EU Commission Proposal to Amend the Medical Device and IVD Regulations

Document Overview

On 16 December 2025, the European Commission published a landmark proposal (COM(2025) 1023 final) to amend Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR). This proposal responds to widespread stakeholder concerns about the regulatory framework's complexity, unpredictability, and disproportionate burden—particularly on SMEs.

The proposal also amends Regulation (EU) 2022/123 regarding EMA support for expert panels and Regulation (EU) 2024/1689 (AI Act) regarding harmonisation legislation references.

Key Themes and Changes

1. Simplification and Proportionality

Person Responsible for Regulatory Compliance (PRRC)

  • Removes detailed qualification requirements

  • SMEs no longer required to have PRRC "permanently and continuously" available—only "available"

Certificate Validity

  • Removes the 5-year maximum validity period for certificates

  • Replaces recertification with periodic reviews proportionate to device risk class

  • Notified bodies may limit validity only in exceptional, justified cases

Clinical Evidence

  • Broadens the definition of "clinical data" to include studies published in scientific literature

  • More flexible conditions for demonstrating equivalence to other devices

  • Removes the requirement for a contract with the equivalent device's manufacturer

  • Expands use of non-clinical data (in silico, bench testing, computational modelling) for demonstrating safety and performance

  • Promotes "New Approach Methodologies" (NAMs) to reduce animal testing

Well-Established Technology Devices

  • Introduces a formal definition for devices with simple, stable design and long market history

  • These devices benefit from more proportionate requirements and exemptions

Repackaging/Relabelling

  • Removes notified body certificate requirements and prior notice obligations for relabelling/repackaging activities

Classification Rules

  • Some devices reclassified to lower risk classes (e.g., reusable surgical instruments, accessories to active implantables, certain software)

2. Reduction of Administrative Burden

Summary of Safety and Clinical Performance (SSCP)

  • Scope reduced to devices requiring systematic technical documentation assessment

  • Separate notified body validation no longer required (as SSCP is already part of submitted documentation)

Periodic Safety Update Reports (PSURs)

  • Reduced frequency: Class IIb/III—first year then every two years; Class IIa—only "when necessary"

  • Notified body review integrated into surveillance activities

Vigilance Reporting

  • Extended timeline: 30 days (from 15 days) for reporting serious incidents not involving death, serious health deterioration, or public health threats

Changes After Certification

  • Clearer categorisation of changes: those implementable without notification, without prior approval, or requiring approval

  • Introduces predetermined change control plans agreed between manufacturer and notified body

Performance Studies (IVDs)

  • Routine blood draw studies exempt from prior authorisation

  • Removes notification requirement for companion diagnostic studies using left-over specimens

3. Innovation and Availability

In-House Devices

  • More flexible conditions for manufacture and use within health institutions

  • Permits transfer of in-house devices between health institutions where justified for patient safety or public health

  • For IVDs: removes the condition requiring no equivalent device on the market

  • Extends exemption to laboratory-developed tests used exclusively for clinical trials

Breakthrough Devices and Orphan Devices

  • Introduces formal definitions and criteria

  • Creates priority review pathways with rolling review

  • Expert panel designation and advice available

  • Certificates may be issued with limited clinical data if benefit outweighs risk

  • Fee reductions mandated for orphan devices

Derogations for Emergencies

  • Commission may authorise devices during public health emergencies without full conformity assessment

  • Competent authorities may grant exemptions during serious cross-border health threats, disasters, or crises

Regulatory Sandboxes

  • Member States and Commission may establish sandboxes for emerging technologies

  • Allows temporary waiver of certain requirements under strict oversight

Single-Use Devices/Reprocessing

  • Manufacturers must justify single-use designation

  • Devices not intended for single-use can be reprocessed per manufacturer instructions

  • Full refurbishing of single-use devices creates a new manufacturer relationship

  • Applies five years after entry into force

Orphan Device "Grandfathering"

  • Legacy devices meeting orphan criteria may continue on market beyond transitional periods (subject to conditions)

4. Predictability and Cost-Efficiency of Certification

Structured Dialogue

  • Legal basis established for documented pre- and post-submission dialogue between manufacturers and notified bodies

Conformity Assessment Procedures

  • Reduced notified body involvement for Class IIa, IIb, and Class B, C devices

  • Technical documentation assessment only for one representative device per generic device group/category

  • No systematic technical documentation assessment during surveillance

  • Class A sterile IVDs: no longer require notified body involvement

  • Remote audits permitted in place of on-site audits

  • Surveillance audits every two years (where justified)

  • Unannounced audits conducted "for cause" only

Clinical Evaluation Consultation Procedure (CECP)

  • Scope limited to Class III implantable devices only

  • Commission may add device types by delegated act

Performance Evaluation Consultation Procedure (IVDR)

  • Removed entirely

  • Replaced with early advice from expert panels for Class C and D IVDs

Notified Body Fees

  • Mandated fee reductions: at least 50% for micro enterprises; at least 25% for small enterprises; at least 50% for orphan devices

