The European Commission has published a comprehensive proposal to amend the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR). The initiative responds to persistent implementation challenges since the Regulations entered into force, including regulatory bottlenecks, Notified Body capacity constraints, and risks to device availability across the EU.

According to the Commission’s explanatory materials, the overarching objectives of the proposal are to simplify regulatory requirements, reduce unnecessary administrative burden, improve predictability of conformity assessment, and strengthen the system’s resilience in public health emergencies, while maintaining a high level of patient safety.

This article summarizes the key proposed changes, structured around the main thematic areas identified by the Commission, and highlights their potential implications for manufacturers, Notified Bodies, and other economic operators.

• Lower regulatory friction, especially for low- and medium-risk devices
• More predictable and cost-efficient conformity assessment
• Greater flexibility in clinical evidence and post-market obligations
• Improved market continuity, particularly for legacy, orphan, and innovative devices

This article highlights the proposed changes that are most relevant for manufacturers and explains their potential business and compliance impact.

1. Simplification and Proportionality

A central pillar of the proposal is the introduction of more proportionate regulatory requirements.

Notable changes include:

• Person Responsible for Regulatory Compliance (PRRC): The proposal removes detailed qualification requirements and the obligation for SMEs relying on an external PRRC to ensure permanent and continuous availability, allowing more flexible arrangements.
• Certificate validity: The current five-year maximum validity period for certificates would be removed. Instead, Notified Bodies would conduct periodic reviews proportionate to device risk.
• Clinical and non-clinical evidence: A broader range of data would qualify as clinical evidence. The use of non-clinical data alone to demonstrate safety and performance would be expanded, and “New Approach Methodologies” such as in silico testing would be explicitly promoted.
• Well-established technologies: A new definition would enable reduced regulatory requirements for devices based on mature technologies.
• Repackaging and relabelling: The requirement for Notified Body certification and prior notification for these activities would be removed.
• Classification rules: Certain devices, including reusable surgical instruments, accessories to implantable devices, and some software, would be reclassified into lower risk classes where justified.

These changes aim to better align regulatory scrutiny with actual device risk.

2. Reduction of Administrative Burden

The proposal introduces several measures intended to streamline post-market and certification-related obligations:

• Summary of Safety and (Clinical) Performance (SS(C)P): The obligation would be limited to devices requiring Notified Body technical documentation assessment, eliminating separate validation steps.
• Periodic Safety Update Reports (PSURs): Update frequency would be reduced, and Notified Body review would be integrated into routine surveillance.
• Vigilance reporting: Manufacturers would have 30 days (instead of 15) to report serious incidents not linked to public health threats, death, or serious deterioration of health.
• Post-certification changes: Clearer differentiation between changes requiring notification, approval, or no prior action would be introduced, with the option for predefined change control plans.
• Performance studies (IVDR): Routine blood-draw studies would no longer require prior authorization, and notification requirements for certain companion diagnostic studies would be removed.

3. Innovation and Availability for Special Patient Groups

Several amendments are designed to improve access to devices in exceptional or innovative contexts:

• In-house devices: Conditions for manufacture and use within health institutions would be made more flexible, including allowing transfers where justified. Under the IVDR, the requirement that no equivalent device be available on the market would be removed.
• Supply interruption reporting: A central IT tool within, or interoperable with, EUDAMED would be established to manage reporting and information exchange.
• Breakthrough and orphan devices: New criteria and priority conformity assessment pathways, including rolling reviews and access to expert panel advice, would be introduced.
• Public health emergencies: The Commission and Competent Authorities would gain expanded powers to authorize derogations and emergency market access.
• Regulatory sandboxes: Member States and the Commission could establish sandboxes to support emerging technologies.
• Single-use device reprocessing: Manufacturers would have to justify a “single-use” designation; non-single-use devices could be reprocessed; the person fully refurbishing a single-use device would be considered the manufacturer; the provision would apply after five years.
• Legacy orphan devices: Certain orphan devices certified under previous Directives could remain on the market beyond transitional periods under defined conditions.

4. Predictability and Cost-Efficiency of Certification

To address capacity constraints and unpredictability in conformity assessment:

• Structured dialogue: A formal framework for pre- and post-submission dialogue between manufacturers and Notified Bodies would be introduced.
• Reduced Notified Body involvement: For certain lower- and medium-risk devices, assessment would focus on representative devices rather than entire portfolios. Class A sterile IVDs would no longer require Notified Body involvement.
• Audits: Remote audits would be explicitly permitted. Surveillance audits could be reduced in frequency where justified, and unannounced audits limited to “for-cause” situations.
• Expert panel procedures: The scope of mandatory consultations would be narrowed, while early scientific advice would be expanded.
• Notified Body fees: Fee reductions for micro and small enterprises and orphan devices would be introduced, with the Commission empowered to set fee structures.

5. Improved Coordination Within the Decentralized System

The proposal strengthens cooperation across the regulatory network:

• Helsinki procedure: Coordination on device classification and regulatory status would be codified, with formal access to expert panel opinions.
• Notified Body designation and monitoring: The designation and monitoring of notified bodies would be streamlined through the involvement of joint assessment teams; regular monitoring would be maintained; the five-year full reassessment would be discontinued; and fees would be set by the Commission.
• Dispute resolution: Competent Authorities would assume an ombudsperson-like role in disputes between manufacturers and Notified Bodies.
• Expert panels and laboratories: Their role would be expanded and clarified, with continued EMA secretariat support.
• Support for SMEs: EMA would provide additional scientific and administrative assistance.

6. Further Digitalization

Digital transformation is another key theme:

• EU declarations of conformity, technical documentation, reports, and submissions could be provided in digital form.
• Certain label information and electronic instructions for use would be permitted.
• Economic operators would be required to provide digital contact details in EUDAMED.
• UDI and EUDAMED provisions would be clarified, and interoperability with external systems enabled.
• Online sales would be subject to clearer information requirements.

7. International Cooperation

A new section would formally promote regulatory convergence and cooperation with international partners, including frameworks such as the International Medical Device Regulators Forum (IMDRF) and the Medical Device Single Audit Program (MDSAP).

8. Alignment With Other EU Legislation

The proposal also clarifies interactions with other EU laws:

• Combined studies involving medicinal products and devices would be subject to coordinated assessment.
• Cybersecurity incidents and vulnerabilities would be aligned with the EU cybersecurity framework and reported to relevant authorities.
• According to the proposal, the MDR and the IVDR would be moved from Section A to Section B within Annex I of the EU Artificial Intelligence Act, indicating that, for AI systems used in medical devices, the application of the AI Act is expected to align more closely with the existing MDR/IVDR compliance and supervisory frameworks.

Conclusion

The proposed amendments signal a recalibration of the functioning and implementation of the EU medical devices regulatory framework. Their objective is to address the implementation frictions observed since the entry into application of the MDR and IVDR, while preserving the fundamental principles of safety and performance.

If the amendments are adopted largely in their proposed form, they are expected to improve regulatory predictability, potentially reduce compliance burdens—particularly for SMEs—and contribute to ensuring the continued availability of critical and innovative medical devices in the EU. The actual impact will ultimately be determined by the implementation and supervisory practices of the Competent Authorities and Notified Bodies.

📘Source:
https://health.ec.europa.eu/medical-devices-sector/new-regulations_en