Proposed Amendments to the MDR and IVDR Regulations

1. Background

On December 16, 2025, the European Commission published a proposal for a regulation of the European Parliament and of the Council aimed at fundamentally amending the regulatory framework applicable to medical devices and in vitro diagnostic medical devices.

This initiative, referenced as COM(2025)1023 final – 2025/0404 (COD), is titled: “Proposal for a Regulation of the European Parliament and of the Council amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the simplification and reduction of the regulatory burden applicable to medical devices and in vitro diagnostic medical devices .”

The text also provides for related amendments to Regulation (EU) 2022/123, concerning the enhanced role of the European Medicines Agency (EMA), as well as to Regulation (EU) 2024/1689 (AI Act), in order to ensure the consistency of the European regulatory framework.

This proposal follows a targeted assessment of the MDR and the IVDR conducted by the Commission in 2024–2025, which highlighted persistent structural challenges in the implementation of the regulations, particularly with regard to regulatory complexity, administrative burden, certification capacity, and the impact on innovation and the availability of devices.

The project therefore aims to maintain a high level of health protection while making the regulatory framework more proportionate, predictable, and efficient.

2. General Objectives of the Proposed Amendment

The proposal has five major strategic objectives:

1. Simplify and streamline the regulatory framework without compromising safety requirements.

2. Reduce the administrative burden on manufacturers, notified bodies, and competent authorities.

3. Improve the predictability and cost-effectiveness of certification procedures.

4. Promote innovation, particularly for breakthrough therapies, orphan drugs, or treatments intended for limited populations.

5. Strengthen coordination and harmonization at the Union level, while maintaining a decentralized system.

3. Major Areas of Change to the Regulations

3.1. Simplification and Proportionality of Requirements

The project introduces an approach that is more based on actual risk:

• Elimination of detailed qualification requirements for the Person Responsible for Regulatory Compliance (PRRC) and relaxation of requirements for SMEs.

• Introduction of the concept of “well-established technology,” allowing for less stringent requirements for mature and historically safe technologies.

• Relaxation of clinical evidence requirements, with greater recognition of non-clinical data, post-marketing data, and alternative methods.

These measures are intended to address what is considered to be the overly prescriptive nature of the original regulations.

3.2. Reduction of the administrative burden

Several requirements have been simplified or streamlined:

• Reduction in the scope of devices subject to a Safety and Clinical Performance Summary (SCPS).

• Reduction in the frequency of updates to periodic safety update reports (PSURs) based on risk class.

• Extension of the reporting deadlines for certain serious incidents that do not pose an immediate risk to public health.

• Elimination of certain requirements for repackaging and relabeling.

The goal is to eliminate redundancies and low-value-added security requirements

3.3. Support for Innovation and the Availability of Devices

The text introduces new mechanisms:

• Specific and prioritized procedures for “breakthrough devices” and orphan devices.

• Establishment of “regulatory sandboxes” to test emerging technologies.

• Relaxation of the regulations governing devices manufactured in-house by healthcare facilities.

• Exceptions may be granted in the event of a public health emergency, including at the Commission’s initiative.

These provisions are intended to ensure that patients have access to innovative or critical medical devices, including in exceptional circumstances

3.4. Predictability and Effectiveness of Certification

The bill radically reforms the role of notified bodies:

• Elimination of the maximum validity period for certificates, replaced by proportionate periodic reviews.

• Reduction in the scope of technical documentation reviews for intermediate-class devices.

• Remote audits are permitted, and unannounced audits are limited to justified situations.

• Regulation of fees charged by notified bodies, with mandatory reductions for micro-enterprises and SMEs.

These measures are intended to restore economic operators’ confidence in the certification system

3.5. Strengthening European Coordination and Governance

The project strengthens governance without undermining the decentralized model:

• Codification of the coordination procedure for the qualification and classification of devices (“Helsinki procedure”).

• An expanded role for expert panels, with a broader scope of activity.

• Increased support from the European Medicines Agency (EMA) for coordination among competent authorities, managing shortages, and supporting small and medium-sized enterprises.

• Streamlining the designation and oversight of notified bodies through joint assessment teams.

The goal is a more uniform and consistent application of the Regulations throughout the Union.

4. Overall Assessment

This proposed amendment marks a significant shift—not in its fundamental objectives, but in the way it is implemented. It reflects a change in approach: from a framework perceived as excessively rigid to a system that is more pragmatic, proportionate, and focused on managing actual risk.

If adopted, this bill could:

• to improve the availability of medical devices in a sustainable manner,

• reduce compliance costs, estimated at more than 3 billion euros per year,

• enhance the attractiveness of the European market while maintaining a high level of patient protection.

🔗 Official source: https://health.ec.europa.eu/publications/proposal-regulation-simplify-rules-medical-and-vitro-diagnostic-devices_en