European Commission Proposal COM (2025)1023 – Transforming MedTech Regulation

Main Ideas of the Proposal COM (2025)1023

Simplification & Proportionality

Article Reference	Current Position	Proposed Amendment	Practical Impact
MDR Art. 15 (PRRC)	SMEs must have a Person Responsible for Regulatory Compliance (PRRC) permanently and continuously available, with strict qualification requirements.	SMEs only need PRRC available (not permanently employed), with simplified qualification criteria.	It reduces administrative burden and cost for small business.
MDR Art. 56 (Certificates)	Certificates are valid for maximum 5 years and renewal requires full re-certification.	Certificates issued without expiry date, subject to periodic review.	Streamlines certification, avoids repetitive renewals, reduces bottlenecks.
MDR Annex VIII Rule 11 (Software)	Wide-ranging classification often pushes medical software into higher risk classes (IIa/IIb/III).	Rule 11 amended to down-classify certain lower-risk software.	Simplified oversight for digital health tools, allowing NB resources for high-risk devices.
MDR Annex VIII (Reusable surgical instruments)	Notified Bodies are needed even if harmonized standards are applied.	Less involvement from Notified Bodies if harmonized standards are used	It simplifies conformity assessment which saves time and money.
MDR Art. 54 (CECP)	Clinical Evaluation Consultation Procedure (CECP) applies broadly to Class III and implantable devices.	CECP limited to Class III implants only.	It reduces NB workload and delay for the manufacturer.
IVDR Art. 48 (PECP)	Performance Evaluation Consultation Procedure (PECP) applies to certain IVDs.	PECP for IVDR is completely removed.	Fast-tracks IVD approvals, reduces duplication of reviews.
MDR/IVDR – SME Fees	No mandatory fee reductions for SMEs.	≥50% fee reduction for micro enterprises and ≥25% for small enterprises	Providing direct financial relief to small and medium-sized businesses to support innovation and help them enter the market.

Summary:

This reform reflects the Commission’s effort to make MDR/IVDR proportionate and SME friendly. It aims to make regulations easier and more affordable for small businesses. By reducing fees, simplifying requirements, and focusing oversight on higher risk areas, the changes facilitate to market entry for smaller companies and digital health innovators

Benefits:

• SMEs will get more flexibility with PRRC requirements and reduction in fees.
• Down classification of low risk software will free NB resources allowing more time and resources for high risk devices.
• There will be less NB involvement for reusable instruments when harmonised standards are applied
• Certificates without expiry will reduce the need for repetitive renewals saving time, money and resources for both regulators and manufacturer.

Challenges:

• There is a risk of inconsistent interpretation of simplified PRRC qualifications across Member States.
• SMEs may still face challenges with digital transition despite fee cuts, as digitalisation presents new type of costs and challenges, that fees reduction may not fully cover.
• Down classification which is aimed at reducing the burden for lower -risk software may still include some tools that could directly clinical outcomes, raising concerns about under regulation of certain software.
• A decrease in NB workload may create oversight gaps if not balanced with strong post market surveillance (PMS).

Things to Improve:

• EU must provide extensive guidance on PRRC qualifications to prevent confusion.
• There should be designed training for SMEs on compliance under simplified rules.
• It is important to ensure robust post market surveillance to balance the reduction in pre market scrutiny.

Reduction of Administrative Burden

Article Reference	Current Position	Proposed Amendment	Practical Impact
MDR Art. 32 / IVDR Art. 29 (SSCP/SSP)	Detailed SSCP/SSP required for Class III, implantable devices and higher-risk IVDs, with extensive NB validation.	Streamlined SSCP/SSP requirements, simplified templates, reduced duplication.	Less documentation burden, hence faster NB review, which will help in clearer information for patients and professionals.
MDR Art. 86 / IVDR Art. 81 (PSUR)	Annual PSURs with extensive NB involvement.	Simplified PSUR reporting, harmonised digital templates, reducing NB validation.	Reduces repetitive reporting, lowers administrative burden which will support faster regulatory processing.
MDR Art. 87(3) / IVDR Art. 82 (Vigilance)	Serious incidents and FSCA reported via fragmented national/EU channels.	Streamlined vigilance reporting via EUDAMED, harmonised formats.	Simplifies reporting, faster detection of safety signals, less admin overhead.
IVDR Art. 58 (Performance Studies)	Separate, complex authorisation procedures for IVD performance studies, often duplicating MDR clinical investigation rules.	Aligned and simplified authorisation process for IVD performance studies, harmonised with MDR.	Reduces duplication, faster study approvals, clearer requirements for manufacturers.
MDR Annex VII / IVDR Annex VII (NB Conformity Assessment)	NB conformity assessment procedures are complex, with overlapping checks and documentation requirements.	Streamlined NB assessment procedures, clearer timelines, reduced duplication of tasks.	Predictable, efficient NB reviews, lower administrative costs for manufacturers.

