On 28th of January 2022, the European Commission published in the Official Journal of the European Union an amending regulation as regarding to the transitional provisions of the in vitro diagnostic medical device (IVD) regulation for certain IVD medical devices. The extensions to the transition period applies to higher-risk devices that are already on the EU-market in May 2022 under the medical device directive.
After the original IVDR date of application (26th of May 2022), new IVD products shall be placed on the EU-markets in compliance with the IVD Regulation. However, for example, HIV and hepatitis tests that are already on the EU-market will have an extension of the transition period and may be placed on the market according to new transition period. The length of the extension depends on the IVDR-based risk classification of the product;
- Risk class D until 26.5.2025
- Risk class C until 26.5.2026
- Risk class B and A (sterile) until 26.5.2027
The purpose of the extension is to ensure that notified bodies and manufacturers are able to meet the requirements of the new legislation. It is worth noting that some of the requirements of the IVD Regulation (eg. post-market surveillance activities, distributor / importer requirements) will come into force for all IVD devices as originally scheduled.
To read more, please see Finnish National competent Authority Fimea webpages: https://www.fimea.fi/-/eu-komissio-julkaissut-muutosasetuksen-ivd-asetuksen-eu-2017/746-siirtymaaikojen-muutoksista
Link to Amending Regulation: https://eur-lex.europa.eu/eli/reg/2022/112/oj