EU SoHO Regulation & MDR 2026: Preparing For The Evolving Regulatory Framework For Substances Of Human Origin (SoHO)

How MDR Article 5(5), MDCG 2023-1, the SoHO Regulation, Quality Management Systems, Regulatory Governance, and Risk-Based Compliance Are Reshaping the Future of SoHO Activities in Europe

The European Directorate for the Quality of Medicines & HealthCare (EDQM) published a June 2026 Position Paper examining the interaction between the EU Medical Device Regulation (MDR) and the Substances of Human Origin (SoHO) Regulation (EU) 2024/1938.

The paper responds to the European Commission's proposed revision of the Medical Device Regulation, concluding that legislative amendments to the MDR are not necessary. Instead, EDQM recommends revising MDCG 2023-1 guidance to provide greater clarity on the application of Article 5(5) MDR before the SoHO Regulation becomes fully applicable in August 2027.

The objective is to ensure that health institutions involved in SoHO activities are not subjected to overlapping regulatory obligations, duplicate inspections, or unnecessary administrative burdens while continuing to maintain high standards of patient safety, quality, and traceability.

Why This Position Paper Matters

Health institutions across Europe increasingly rely on:

• In-house manufactured medical devices 
• Research Use Only (RUO) products 
• Repurposed CE-marked medical devices 

to support activities involving blood, tissues, cells, reproductive cells, human breast milk, intestinal microbiota preparations, and other Substances of Human Origin (SoHO).

Without clearer regulatory interpretation, organizations could face:

• Dual compliance under MDR and SoHO Regulation 
• Duplicate inspections by different competent authorities 
• Increased documentation requirements 
• Additional technical file obligations 
• Regulatory uncertainty 
• Product shortages 
• Higher operational costs 
• Delays in patient access 

A harmonized regulatory framework can improve compliance while reducing unnecessary administrative complexity.

Executive Overview

The EDQM Position Paper emphasizes regulatory clarification rather than legislative reform.

A future-ready compliance strategy should be:

• Risk-based 
• Patient-focused 
• Regulatory complaint 
• Quality-driven 
• Scientifically justified 
• Inspection ready 
• Well documented 
• Supported by regulatory intelligence 
• Governed through strong Quality Management Systems 
• Aligned with both MDR and the SoHO Regulation 

Organizations preparing today will be better positioned for the transition in August 2027.

Understanding the EDQM Position Paper

The paper examines how Article 5(5) of the Medical Device Regulation applies to health institutions that use:

• In-house medical devices 
• Research Use Only (RUO) products 
• Repurposed CE-marked medical devices 

within SoHO activities.

Rather than recommending amendments to the MDR, EDQM proposes revising MDCG 2023-1 to clarify when Article 5(5) should apply and when the SoHO Regulation should be considered the primary regulatory framework.

Key Issues Highlighted by EDQM

1. MDR Article 5(5)

The position paper examines whether health institutions using RUO products or repurposed CE-marked devices should automatically be considered manufacturers under MDR.

2. Overlapping Regulatory Frameworks

Without clarification, organizations could become subject to both:

• Medical Device Regulation (EU) 2017/745 
• SoHO Regulation (EU) 2024/1938 

leading to duplicate compliance obligations.

3. Market Availability

Manufacturers may withdraw niche medical devices or replace them as Research Use Only (RUO) products because of increasing MDR compliance burdens.

This could reduce the availability of specialized products used in SoHO activities.

4. Legal Interpretation

EDQM argues that assigning a medical purpose to an RUO product does not automatically make a health institution the manufacturer under MDR.

5. Existing SoHO Controls

The SoHO Regulation already includes comprehensive requirements covering:

• Quality Management 
• Validation 
• Supplier qualification 
• Vigilance 
• Traceability 
• Responsible Person oversight 
• Regulatory inspections 

Applying additional MDR obligations in these situations may be disproportionate.