Summary:

This reform focuses on reducing duplication and speeding up regulatory processes. By simplifying SSCP/ SSP, simplified PSUR reporting, centralised vigilance via EUDAMED and harmonised performance study companies can save on compliance costs. The reforms also clarify NB conformity assessment timeline which will allow them to work more efficiently, providing faster information to patients and professionals.

Benefits:

• Streamlined SSCP/SSP and PSUR templates save time and costs.
• Centralised vigilance reporting via EUDAMED improves efficiency and safety.
• Harmonised performance study approvals reduce duplication. Streamlined templates for SSCP/SSP help reduce paperwork.
• Easier PSUR reporting cuts down on repetitive tasks and speeds up regulatory processes.
• Centralized vigilance reporting through EUDAMED boosts efficiency and safety detection.
• Standardized performance study approvals reduce duplication and speed up the process.
• Clearer timelines for NB reviews make them predictable and lower costs.

Challenges:

• Transition to new templates may initially confuse manufacturers.
• Delay in EUDAMED rollout could undermine centralisation goals.
• Reducing NB workload may risk oversight gaps if not managed properly.

Things to Improve:

• Provide phased implementation with training materials.
• Ensuring EUDAMED modules are fully functional before making their use mandatory.
• Maintain strong NB audit mechanisms to safeguard patient safety.

Innovation & Availability for Special Patient Groups

Article Reference	Current Position	Proposed Amendment	Practical Impact
MDR – New Article 52a, New IVDR Art. 48a (Breakthrough Pathway)	No dedicated pathway for breakthrough or highly innovative devices; all follow standard conformity assessment.	Introduction of a Breakthrough Device Pathway with priority review, rolling submissions, and expert panel support.	Accelerates access for life-saving innovations, reducing time-to-market for novel technologies.
MDR – New Article 50, Article 120 (14) (Orphan Devices)	No special status for devices serving very small patient populations.	Creation of Orphan Device Status for devices serving ≤12,000 patients/year, with grandfathering for legacy orphan devices.	Supports rare disease patients, ensuring continued availability of niche devices that might otherwise be withdrawn.
MDR/IVDR – Regulatory Sandboxes	No formal mechanism for controlled testing of emerging technologies.	Establishment of Regulatory Sandboxes under competent authorities for supervised real-world testing.	Encourages innovation by allowing safe experimentation with AI-driven and digital health solutions.
IVDR Art. 48 (PECP)	Performance Evaluation Consultation Procedure applies to certain IVDs, adding extra review layers.	PECP removed entirely.	Speeds up access to diagnostic tests, especially critical for rare conditions and urgent patient needs.

Summary:

This section supports new technologies and rare disease treatments. The Breakthrough Pathway helps get life-saving devices to people faster. Orphan Device Status keeps special products available for small groups of patients. Regulatory sandboxes allow safe testing with AI and digital health. Removing PECP speeds up the approval process for diagnostics. These actions support new ideas while making sure patients can access them, strengthening Europe’s role in medical technology development.

Benefits:

• The Breakthrough Pathway speeds up access to important life-saving devices.
• Orphan Device Status protects special products for patients with rare diseases.
• Sandboxes allow safe testing of AI and digital health tools.
• Removing PECP helps to approve diagnostic tests faster.

Challenges:

• There is a risk of unequal access if breakthrough designation criteria are unclear.
• Grandfathering of Orphan Device may create loopholes for outdated technologies.
• Sandboxes require strong oversight to prevent misuse.

Things to Improve:

• Defining clear criteria for breakthrough designation.
• Periodically review the approvals of orphan device.
• Establish clear exit strategies for sandbox to transition innovations into standard regulation.

