In January 2024, the European Commission published a proposal for a Regulation of the European Parliament and of the Council amending regulations (EU) 2017/745 and (EU) 2017/746. This article discuses individual aspects and the most important changes made.
Eudamed
Perhaps the most significant part of the EC’s new proposal is earlier mandatory use of several modules of Eudamed. The problem of Eudamed’s launch seems to lay in the complexity of the database. There are 6 modules of Eudamed:
actor registration,
unique device identification (UDI) and device registration
notified bodies and certificates,
clinical investigations and performance studies,
post-market surveillance and vigilance,
market surveillance.
The first module has been functional since 2020 and the second and third since 2021. Those three modules are now available for voluntary use. Modules 5) and 6) should be ready at the end of 2024. Module 4) is scheduled to be correctly in function in last months of 2026. Late launching of the module is the main issue. Under current provision, Eudamed can only become mandatory if all modules are correctly functioning. This significantly slows the process of transition for the modules, that could be already in mandatory use. However, the EC believes, that it is beneficial to speed up the process and takes actions in order to achieve it. Still, mandatory use of all six modules cannot be expected before Q4 2027, with additional transition periods ending no earlier than Q2 2029.
Using this proposal, EC aims to enable a gradual implementation of individual Eudamed modules once they have been audited and declared functional. Mandatory use of several modules could then start as early as Q4/2025.
Eudamed is essential element of the whole medical device system under MDR and IVDR regulation. The idea of transparency and traceability of MDs and IVDs, as a core principal of the system, can be best fulfilled through unified database. Eudamed is also eagerly anticipated by member states, hospitals and economic operators themselves and its delay causes unnecessary complications. It is a responsibility of EC to ensure that modules to be mandatory under this new proposal, are tested and correctly functioning. We believe that the gradual roll-out is a step in the right direction.
Postponed dates for legacy IVDs
Another area that this new regulation covers, is the extension of transition periods for manufactures of legacy IVDs. Those manufactures need to ensure that their IVDs continue to comply with the rules in force when they were placed on the market for the first time, that there are no significant changes in the design or intended purpose of the IVDs, that the devices do not present an unacceptable risk to the health or safety of patients, users or other persons, or to other aspects of the protection of public health. They also need to show effort to become compliant with IVDR. The last condition is presented in two specific requirements. No later than 26 May 2025, every manufacturer must put in place a quality management system compliant with the IVDR. For devices requiring an assessment by a notified body (NB), the manufacturer must submit an application to the NB to transfer the device to the IVD Regulation by 26 May 2025 (all IVDs certified under IVDD and class D IVDs), 2026 (class C IVDs) or 2027 (class B and A sterile IVDs). The manufacturer and the NB have to sign a written agreement to proceed with conformity assessment no later than 26 September 2025 (all IVDs certified under IVDD and class D IVDs), 2026 (class C IVDs) or 2027 (class B and A sterile IVDs). If these conditions are met, the transition periods, during which legacy IVDs can be made available, will then be extended until 31 December 2027 for all IVDs, that have been subject to IVDD certification as well as for Class D, until 31 December 2028 for Class C and 31 December 2029 for Class B and Class A sterile.
According to the European Commission (EC) the aim of this proposal is to secure the availability of medical devices for patients and healthcare professionals. Reality of IVD’s market shows, that it is not prepared for smooth transition to IVDR rules. It was not required for most IVD’s to go through certification process under IVDD, however the opposite is true under IVDR. This means that many manufactures need to go through process they never encountered before and it can be costly and time demanding. The capacity of NBs is also limited and this problem has to be tackled in order to prepare the whole market for new rules.
Mechanism of prior notice in case of disruption of supply of certain MDs and IVDs
Lastly, EC is proposing to introduce a mechanism of prior notice by manufacturers in case of disruption of supply of certain critically important MDs and IVDs. Therefore, where manufacturers for any reason anticipate the interruption of supply of MDs or IVDs and it is reasonably foreseeable that the interruption may result in serious harm or a risk of serious harm to patients or public health in one or more Member States, manufactures should newly inform Member state authority, distributors and healthcare institution six month in advance. This should give the abovementioned subjects, enough time to consider mitigating actions.
Author: Gabriela Charvátová