The MDR is evolving: Expansion of Devices Exempt from Clinical Investigations
📌 A Targeted Amendment to Regulation (EU) 2017/745
On March 20, 2026, the European Commission adopted Delegated Regulation (EU) C(2026) 1798, amending Regulation (EU) 2017/745 on medical devices (MDR).
This text is part of an ongoing series of adjustments to the MDR based on feedback received since its implementation. More specifically, it addresses the requirements for clinical evaluation, particularly those cases in which clinical investigations can be avoided.
The Commission’s objective is clear: to adapt the regulatory framework to better account for certain medical technologies whose safety and performance are already well established.
🎯 Broader recognition of “proven technologies”
The regulation is based on the concept of well-established technologies (WET), which was already introduced in the MDR and further clarified, in particular, by MDCG Guidance Document 2020-6. These are devices characterized by a stable design, well-established use, and a history of use without major safety issues.
Based on the experience gained in implementing the MDR, the Commission considers that more devices meet these criteria. The Delegated Regulation thus expands the list of implantable and Class III devices that may be eligible for an exemption from clinical investigation.
This development is the result of a broad consultation with stakeholders, including, in particular, the Medical Device Coordination Group (MDCG) and the competent authorities of the Member States.
🧩 A significant expansion of the list of affected devices
The amendment concerns Article 61, paragraph 6, subparagraph (b) of the MDR, the text of which is being replaced to cover a significantly larger number of devices.
In addition to the devices traditionally included (such as sutures, screws, plates, dental crowns, etc.), the new version now encompasses a wide variety of technologies. These include, in particular, cranial drills, implantable chambers, bone fillers, bone substitutes, dental implants, guide wires, embolization devices, and reusable surgical instruments.
⚠️ A regulated simplification: clinical evaluation remains mandatory
It should be noted, however, that this exemption does not mean that the clinical requirements have been eliminated. The regulation explicitly states that manufacturers remain required to plan, conduct, and document a clinical evaluation in accordance with Article 61 of the MDR.
In practice, only the requirement to conduct a clinical investigation is waived for the devices in question, provided that sufficient clinical data are available and that the assessment complies with the applicable requirements, including any common specifications.
🏭 What are the implications for manufacturers?
For manufacturers, this development represents a significant opportunity. In particular, it helps reduce the costs and time associated with clinical development, while facilitating market access for certain categories of devices.
However, this simplification comes with strict requirements regarding justification. Manufacturers will need to be able to rigorously demonstrate that their device is based on proven technology and that the available data is sufficient to support the clinical evaluation.
This is not a relaxation of the requirements per se, but rather an adjustment to the clinical demonstration procedures, aimed at maintaining a high level of safety while avoiding disproportionate burdens for technologies that are well established.
🔎 Conclusion
With this text, the European Commission reaffirms its commitment to aligning the MDR with industrial and clinical realities. The expansion of the list of devices exempt from clinical investigations represents a significant development that is expected to have a tangible impact on manufacturers’ regulatory strategies.
👉 Isocèle Conseil helps you ensure compliance with clinical evaluation requirements.
Read the full text here -> Delegated Regulation (EU) C(2026) 1798