Proposal for a Regulation of the European Parliament and of the Council amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards a gradual roll-out of Eudamed, information obligation in case of interruption of supply and the transitional provisions for certain in vitro diagnostic medical devices (COM(2024) 43 final)

Protection of human health or safety (TBT)

Medical devices and in vitro diagnostic medical devices

Link to ePing

11.040 - Medical equipment

Human health

Regulation (EU) 2017/745 on medical devices (MD Regulation) and Regulation (EU) 2017/746 on in vitro diagnostics medical devices (IVD Regulation) establish a new regulatory framework for medical devices and in vitro diagnostic medical devices. Their objectives are a high level of protection of health for patients and users and the smooth functioning of the internal market for these products.The MD Regulation has been applicable since 26 May 2021. It was notified to the WTO as notification G/TBT/N/EU/71. In March 2023, the European Parliament and the Council adopted a staggered extension of its transition period, ranging from 31 December 2027 for high risk devices to 31 December 2028 for medium and lower risk devices. It was notified to the WTO as notification G/TBT/N/EU/943The IVD Regulation has been applicable since 26 May 2022. It was notified to the WTO as notification G/TBT/N/EU/72. In January 2022, the European Parliament and the Council adopted a staggered extension of its transition period, ranging from 26 May 2025 for high risk in vitro diagnostics to 26 May 2027 for lower risk in vitro diagnostics. It was notified to the WTO as notification G/TBT/N/EU/845Despite considerable progress over the past years, the capacities of conformity assessment (‘notified’) bodies designated in accordance with the IVD Regulation remain insufficient and manufacturers are not sufficiently prepared to meet the strengthened requirements of the IVD Regulation on time. This is threatening the availability of in vitro diagnostics on the EU market.This proposal extends the current transition period laid down in Article 110 of the IVD Regulation, based on certain conditions. The conditions would ensure that only devices that are safe and for which manufacturers have already taken steps to transition to the MDR will benefit from the additional time. This would give manufacturers and notified bodies more time to conduct the conformity assessment procedures in accordance with the IVD Regulation, if those conditions are fulfilled. The draft measure proposes to keep the staggering of the transition periods depending on the risk class of the device and proposes their extension until 2027 for class D IVDs, until 2028 for class C IVDs and until 2029 for class B and class A sterile IVDs. The extension of the transition period is complemented by an extension of the validity of certificates issued under the previous Directive 98/79/EC for the devices benefiting from the extended transition period. Also the validity of certificates that have already expired since 26 May 2022 would be extended under certain conditions.The proposal also aims to allow a gradual roll-out of the electronic systems integrated in EUDAMED that are finalised (e.g. systems for the registration of economic operators, devices and certificates), instead of delaying the mandatory use of EUDAMED until the last of the six modules is completed. This way, the mandatory use of EUDAMED will be implemented stepwise and in a more timely manner.   In addition, the proposal aims to introduce an information mechanism for signalling interruption of supply of certain medical devices and IVDs, where the manufacturer has reasons to believe that the interruption may lead to serious harm or pose a risk of serious harm to patients or public health.  

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