On 20 March 2026, the European Commission adopted a Commission Delegated Regulation (C(2026) 1798 final) amending Regulation (EU) 2017/745 (MDR) regarding the list of implantable and Class III devices exempted from the obligation to perform clinical investigations under Article 61(6)(b).
Why this matters: The act builds on the MDR concept of well-established technologies (WET)—devices with common and stable designs, well-known safety and clinical performance, and a long history of use on the EU market (criteria referenced in MDCG guidance).
What changes: Based on experience with MDR implementation and stakeholder consultation through the MDCG, the Commission expands the list of device types in Article 61(6)(b) that may benefit from a simplified approach (i.e., exemption from conducting clinical investigations), provided: the clinical evaluation is based on sufficient clinical data, and it complies with relevant product-specific Common Specifications (CS), where available.
Important clarification: Even when exempt from clinical investigations, manufacturers remain required to plan, conduct and document a clinical evaluation in line with Article 61 MDR.
Entry into force: The Delegated Regulation enters into force on the 20th day after publication in the Official Journal of the European Union.
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