EU Commission proposes major reforms to MDR

The European Commission has proposed targeted reforms aimed at simplifying rules for medical devices. The proposed reforms are part of a package of measures put forth by the Commission this week to advance the biotechnology sector, enhance access to cardiovascular treatments, and streamline medical device regulations.

On 16 December, the Commission proposed a measure to increase investments for biotech products to aid their advancement to market and a plan to address cardiovascular disease in the economic zone. Additionally, it proposed a new regulation to streamline the regulatory pathway for medical devices.

"Today's proposals will simplify EU rules for medical devices, support the digitalization of procedures, and offer a coherent framework so that companies can respond to changing market conditions and patient needs," said the Commission. "To speed up access to medical devices and guarantee a continuous supply, timelines to complete conformity assessments will be introduced.

"A stronger role for the European Medicines Agency (EMA) will strengthen coordination at EU level while companies will be offered more scientific, technical and regulatory expertise," it added. "The EMA will also monitor shortages of medical devices, and a list of critical devices will be created."

The proposed changes include removing detailed qualification requirements for the person responsible for regulatory compliance (PRRC) and easing the requirements for small- and medium-sized enterprises (SMEs) to have a PRRC in place continuously, removing the maximum 5-year period that certificates are valid, allowing more flexibility in the types of clinical data that are qualified, establishing a new standard for 'well-established technologies' that will be regulated more proportionately, and changing classification rules to reduce risk of certain devices.

The Commission noted that since the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) were adopted, their implementation deadlines have been repeatedly extended to prevent potential product shortages and allow more time for notified bodies and manufacturers to catch up. However, it said its proposed reforms are intended to address the underlying structural problems with the regulations.

"This proposal aims to streamline and future-proof the regulatory framework," said the Commission. "Its main objective is to simplify the applicable rules, reduce the administrative burden on manufacturers and enhance the predictability and cost-efficiency of the certification procedure by notified bodies, while preserving a high level of public health protection and patient safety, and thus to help achieve the initial objectives of the Regulations.

"This proposal is a response to requests from the European Parliament, several Member States, and numerous stakeholders for a simplification of the regulatory framework for medical devices and for measures to ensure the availability of devices," according to the Commission. "A new regulation is needed to remedy the problems that have been identified, which otherwise would have a considerable impact on the medical devices market and, consequently, on the quality of healthcare provided to patients in the EU."

Among the reforms, the Commission said the proposed changes will reduce administrative burdens and enhance coordination among regulatory actors by creating more efficient reporting requirements, simplifying regulatory rules, and streamlining regulatory procedures. It also said conformity assessments will be more proportionate and targeted, breakthrough technologies will receive additional support, it will provide more legal certainty and predictability to manufacturers, improve coordination on the EU level, and streamline oversight of notified bodies, and reinforce cooperation with international regulators.

Among the Commission's changes to reduce administrative burdens, it proposed narrowing the scope of summary of safety and (clinical) performance (SS(C)P) that need to be submitted to devices where the notified body must conduct a technical documentation assessment. It said notified bodies would no longer need to submit a separate validation for the devices.

Furthermore, the Commission proposed reducing the need to submit periodic safety update reports (PSURs) and stated that they would be integrated into their surveillance activities. Additionally, manufacturers would have 30 days to report certain serious incidents instead of 15 days, and notified bodies can agree on a predetermined change control plan (PCCP) with the manufacturer to allow specific changes to their product without prior notification.

As part of the reforms, the Commission proposed setting maximum timelines for notified bodies to complete their conformity assessments. It also floated reforms aimed at ensuring timely certification for breakthrough medical technologies (Related: EU Commission proposes new timelines for notified bodies, Regulatory Focus, 16 December 2025).

The lobby group Medtech Europe welcomed the proposed reforms while noting that they don't go far enough.

"The MDR and IVDR have each strengthened the EU regulatory system for medical technologies," said Medtech Europe. "At the same time, their structural deficiencies have led to serious unintended consequences, including certification bottlenecks, reduced availability of products for patients, and unsustainable pressure on (SMEs).

"Revising what is not working well, while preserving what already functions effectively, is therefore both necessary and timely," the group added.

While Medtech Europe said the streamlined governance structure proposed by the Commission is a good step, it argued that it missed the opportunity to create a single governance structure. It also praised the proposed regulatory simplifications, but again said they didn't go far enough.

"Many improvements are proposed to increase system efficiency, including extending the validity of certificates, making reporting more risk-based, simplifying the management of product changes, and enabling more digitalization," said Medtech Europe. "Yet, lack of early clarity on clinical evidence expectations leads to unpredictability, unnecessary rework, and delays in making devices available to patients."

All the legislative proposals will be submitted to the European Parliament and Council for review and adoption. The Commission stated that it will also collaborate with Member States to initiate the implementation of the proposed reforms.

EU Commission proposed reforms

Medtech Europe statement

EU Commission proposes major reforms to MDR

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