By Regulation (EU) 2022/112, the EU has amended the transition provisions for certain in-vitro diagnostic medical devices and postponed the date of application for „in-house devices” to 26 May 2028. Even though the main date of application remains on 26 May 2022, the new legal framework allows for longer transition periods for in-vitro diagnostic medical devices, which are already on the market:

• Certificates issued by Notified Bodies under Directive 98/79/EC will expire on 27 May 2025 at the latest. This means that devices, which are certified by a Notified Body according to Directive 98/79/EC, may be placed on the market until 26 May 2025.
• Legacy devices, which are covered prior to 26 May 2022 by a valid Declaration of Conformity according to Directive 98/79/EC and are placed on the market without involvement of a Notified Body can continue to be placed on the market until the following deadlines, depending on their classification:

1. 26 May 2025 for class D devices;
2. 26 May 2026 for class C devices;
3. 26 May 2027 for class B devices;
4. 26 May 2027 for sterile class A devices.

Additionally, deadlines for making available on the market and putting into service have been defined.

For the handling of changes of devices, which are placed on the market under Directive 98/79/EC, we expect a guidance document similar to MDCG 2020-3 (Guidance on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD or AIMDD)

The requirements of the IVDR regarding post-market surveillance, market surveillance, vigilance as well as the registration of economic operators and devices will apply to all in-vitro diagnostic medical devices from 26 May 2022.