CD-P-TO Calls for Clarification on MDR Implications for the SoHO Sector
The European Committee on Organs, Tissues and Cells (CD-P-TO) has adopted a position paper titled “Medical Devices Regulation and its Implications for the Substances of Human Origin Sector”.
The paper was adopted on 23 June 2026 and examines the current situation from a substances of human origin (SoHO)perspective, following the European Commission proposal to revise Regulation (EU) 2017/745 on medical devices.
The document focuses on the MDR framework, the application of Article 5(5) MDR on in-house medical devices, and the interpretation provided in MDCG 2023-1.
Focus of the Position Paper
The CD-P-TO highlights two specific scenarios affecting SoHO entities:
research use only (RUO) products to which a health institution ascribes a medical intended purpose;
CE-marked medical devices whose intended purpose is institutionally changed by a health institution.
According to the paper, MDCG 2023-1 treats both scenarios as triggering Article 5(5) MDR. However, the CD-P-TO considers that this interpretation may go beyond what the legislative text expressly supports and may create practical difficulties for SoHO entities.
Concerns for SoHO Entities
The position paper states that SoHO entities often depend on highly specialised, low-volume medical devices, particularly for the processing and storage of substances of human origin.
The CD-P-TO notes that some essential devices are being withdrawn from the market or are no longer placed on the market as fully MDR-compliant devices. In some cases, products may be reintroduced as RUO products, shifting responsibility and risk to SoHO entities.
The paper also raises concerns regarding CE-marked devices used beyond their manufacturer-defined intended purpose where no suitable alternative device is available.
Interface Between MDR and the SoHO Regulation
The CD-P-TO stresses the importance of clarifying the interface between the MDR and Regulation (EU) 2024/1938 on substances of human origin, which entered into force on 7 August 2024 and will apply from 7 August 2027.
According to the position paper, without clarification before that date, SoHO entities may face two overlapping regulatory regimes, with separate competent authorities, inspection frameworks and documentation requirements.
The CD-P-TO argues that the SoHO Regulation already provides a comprehensive safety framework for SoHO activities, including quality management systems, supplier qualification, validation of materials and equipment, traceability, vigilance reporting, competent authority inspection and authorisation.
Proposal from the CD-P-TO
The CD-P-TO does not propose changes to the MDR text or to the European Commission’s amending proposal.
Instead, it invites the European Commission and competent authorities, through the MDCG, to consider revising MDCG 2023-1 to provide greater clarity on the two scenarios identified.
The paper suggests that revised guidance should distinguish between genuine in-house manufacture by a health institution and the use of commercially sourced RUO products or CE-marked devices used beyond their original intended purpose in the SoHO context.
The CD-P-TO also proposes that RUO products and institutionally repurposed CE-marked devices used in SoHO activities should be governed by the SoHO Regulation, with oversight consolidated under the designated SoHO competent authority.
Impact on Medical Device and IVD Manufacturers
For medical device manufacturers, the position paper highlights the ongoing challenges caused by the availability of specialised, low-volume devices used in SoHO activities.
Manufacturers should pay particular attention to:
the regulatory status of devices used in SoHO processes;
product availability and discontinuation risks;
intended purpose statements and CE-marking scope;
the distinction between RUO products and medical devices;
the impact of MDR compliance costs on niche device portfolios;
interactions with health institutions using devices in SoHO contexts.
Although the paper does not address the IVDR framework directly, its discussion may also be relevant for IVD manufacturers supplying products used in donor screening, testing or other SoHO-related activities, particularly where product availability and intended purpose limitations create operational challenges for SoHO entities.
For manufacturers and suppliers, the position paper reinforces the importance of clear intended purpose definitions, regulatory planning and communication with SoHO users to avoid uncertainty around device use, availability and compliance expectations.
