EU Commission Proposes Targeted Simplification of Medical Device Regulation

EU MDR Simplification Proposal 2025

In December 2025, the European Commission published a proposal to amend the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), formally titled COM(2025)1023. The proposal represents the most significant attempt since MDR’s entry into force to address well-documented challenges relating to regulatory burden, certification delays, and device availability, while preserving the high level of patient safety established under the current framework. 

The proposal follows a targeted evaluation of MDR and IVDR, which concluded that while the Regulations have strengthened safety and transparency, they have also resulted in disproportionate compliance costs, inconsistent implementation across Member States, and reduced predictability in conformity assessment, particularly for small and medium-sized enterprises (SMEs). The Commission estimates that the combined effect of the proposed simplification measures could yield more than €3 billion per year in cost savings across the sector. 

Objectives of MDR and IVDR Reform

The overarching aim of the proposed amendments is to streamline regulatory processes without lowering safety or performance standards. The Commission has emphasised that this is not a deregulation exercise, but rather a recalibration toward a more proportionate, risk-based system. Key objectives include: 

• Improving predictability and efficiency of Notified Body conformity assessments.
• Reducing unnecessary administrative burden for manufacturers.
• Supporting innovation and the continued availability of established and niche devices.
• Enhancing coordination and consistency across the EU regulatory system.

Notified Body Timelines and Procedures

One of the most impactful elements of the proposal concerns the role and operation of Notified Bodies (NBs). In parallel with COM(2025)1023, the Commission has circulated a draft Implementing Regulation setting out uniform procedural requirements for NB activities. While this implementing act is not yet adopted, it provides insight into the Commission’s intended direction. 

Under the draft framework, maximum timelines would be introduced for key stages of conformity assessment, including: 

• Application review and contract signature (up to 30 days) 
• Quality Management System (QMS) audit activities (up to 120 days) 
• Technical documentation assessment (up to 90 days) 
• Final certification decision and issuance (up to 15 days) 

These timelines are intended to be contractually agreed, transparent, and monitored, addressing long-standing concerns regarding open-ended assessments and unpredictable delays. 

In addition, the proposal introduces a formal legal basis for structured dialogue between manufacturers and Notified Bodies, both before and after submission, with the aim of reducing misunderstandings, incomplete applications, and iterative review cycles. 

It should be noted that the industry group representing Notified Bodies have raised concerns that the introduction of binding maximum timelines may not fully reflect the operational realities of conformity assessment under MDR, particularly for complex and higher-risk devices, among other concerns.

MDR Audit Changes and Risk-Based Oversight

The Commission also proposes adjustments to audit practices under MDR. Surveillance audits would move toward a more explicitly risk-based model, with the possibility of longer intervals – potentially up to two years where justified by a manufacturer’s compliance history and device risk profile. Remote audits would be formally permitted as part of surveillance activities. 

Unannounced audits, which have been a significant source of operational disruption for manufacturers, would no longer be expected as a routine measure. Instead, they would be conducted on a “for-cause” basis only, for example in response to serious non-conformities, safety signals, or other specific risk indicators.

Proportional Evidence Requirements Under MDR

The proposal introduces several measures intended to better align regulatory requirements with device risk and technological maturity. These include: 

• Removal of the fixed five-year maximum validity period for MDR certificates, replacing it with ongoing, risk-based periodic review.
• Expanded acceptance of non-clinical and alternative evidence, including bench testing, pre-clinical data, and in silico methods.
• Introduction of a formal concept of “well-established technologies”, allowing for more proportionate clinical evidence expectations.
• Reduced scope of Summary of Safety and Clinical Performance (SSCP) requirements.

For test laboratories, these changes may increase the strategic importance of robust non-clinical testing, particularly where manufacturers seek to rely less heavily on new clinical investigations. 

Digital MDR Compliance and Regulatory Coordination

The proposal also advances further digitalisation of MDR compliance. Manufacturers would be permitted to provide EU Declarations of Conformity in digital form, submit regulatory information electronically, and, in future, provide certain labelling information digitally, subject to implementing rules. 

At a governance level, the role of expert panels is expanded, and coordination mechanisms for borderline classification and regulatory interpretation are strengthened. The European Medicines Agency (EMA) would continue to support expert panels and provide additional coordination assistance to national competent authorities.

MDR and IVDR Implementation Timeline

At the time of writing, COM(2025)1023 remains a legislative proposal and is subject to negotiation under the EU Ordinary Legislative Procedure, involving both the European Parliament and the Council. 

Based on comparable legislative timelines and external regulatory analysis, adoption could plausibly occur in 2027, though this remains uncertain and dependent on political priorities and amendment complexity. Once adopted, the Regulation would enter into force 20 days after publication in the Official Journal, with most provisions applying six months thereafter. Certain measures are expected to have longer, phased application periods of up to three or five years. 

The draft Implementing Regulation on Notified Body procedures is on a shorter trajectory, with consultation ongoing in early 2026. If adopted, elements of the new NB timeline and audit framework could begin to apply earlier than the main MDR amendments, potentially on a staged basis extending into 2027–2028.

Impact on Medical Device Manufacturers

While the proposal has been broadly welcomed by industry stakeholders, its final shape and timing remain uncertain. Amendments during the legislative process may alter scope, timelines, or application dates. Nonetheless, the direction of travel is clear: a more proportionate, predictable, and coordinated MDR system, with a renewed emphasis on risk-based oversight and efficient conformity assessment. 

For manufacturers and their testing partners, early awareness of these proposed changes can support strategic planning, particularly in areas such as non-clinical testing strategies, technical documentation preparation, and long-term certification planning. 

References

• https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=COM:2025:1023:FIN
• https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=intcom:Ares%282025%2911081575
• Team-NB Position Paper – ANNEX VII – COMMISSION IMPLEMENTING REGULATION DRAFT (2025): https://www.team-nb.org/wp-content/uploads/2025/12/Team-NB-PositionPaper-Annex-VII-V1-20251216.pdf

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