devices. Approximately 80% of IVDs may now require the assessment of notified bodies before being placed on the market (compared to the 8% under the directive). However, the number of notified bodies remain pretty limited (6 so far), and together with the difficulties arising from the COVID-19 pandemic, it has resulted in the collapse of such bodies and the prediction of a lack of IVDs on the market. Given that 70% of clinical decisions are made using these devices, inaction by the European authorities was unacceptable.

Consequently, the European Commission has drafted an amendment to the regulation to extend the number of devices eligible for a "soft" transition. In this way, IVDs placed on the market under Directive 98/79/EC and requiring the involvement of a notified body under the new regulation will be able to continue to stay on the market until the following dates:

• May 26, 2025, for Class D devices.
• May 26, 2026, for class C devices.
• May 26, 2027, for Class B and Class A sterile devices.

However, IVDR's requirements for post-market surveillance, market surveillance, vigilance and registration of devices and economic operators must be applied from May 26, 2022.

¿How can AKRN help?

In AKRN Scientific Consulting, we are experts in clinical research and regulatory services for MedTech Industry, with experience supporting manufacturers transitioning to IVDR 2017/746:

• Quality Management experts in developing internal procedures according to ISO 13485, such as post-market surveillance and vigilance, among many others.
• Regulatory Experts to guide, evaluate and prepare any regulatory document, including technical documentation and performance evaluations.
• Clinical Experts to support manufacturers in the design and monitoring of performance studies

Albert Negrete Hurtado, PhD, Regulatory Affairs Scientist at AKRN Scientific Consulting