By the end of 2021, the European Parliament adopted the proposal of the European Commission to amend the EU 2017/746 in vitro diagnostic medical device (IVD). This new position extends the IVDR transition timelines for manufacturers of certain IVDs, providing a progressive roll-out and aiming to avoid the disruption in the supply of IVDs to the European market.
Background and IVD regulatory landscape in Europe
The European IVD Regulation (IVDR 2017/746) will become fully applicable from May 26, 2022, thus repealing the previous directive (98/79/EC). Such replacement strengthens the regulatory framework by which IVDs are placed in the market, including their risk classification. Under this new regulation, approximately 80% of IVDs are expected to require the assessment of notified bodies; it is important to note that this percentage ranged between 10 and 20% under the directive. However, the number of notified bodies designated under the IVDR remains pretty limited (6 so far). Moreover, the difficulties arising from the COVID-19 pandemic have contributed to the delay in the designation 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.
Softer transition timelines for IVDs
Consequently, the European Commission has drafted an amendment to the regulation to extend the number of devices eligible for a “soft” transition. 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 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.
Nevertheless, be aware that IVDR’s requirements for post-market surveillance, market surveillance, vigilance and registration of devices, and economic operators must be applied from May 26, 2022. You can see a brief checklist of how to bring IVDs into compliance with the IVDR here.
How can AKRN help IVD manufacturers?
- Quality Experts: development and implementation of processes in accordance with EN ISO 13485 to comply with IVDR requirements on post-market surveillance, vigilance, market surveillance, and communication with economic operators, among many others.
- Regulatory Experts: strategic guidance, evaluation and preparation of regulatory documentation, including technical documentation and performance evaluation documentation.
- Clinical Experts: support manufacturers in designing, executing and monitoring clinical performance studies according to EN ISO 20916.
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