Predictability & Cost Efficiency of Certification

Article Reference	Current Position	Proposed Amendment	Practical Impact
MDR Annex VII / IVDR Annex VII (NB Conformity Assessment)	NB conformity assessment procedures are complex, with overlapping checks and documentation requirements.	Streamlined NB assessment procedures with clearer timelines, harmonised templates, and reduced duplication.	Improves predictability of NB reviews, lowers administrative costs, and accelerates certification.
MDR Article 52 / IVDR Article 48 (Conformity Assessment Routes)	Multiple conformity assessment routes exist, often requiring extensive NB involvement even for lower-risk devices.	Simplified conformity assessment pathways, reducing NB involvement for lower-risk categories.	Enhances cost efficiency by focusing NB resources on high-risk devices, reducing fees for manufacturers.
MDR Article 54 (Clinical Evaluation Consultation Procedure – CECP)	CECP applies broadly to Class III and implantable devices.	CECP limited to Class III implants only.	Narrows scope, reduces NB workload and consultation fees, speeds up approvals.
MDR Article 56a (New – Certificates without Expiry)	Certificates expire after 5 years, requiring full re-certification.	Certificates issued without expiry date, subject to periodic review.	Provides long-term predictability, avoids costly re-certification cycles, reduces NB workload.
MDR Article 50 (New – NB Coordination & Efficiency)	NB oversight and coordination across Member States.	Formation of EU-level coordination mechanism for NB practices, timelines, and fee structures.	This ensures harmonised NB performance, predictable costs, and consistent certification outcomes across the EU.

Summary:

Certification reforms align practices across Notified Bodies (NB) and reduce uncertainty. Streamlined assessment procedures, easier conformity routes, and a narrower scope for CECP help cut costs and delays. Certification changes aim to make procedures more uniform and affordable. Simplified processes and certificates that don't expire provide stability, allowing manufacturers to plan with confidence.

Benefits:

• Streamlined NB procedures and EU level coordination reduce uncertainty.
• Certificates without expiry provide long term stability.
• Simplified conformity routes lower costs for SMEs.
• Streamlined procedures help avoid repetition and save time.
• Easier approval processes cut costs for low-risk devices.
• Certificates that do not expire offer long-term stability and predictability.
• EU-wide coordination ensures consistent practices and outcomes.

Challenges:

• Differences in NB capacity across Member States may still exist
• Certificates without expiry date may lead to complacency if reviews are not rigorous.
• Harmonisation may take time to implement across diverse NB practices.

Things to Improve:

• Introduce EU wide performance benchmarks for NB.
• Strengthen the periodic review mechanisms for certificates.
• Provide clear fee structures to ensure predictability for manufacturers.

Digitalisation

Article Reference	Current Position	Proposed Amendment	Practical Impact
MDR Art. 92 / IVDR Art. 87 (EUDAMED database)	EUDAMED rollout is partial, with shocked modules and limited mandatory use.	Full mandatory use of EUDAMED for all actors, with accelerated completion of remaining modules.	Centralised digital platform improves transparency, traceability, and efficiency of regulatory processes.
MDR Art. 29 / IVDR Art. 26 (UDI system)	Unique Device Identification (UDI) requirements exist but implementation differ across Member States.	Strengthened UDI integration into EUDAMED and mandatory electronic submission.	Improves device tracking and reduces administrative duplication.
MDR Art. 87 / IVDR Art. 82 (Market surveillance & vigilance reporting)	Adverse event and vigilance reporting often paper-based or fragmented across national systems.	Mandatory digital reporting via EUDAMED, harmonised formats across EU.	Streamlined vigilance, faster detection of safety signals, reduced manual burden.
MDR Art. 31 / IVDR Art. 28 (NB certificates)	Certificates issued in paper form, with limited digital accessibility.	Certificates to be digitally uploaded to EUDAMED by Notified Bodies.	Predictable access for regulators and manufacturers which reduces paperwork.
MDR/IVDR – Communication with Competent Authorities	Communication often via national portals or paper submissions.	Shift to digital-only communication channels coordinated through EUDAMED.	Simplifies interactions, ensures consistency across Member States.
MDR/IVDR – SME Support Tools	Guidance and support for SMEs largely paper-based or fragmented.	Introduction of digital SME support portals under EMA/MDCG.	Accessible guidance and reduced administrative effort for smaller firms.

Summary:

Digitalisation reforms modernize MDR/IVDR processes by mandating full EUDAMED use, strengthening UDI integration and requiring digital vigilance reporting. NB certificates will be uploaded electronically, and communication with authorities will shift to digital only channels. This improves transparency and efficiency, reducing paper-based tasks and ensuring consistent operations across the EU.

