Industry stakeholders say the European Union’s Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) have created significant hurdles for manufacturers and threaten patient access to treatments. They are calling on European legislators to make significant changes to the regulations, as well as the Clinical Trials Regulation (CTR) to rectify the problems.
In December 2024, the European Commission (EC) opened a public consultation to get stakeholder feedback on the effectiveness of MDR and IVDR in a targeted evaluation. The Agency said the evaluation is meant to help it assess the regulations as the EU revisits its implementation after years of challenges and delays. By the time the consultation closed on 21 March 2025, the commission had received nearly 600 comments from a wide range of stakeholders.
Industry stakeholders are unified in their belief that MDR and IVDR require significant reforms to prevent product shortages in the EU. Device industry group Medtech Europe also pushed for significant reforms to both MDR and IVDR. “Today, there is broad consensus that the regulatory framework (In Vitro Diagnostic Medical Devices Regulation 2017/746/EU (IVDR) and Medical Devices Regulation 2017/745/EU (MDR)) is unpredictable, complex, slow, and costly thus hampering competitiveness and innovation,” said Medtech Europe. “The result is that medical technologies – both new innovative devices and devices already on the market which need to transition to IVDR and MDR – currently struggle to reach European patients and health systems. Policymakers and stakeholders need to act decisively now to address this situation,” the group added.
Medtech Europe called for a package of legislative reforms for MDR and IVDR by early 2026 at the latest. The group said the reforms are needed to ensure the regulatory system is efficient, innovation-friendly, and well-governed. In the meantime, it also called for immediate targeted measures to ensure medical devices are available in the EU and that the medtech industry is viable in the economic zone.
“The immediate targeted measures should reduce the initial assessment times and cost while also making them more predictable, make change control more efficient, establish a pathway for breakthrough innovation, and adapt certificate validity to follow the device lifetime,” said Medtech Europe.
The European Federation of Pharmaceutical Industries and Associations (EFPIA) said it wants targeted amendments to the regulations to create a proportionate and risk-based regulatory framework. “Both Regulations, while aiming to ensure availability of high-quality devices, have created regulatory complexity, increased administrative burdens and introduced misalignment with the Clinical Trials Regulation (CTR), resulting in delays in patient access to innovation,” said the group. “These challenges discourage investment in Europe and impact patient access to advanced therapies.”
Among its recommendations, it said lawmakers should establish a single, integrated accountability body to ensure harmonization in how the laws are interpreted, regulatory disputes are resolved and improve harmonization among notified bodies (NB).
“The accountable body will also ensure a closer coordination between the medicines pathway and Medical Devices (MDs) / Companion Diagnostics (CDx) pathways and establish a process for consolidated scientific and regulatory advice covering combined trials involving medicinal products, integrated device combination products (iDDC) and IVDs,” said the group.
EFPIA said European database on medical devices (EUDAMED) deployment should be accelerated to support coordinated assessments of trials and trial data, and there should be appropriate pathways for breakthrough innovations, orphan products, and more. The group called for improved coordination between MDR, IVDR, and CTR. More specifically, it asked for a more efficient “All-in-One” coordination process to centralize and integrate the product submission process, minimize regulatory fragmentation, and reduce duplication.
EFPIA also asked for significant revisions to IVDR and MDR that include removing requirements for authorization and notification of certain performance studies and requirements for performance study applications for CE-marked devices in the IVDR. The group asked for clarifications and reforms to the MDR, such as removing the option to have national provisions for clinical investigations. It said the provisions potentially conflict with the “All-in-One” approach.
EuropaBio, the biotechnology industry group, also asked the European Commission (EC) to create a more harmonized legislative framework that better integrates CTR with MDR and IVDR. The group said the reforms should be considered in reviewing CTR and the EU Biotech Act, which is under development. “The lack of a streamlined interaction between the CTR and the MDR/IVDR increases the regulatory burden on sponsors causing delays in conducting combined studies in the EU, posing significant barriers to sponsors in terms of workability and efficiency, ultimately impacting patients,” said EuropaBio. “Innovators also must deal with fragmented implementation across Member States, adding another layer of complexity and unpredictability to an already challenging regulatory landscape.”
EuropaBio noted that there currently is not a dedicated procedure for combined trials. Instead, sponsors must submit two applications to the Clinical Trials Information System (CTIS) for the medicinal product under CTR and a separate application for products under MDR and IVDR. The group noted that the review process does not run parallel in many member states, which adds burdens and delays.
To address the problem, the group is calling for significant reforms. “This will create a more predictable environment for sponsors by introducing a standardized and simplified regulatory framework while ensuring patient access to innovation and boost EU competitiveness,” said EuropaBio. “To both improve competitiveness and access to new treatments, it is essential to address the current inconsistency and over-complexity by fostering coherence across legislations, regulations and procedures at EU and Member States level.”
REFERENCE: Regulatory Focus (RF); 25 MAR 2025; Ferdous Al-Faruque