European Commission proposes amendments to medical device regulations

The European Commission has  proposed an amendment to the Medical Devices Regulation (MDR) and to the In Vitro Diagnostic Medical Devices Regulation (IVDR) in order to not only enhance safety and transparency but also giving more time to medical devices manufacturers to adapt to such regulations.

The new proposal issued on 23 January aims to ensure availability of the medical devices and protect patient care by introducing the following three key changes:

Extension of the transition periods

Since many manufacturers are not sufficiently prepared to comply with the requirements of the IVDR for various causes and the capacity of notified bodies within the EU is limited, the proposal introduces extended deadlines for manufacturers and notified bodies to comply with the IVDR by giving them more time to complete, under certain conditions, the necessary conformity assessment procedures without lowering the requirements.

High-risk devices (that is, class D devices according to the IVDR) have until December 2027, devices with high individual and moderate public health risk (IVDR class C devices) until December 2028, and lower-risk devices (class B and A sterile devices) until December 2029. This should mitigate the shortage of IVDR at least in a short-term period.

Accelerated EUDAMED implementation

The European Database on Medical Devices (EUDAMED) will contain information about all medical devices and IVDRs placed on the EU market and consists of six modules: agency registration; Unique Device Identification and product registration; bodies and certificates; clinical investigations and performance studies; post-market surveillance and vigilance; and market surveillance.

The first three modules are currently available on a voluntary basis, while the post-marketing surveillance and vigilance and market surveillance modules are expected to be completed in 2024. The clinical investigations and performance studies module is not expected to be completed until the third quarter of 2026.

The Commission has proposed a phased roll-out of EUDAMED to facilitate effective implementation of the MDR and IVDR and intends to make its use mandatory once the modules have been audited and declared functional.

The Commission sustains that such measure is crucial for ensuring the availability of in vitro diagnostics, enhancing transparency in the medical devices sector and supporting patient care without imposing unnecessary burdens on manufacturers.

Mandatory prior notice for supply interruptions

At least six months in advance, manufacturers are required to notify competent authorities, distributors and healthcare providers, if they anticipate a disruption or discontinuation in the supply of in vitro diagnostics or medical devices. 

This measure is intended to give healthcare systems more time to foresee and implement a replacement solution or mitigating measures to ensure patient safety.

MedTech Europe's reaction

MedTech Europe in a statement reacted positively to the Commission's proposal. The industry trade association emphasised the importance of extending the IVDR transitional periods and the anticipated mandatory use of EUDAMED modules, as well as the obligation imposed to devices manufactures to notify in advance the discontinuation of a given device.

MedTech highlights that the extra time should be used efficiently in order to identify, address and solve existing issues, making sure that manufacturers can adapt to the IVDR before the deadline and fulfil the subsequent requirements.

According to MedTech, the mandatory EUDAMED implementation should meet some specific conditions, in particular administrative simplicity and no extra financial burdens for the manufacturers. The association stated: "The proposed amendments should avoid creating additional financial implications for device manufacturers and should be accompanied by guidance to support the smooth implementation of the proposed amendments as soon as possible". 

MedTech advocates continued dialogue among stakeholders to find lasting solutions for improving efficiency, fostering innovation and enhancing governance, aiming to make the regulations work effectively for patients and European health systems.

Osborne Clarke comment

The extension of the transitional period will not solve structural problems related to the implementation of IVDR. However, as pointed out by MedTech, the extension will have a positive input for healthcare stakeholders, as well as a mandatory prior notice for supply interruptions and the use of EUDAMED for an efficient implementation of MDR and IVDR to monitor the market.

The EU has shown that it is crucial to know how to give time to healthcare stakeholders to adapt to the new regulations. Ultimately, it reinforces this complex regulatory framework and increases the legal certainty of the regulations once they are applicable.