Regulatory Comparison

Potential Regulatory Challenges

Why Regulatory Clarification Is Important

The EDQM paper emphasizes that regulatory clarity would:

• Improve legal certainty 
• Reduce unnecessary compliance burdens 
• Avoid duplicate inspections 
• Maintain patient access 
• Support innovation 
• Improve regulatory consistency 
• Strengthening quality oversight
• Preserve high safety standards 

Building a Future-Ready SoHO Compliance Strategy

Organizations should focus on:

• Understanding Article 5(5) 
• Monitoring MDCG updates 
• Preparing for SoHO implementation 
• Strengthening Quality Management Systems 
• Maintaining robust traceability
• Supplier qualification 
• Risk management 
• Regulatory intelligence 

Compliance Readiness Assessment

1. Regulatory Governance

Review:

• Applicable legislation 
• Organizational responsibilities
• Internal governance 
• Regulatory accountability 
• Compliance policies 

2. Quality Systems

Assess:

• Quality Management Systems 
• Validation procedures 
• Supplier qualification 
• SOPs 
• Continuous improvement 

3. Documentation

Review:

• Validation reports 
• Technical documentation 
• Traceability records 
• Inspection reports 
• Regulatory documentation 

4. Risk Management

Evaluation:

• Device utilization 
• Clinical risks 
• Regulatory risks 
• Operational impacts 
• Corrective actions 

5. Regulatory Intelligence

Monitor:

• MDR revisions 
• MDCG guidance 
• SoHO implementation guidance 
• EDQM publications 
• European Commission updates 

SoHO Readiness Assessment

Best Practices

1. Establish Strong Regulatory Governance

Clearly define responsibilities under MDR and the SoHO Regulation.

2. Strengthening Quality Systems

Maintain effective validation, supplier qualification, traceability, and vigilance processes.

3. Monitor Regulatory Developments

Continuous track updates from:

• EDQM 
• European Commission 
• MDCG 
• National Competent Authorities 

4. Promote Cross-Functional Collaboration

Include:

• Regulatory Affairs 
• Quality Assurance 
• Laboratory Management 
• Clinical Teams 
• Procurement 
• Legal 
• Risk Management 
• Executive Leadership 

5. Conduct Gap Assessments

Evaluate current practices against future SoHO regulatory expectations well before August 2027.

Implementation Roadmap

Future Trends

Emerging developments include:

• Greater harmonization between MDR and SoHO Regulation 
• Updated MDCG guidance 
• Digital quality management systems 
• Enhanced traceability technologies 
• Increased regulatory intelligence 
• Risk-based inspections 
• Stronger governance models 
• Improved patient-centered regulation 

Business Benefits

Frequently Asked Questions

1. What is the purpose of the EDQM Position Paper?

It evaluates the interaction between MDR and the SoHO Regulation and recommends updating MDCG 2023-1 rather than amending the MDR itself.

2. Does EDQM recommend changing the MDR?

No. The paper concludes that legislative changes are unnecessary and instead recommends clarifying guidance.

3. Why is Article 5(5) important?

Article 5(5) defines when health institutions manufacturing or modifying medical devices in-house may fall under specific MDR obligations.

4. What concerns does EDQM highlight?

The possibility of duplicate inspections, overlapping regulatory frameworks, increased documentation, and reduced availability of specialized SoHO devices.

5. When will the SoHO Regulation apply?

The SoHO Regulation (EU) 2024/1938 is expected to apply from August 2027.

6. How should organizations prepare?

• Review of MDR responsibilities 
• Strengthening Quality Management Systems 
• Conduct regulatory gap assessments 
• Improve documentation 
• Monitor MDCG revisions 
• Develop implementation strategies 

7. How can Maven Regulatory Solutions help?

Maven supports:

• MDR compliance 
• SoHO regulatory readiness 
• Regulatory gap assessments 
• Quality Management System implementation 
• Technical documentation 
• Regulatory intelligence 
• Risk assessments 
• Inspection readiness 
• Lifecycle compliance 
• Regulatory strategy consulting 

Conclusion

The EDQM June 2026 Position Paper provides an important opportunity to improve the regulatory framework for Substances of Human Origin (SoHO) by clarifying the interaction between the Medical Device Regulation and the SoHO Regulation. Revising MDCG 2023-1 can help reduce regulatory duplication, improve legal certainty, preserve patient access to essential therapies, and ensure proportionate oversight without compromising quality or safety.

Why Choose Maven Regulatory Solutions?

Maven Regulatory Solutions supports healthcare organizations, laboratories, tissue establishments, blood establishments, and medical device manufacturers through MDR compliance consulting, SoHO regulatory readiness, Quality Management System implementation, regulatory gap assessments, technical documentation, inspection readiness, lifecycle compliance, and ongoing regulatory intelligence. Our experts help organizations navigate evolving European regulations while maintaining operational excellence and regulatory compliance.