Benefits:

• Full rollout of EUDAMED improves transparency and traceability.
• Mandatory digital vigilance reporting accelerates safety signal detection.
• SME support portals make guidance more accessible.
• Digital only communication simplifies interactions with authorities.
• NB certificates uploaded electronically reduce paperwork

Challenges:

• SMEs may face technical blockades in adopting digital systems.
• Data security risks increase with centralised digital platforms.
• Uneven digital readiness across Member States could slow adoption.

Things to Improve:

• Provide subsidised digital training for SMEs.
• Strengthen cybersecurity protocols for EUDAMED.
• Ensure that systems across Member States can work together.

Cybersecurity & Artificial Intelligence

Article Reference	Current Position	Proposed Amendment	Practical Impact
MDR Annex I (General Safety & Performance Requirements – GSPR)	Cybersecurity requirements are implicit, referenced mainly through IEC 62304 and ISO 14971, but not consistently enforced.	Explicit cybersecurity obligations added to GSPR, requiring manufacturers to demonstrate secure design, vulnerability management, and update mechanisms.	Strengthens patient safety by ensuring devices are resilient against cyber threats and maintain secure lifecycle management.
MDR Art. 61 / IVDR Art. 56 (Clinical Evaluation & Performance Evaluation)	AI-enabled devices assessed under general MDR/IVDR rules, with overlap from the AI Act (Annex I, Section A).	MDR/IVDR devices moved to Section B of AI Act Annex I, reducing dual regulation burden.	Simplifies compliance for AI-driven devices, avoiding duplication and clarifying responsibilities.
MDR Annex VIII Rule 11 (Software Classification)	Broad classification often pushes medical software into higher risk classes, requiring extensive NB involvement.	Rule 11 amended to down-classify certain lower-risk software, including AI-based decision-support tools.	Proportional oversight: lower-risk AI tools face reduced NB scrutiny, freeing resources for high-risk AI applications.
MDR/IVDR – Post-Market Surveillance (Art. 83 / Art. 78)	PMS obligations exist but cybersecurity monitoring and AI performance drift are not explicitly covered.	PMS expanded to include cybersecurity incident reporting and AI performance monitoring.	Continuous oversight ensures AI models remain safe and effective, and cyber vulnerabilities are addressed quickly.
MDR/IVDR – Regulatory Sandboxes	No formal mechanism for testing emerging AI technologies.	Introduction of Regulatory Sandboxes for AI-enabled devices under competent authorities.	Encourages innovation by allowing safe experimentation with AI in real-world conditions under supervision.

Summary:

This reform addresses emerging risks and opportunities. It ensures devices are secure against cyber threats and aligns AI enabled devices with AI regulations. The measures encourage safe AI innovation while maintaining a balance between patient safety and regulatory flexibility.

Benefits:

• Clear cybersecurity obligations strengthen device resilience.
• Alignment AI with the AI Act reduces regulatory overlap.
• Expansion PMS ensures continuous monitoring of AI performance and cybersecurity incidents.
• AI sandboxes encourage safe innovation under supervision

Challenges:

• Manufacturers may struggle with new cybersecurity requirements.
• AI sandboxes need careful supervision to avoid unsafe experimentation.
• Down classification of AI tools might lead to underestimating potential risks.

Things to Improve:

• Provide EU level cybersecurity guidance and best practices.
• Develop clear criteria for participation in AI sandbox.
• Ensure proportional oversight without compromising safety.

International Cooperation

Article Reference	Current Position	Proposed Amendment	Practical Impact
MDR Art. 101 / IVDR Art. 96 (International collaboration)	Cooperation with non-EU regulators is limited, mostly informal exchanges and reliance on IMDRF guidance.	Strengthened formal cooperation mechanisms with IMDRF, WHO, and third-country regulators.	Improves global alignment, reduces duplication for manufacturers seeking multi-market approvals.
MDR Art. 106 / IVDR Art. 99 (MDCG tasks)	MDCG provides EU-level guidance but has limited mandate for international outreach.	Expanded MDCG role to coordinate EU positions in international fora and facilitate joint projects.	Ensures EU voice in shaping global standards, increases predictability for industry.
MDR Annex XIV (Clinical Evaluation)	Clinical evidence requirements vary across jurisdictions, leading to duplication of studies.	Proposal encourages mutual recognition of clinical data and alignment with IMDRF principles.	Reduces burden on manufacturers, faster access to global markets.
MDR/IVDR – Vigilance & PMS (Art. 87 / Art. 82)	Adverse event reporting is EU-specific, with limited sharing internationally.	Enhanced data-sharing agreements with global regulators for vigilance and PMS.	Improves patient safety through faster detection of global safety signals.
MDR/IVDR – Harmonised Standards	Reliance on EU harmonised standards, sometimes diverging from ISO/IEC.	Stronger integration of international standards (ISO/IEC) into MDR/IVDR framework.	Facilitates global compliance, reduces technical barriers for manufacturers.