  • Commission empowered to set fee levels and structures

5. Governance and Coordination

Regulatory Status and Classification

  • Codifies the "Helsinki procedure" for coordination among competent authorities

  • Expert panel opinions available for borderline/classification disputes

  • Clear dispute resolution mechanism between manufacturers and notified bodies

Notified Body Oversight

  • Streamlined designation process with joint assessment teams (national authority + Commission + other Member State experts)

  • Joint assessment teams involved in monitoring at least every two years

  • Removes full reassessment requirement every five years

  • Authority responsible for notified bodies acts as "ombudsperson" in disputes

Expert Panels

  • Expanded scope and composition

  • May provide scientific, clinical, technical, and regulatory advice

  • EMA continues as secretariat

EMA Support

  • New mandate for EMA to support coordination among national competent authorities

  • Areas include: borderline/classification, multi-country clinical studies, derogations, vigilance, and market surveillance

  • SME support scheme to be established

6. Further Digitalisation

Compliance Tools

  • EU declaration of conformity may be digital

  • Label information may be provided digitally (subject to implementing rules)

  • Electronic instructions for use permitted for near-patient tests

  • All submissions under MDR/IVDR to be electronic

  • Economic operators must provide digital contact in Eudamed

Conformity Assessment

  • Technical documentation, reports, and other documents may be in digital format (machine-readable with version control)

Online Sales

  • Essential device information and instructions for use must be provided

UDI and Eudamed

  • Clarified provisions; some electronic systems may operate outside Eudamed if interoperable

7. International Cooperation

  • Promotes global regulatory convergence (IMDRF, MDSAP)

  • Commission may sign administrative arrangements with third countries

  • Reliance mechanisms may recognise assessments/inspections by foreign regulators

8. Interplay with Other EU Legislation

Combined Studies

  • Single application for studies involving medicinal products + devices + IVDs

  • Coordinated assessment under Clinical Trials Regulation

Cybersecurity

  • Serious incidents qualifying as actively exploited vulnerabilities must be reported to CSIRTs and ENISA through Eudamed

  • Manufacturers must also report vulnerabilities/incidents not qualifying as serious incidents

AI Act

  • MDR and IVDR moved from Section A to Section B of Annex I to Regulation (EU) 2024/1689

  • Limits AI Act application to devices to specific provisions

Why This Matters for Manufacturers

Immediate Benefits

  1. Reduced Costs and Administrative Burden

    • Fewer documentation requirements

    • Less frequent PSURs

    • Streamlined certification renewals

    • Digital submission options

  2. Greater Predictability

    • Structured dialogue framework

    • Clearer change control pathways

    • Dispute resolution mechanisms

    • Fee transparency and caps

  3. Faster Market Access

    • Reduced notified body involvement for lower-risk devices

    • Priority pathways for breakthrough/orphan devices

    • Rolling review capability

    • Regulatory sandbox opportunities

  4. SME-Specific Support

    • Mandated fee reductions (25-50%)

    • Relaxed PRRC requirements

    • EMA support scheme

    • Deferred payment options

Strategic Considerations

  1. Clinical Evidence Flexibility: The broadened definition of clinical data and enhanced use of non-clinical evidence may provide additional pathways for demonstrating safety and performance.

  2. Consultation Timelines: Reduced timelines for medicinal product and SoHO authority consultations should accelerate conformity assessment for devices incorporating such substances.

  3. Orphan Device Provisions: Manufacturers serving small patient populations should evaluate the orphan device pathway and associated fee reductions.

  4. Well-Established Technology: Understanding this new definition helps position products appropriately within the regulatory framework.

  5. Digital Documentation: Transitioning to digital technical documentation formats now will position manufacturers for streamlined future submissions.

Timeline Considerations

  • Entry into force: 20 days after Official Journal publication

  • General application: 6 months after entry into force

  • Notified body provisions: 12 months after entry into force

  • Cybersecurity reporting: 3 years after entry into force

  • Single-use device/reprocessing rules: 5 years after entry into force

Recommended Actions for Manufacturers

  1. Monitor legislative progress through the ordinary legislative procedure (Parliament and Council)

  2. Assess current technical documentation against new digital format provisions

  3. Review clinical evaluation strategies in light of expanded non-clinical data acceptance

  4. Evaluate orphan/breakthrough designation potential for applicable devices

  5. Engage with notified bodies to understand their implementation timeline and approach

  6. Review fee structures and explore SME support options where applicable

Conclusion

This proposal represents the most significant revision to the EU medical device regulatory framework since the MDR and IVDR entered into force. While maintaining the core objective of ensuring patient safety, the amendments address many of the structural issues that have hampered implementation. The proposal now enters the ordinary legislative procedure, with adoption anticipated around Q2 2027.

Manufacturers should begin preparing for these changes now, while also engaging with industry associations and regulators to provide input during the legislative process.

Source: COM(2025) 1023 final — Proposal for a Regulation of the European Parliament and of the Council amending Regulations (EU) 2017/745 and (EU) 2017/746

Jonathan PhillipsComment