EU officials detail proposed MDR, IVDR revisions

BRUSSELS – Experts from the European Commission shed light on the proposed wide-ranging changes to the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) that have been put forth to the European Council and European Parliament for adoption. They say the changes are intended to address shortcomings in the legislation that have significantly delayed their full adoption over the past few years.

The European Commission's Olga Tkachenko, a policy officer, and Peter Bischoff Everding, a senior expert at the medical devices unit, outlined the Commission's proposed revisions to the MDR and IVDR during a presentation at the DIA-RAPS Combination Products in the EU conference. They noted that the overall objective of the proposals was to simplify the rules, reduce the administrative burden, make the regulatory system more predictable, lower costs, and speed up the process – all while not compromising patient safety or expectations for how medical devices are intended to perform.

The regulators said the revisions focus on eight broad objectives, including enhancing predictability and cost-effectiveness in the certification process. Tkachenko noted that to achieve the objective, the Commission proposed changes to the conformity assessment procedures, including developing pre- and post-submission structured dialogues between manufacturers and notified bodies based on documented procedures.

"This is an activity that is already taking place to some extent now, but it will have a proper legal basis in the proposal," she said.

Tkachenko said the Commission has proposed several revisions to its audit requirements to make them more risk-based and reduce routine activities, such as allowing remote audits to replace on-site audits, and allowing audits every two years instead of annual audits. The revisions also propose reducing fees for micro and small manufacturers and reducing notified body involvement for technical documentation for low- to medium-risk devices. Additionally, the proposal removes notified body involvement for class I IVDs.

"A high-cost element of conformity assessment is technical documentation assessment," said Tkachenko. "There are a number of proposals to simplify that, in particular for lower classes of devices, to have a smaller number of technical documentation files assessed routinely, but still to keep the possibility for the notified bodies to assess technical documentation when they see a concern or reason to do that."

To enhance predictability, Tkachenko also said that the Commission has proposed revisions to special procedures, such as reduced timelines for drug consultations and substance of human origin (SoHO) to about a maximum of 120 days from 210 days. It also proposed reducing the scope of companion diagnostics consultations to focus on the clinical performance of the companion diagnostic.

Making regulatory requirements more proportionate to their risk is another broad goal of the proposed revisions. Everding said that the Commission has proposed changes to its clinical evidence requirements. He noted that clinical evidence was a focus of MDR and IVDR, but in some areas, the requirements may have been "too far reaching."

"What we suggest is to make it easier for manufacturers to use available clinical data in order to demonstrate the performance of the devices for the MDR," said Everding.

The changes include updating the definition of clinical data, allowing ‘well-established technology devices’ to have lower clinical evidence requirements, allowing the use of clinical data from equivalent devices, and allowing non-clinical data to enhance the overall data. Manufacturers will also not be required to have a contract with the equivalent device manufacturer, and the equivalence characteristics requirements would also be changed so that similar materials in similar clinical conditions may be sufficient. Other changes include removing overlaps in vigilance data assessment requirements between national competent authorities and notified bodies, and removing overly prescriptive qualification requirements for the manufacturer's designated person responsible for regulatory compliance.

The Commission has proposed steps to reduce administrative burdens associated with the manufacturer's reporting requirements, such as allowing predetermined change control plans (PCCP). Everding noted that PCCPs are currently primarily used for software, but the Commission has not limited them to software products only.

The Commission has also proposed limiting the scope of Summary of Safety and (Clinical) Performance (SSCP, SSP) and removing notified body validation, reducing the frequency of updating Periodic Safety Update Reports (PSUR) and allow manufacturers more time to report serious incidents that are not related to public health threat, death or serious deterioration of health from 15 to 30 days. To support innovation and address special situations, the Commission has proposed several changes, including adapting conformity assessment procedures for breakthrough technologies and orphan devices, using regulatory sandboxes on the national and EU level, grandfathering legacy orphan devices, and allowing more flexibility for in-house devices.

"For combination products or combined studies, there [are] a number of simplifications proposed," said Tkachenko. "For example, there's a possibility to transfer devices between health institutions, which was not possible before, but with a justification... if it's in the interest of patient safety, then you can do it."

The Commission also proposed several changes to streamline regulatory procedures and improve governance by proposing coordinated oversight of notified bodies. The proposed changes include streamlining the designation process, allow fees from notified bodies to pay for national experts to help in joint assessments, allow joint assessment teams to monitor notified bodies, and allow national authorities to institute a resolution mechanism to address disputes between manufacturers and notified bodies.

“What we quite often heard is that there is no possibility for manufacturers to appeal against the notified body's decision or non-decision, or any act or activity,” said Everding. “We want to trust the national competent authorities or national authorities for notified bodies.”

The proposed changes also recognize that notified bodies act in the public interest and proposed changes to the notified bodies coordination mechanism and to streamline coordination between national competent authorities (NCAs) and expert panels.

The Commission proposed enhancing EMA's role in the regulatory process by making several changes to the management of expert panels, such as expanding early advice to manufacturers, and using expert panels more to advise the Commission and member states in their decision-making. It also proposed changes to provide scientific, technical, and administrative support for coordination among the NCAs.

The Commission emphasized the need to promote digitalization in their MDR and IVDR revisions, which include measures such as extending the possibility to use electronic instructions for use (e-IFU), allow digital labeling that is not critical for the safe and effective use of the product, enabling digitalization of conformity assessment procedures, documents, and reporting, and reinforcing online marketing requirements.

Finally, to promote international cooperation and reliance, the Commission said it would strengthen its relationship with the International Medical Device Regulators Forum (IMDRF) and Medical Device Single Audit Program (MDSAP) and consider the use of international reliance during the certification process.

Aligning legislations was another big goal of the Commission, which includes allowing single application processes for authorizing combined studies not just under MDR and IVDR but also in line with the Biotech Act and Clinical Trial Regulation (CTR). It also proposed a single regulatory framework for artificial intelligence (AI) medical devices.

While the Commission is considering adopting the changes by mid-March, Everding noted that the deadline has been pushed back in the past and likely will be pushed back again. Regardless, he and Tkachenko urged stakeholders to comment on the changes even though the opportunity to use public comment to update the legislations has passed.

"We won't change the proposal, we cannot change the proposal, but we will assess and summarize the feedback that is made available and inform the member states in the Council Working Party and the European Parliament,” said Everding.

2026 Combination Products in the EU

EU officials detail proposed MDR, IVDR revisions

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