Summary:

The reforms strengthen Europe’s global role by improving cooperation with international bodies. Enhanced sharing of vigilance data and the integration of ISO/IEC standards further harmonize global compliance. Cooperation with other regulators improves alignment and reduces duplication for manufacturers. This positions Europe as a leader in establishing international med-tech standards.

Benefits:

• Stronger collaboration with IMDRF and WHO reduces duplication.
• Mutual recognition of clinical data accelerates global approvals.
• Integration of ISO/IEC standards facilitates global compliance.

Challenges:

• Aligning different regulatory frameworks across jurisdictions is complex and time – consuming.
• There is a risk that international negotiation may slow down EU decision making due.
• Manufacturers may face uncertainty during standard harmonisation process.

Things to Improve:

• Implement pilot projects for mutual recognition before full rollout.
• Provide clear guidance for manufacturers on global alignment.
• Ensure EU maintains leadership in shaping international standards.

Combined Studies

Article Reference	Current Position	Proposed Amendment	Practical Impact
MDR Art. 62 / IVDR Art. 57 (Clinical & Performance Studies)	Clinical investigations (MDR) and performance studies (IVDR) are regulated separately, requiring distinct applications and approvals even when studies overlap.	Introduction of combined study applications where a single protocol covers both MDR and IVDR requirements.	Reduces duplication of submissions, saves time and resources for manufacturers conducting multi-purpose studies.
MDR Art. 70 / IVDR Art. 66 (Ethics & Competent Authority approvals)	Separate ethics and competent authority approvals needed for MDR and IVDR studies.	Joint approval process for combined studies which is coordinated across authorities.	It provides simplifies administration, initiating faster start of studies and less disintegration.
MDR Annex XV / IVDR Annex XIII (Study requirements)	Distinct documentation requirements for MDR and IVDR studies.	Harmonised documentation templates for combined studies.	Predictable and consistent requirements, reduces paperwork.
MDR/IVDR – PMS & PMCF/PMPF integration	Post-Market Clinical Follow-up (PMCF) and Post-Market Performance Follow-up (PMPF) are separate obligations.	Integrated PMS plans allowed when devices fall under both MDR and IVDR.	Efficient lifecycle management, avoids parallel reporting obligations.
MDR/IVDR – Data sharing	Study data often separated between MDR and IVDR submissions.	Shared data sources within EUDAMED for combined studies.	Improves transparency, facilitates regulator and NB access to evidence.

Summary:

This reform simplifies research by allowing joint study applications and shared documentation. It reduces duplication, saves time and resources, and encourages efficient management and consistent supervision. Integrated PMS plans and shared data within EUDAMED further streamline oversight.

Benefits:

• Joint MDR/IVDR study applications reduce duplication of submissions.
• Harmonised documentation templates simplify requirements for submissions.
• Integrated PMS plans streamline lifecycle management.
• Shared data in EUDAMED improve transparency and regulator access.

Challenges:

• Coordination between ethics committees and authorities may be challenging.
• Manufacturers might need to redesign study protocols to fit combined templates.
• Sharing Data across EUDAMED needs strong safeguards.
• There could be delays if authorities are not on the same page regarding joint approvals.

Things to Improve:

• Provide model combined study protocols for industry use.
• Train ethics committees on joint approval processes.
• Strengthen data protection measures in EUDAMED.

Conclusion

The Commission’s proposal COM(2025) focuses on simplifying regulations and supporting innovation across the med tech ecosystem. Fee reductions and PRRC flexibility reduce burdens on SMEs, innovation pathways such as sandboxes and orphan status encourage new technologies, and alignment of AI devices with the AI Act clarifies responsibilities. While legislative changes may evolve during scrutiny, the central objectives remain simplification, predictability, competitiveness, and patient safety. This approach strengthens Europe’s position as a global leader in med tech, ensuring safe and innovative devices reach patients.

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