What is changing under Article 61(6)(b)?
The Article 61 amendment broadens the WET list beyond the devices already named in the Regulation (EU) 2017/745 on medical devices (MDR). According to the Commission text, the added technologies are devices that have shown themselves to be well established in practice: they have common, simple and stable designs, well-known safety profiles, well-known clinical performance characteristics, and little evolution in indications or state of the art.
The expanded list includes a wider range of device types such as cannulas, catheters, feeding tubes, bone wax, bone fillers, bone substitutes, dental implants, orthodontic devices, and other established implantable technologies.
For manufacturers, this means that more implantable and class III devices may rely on existing clinical data rather than requiring a new clinical investigation, provided the legal conditions are met.
Important clarification: no exemption from clinical evaluation
Even where a device falls within the expanded Article 61(6)(b) list, the manufacturer is not relieved of the obligation to plan, conduct, and document a clinical evaluation under the MDR. The Commission text expressly states that the clinical evaluation must still be based on sufficient clinical data and comply with relevant product-specific common specifications where available.
That distinction matters. The 2026 amendment reduces the need for new clinical investigations for certain WET devices, but it does not reduce the expectation for a robust, well-documented clinical evaluation strategy.
What is changing under Article 52(4)?
C(2026)1809 introduces a parallel simplification for certain class IIb implantable devices. The amended Article 52(4) keeps the general rule that technical documentation assessment applies for every class IIb implantable device, but it enlarges the list of exceptions. The newly added list includes devices such as cannulas, catheters, feeding tubes, bone wax, bone fillers, bone substitutes, stem centralisers, diaphyseal obturators, radiography markers, fiber ligatures, transpalatal distractors, nails, anchors, spinal posterior fixations, textile braids, dental implants, orthodontic devices, dental barriers, suspensory fixations, and cinches.
This means that, for those listed class IIb implantables, notified bodies will not be required to assess the technical documentation for every device individually in the same way as for other class IIb implantables. That can reduce regulatory burden, but only within the narrower Article 52 conformity-assessment context.
Why this matters for manufacturers
Taken together, the two delegated regulations signal a more proportionate MDR approach for well-established technologies. For some devices, manufacturers may benefit from both changes at once: an Article 61 relief from the obligation to perform a clinical investigation, and an Article 52 relief from per-device technical documentation assessment by the notified body. But the two exemptions are legally distinct and should not be conflated.
What should manufacturers do now?
Manufacturers should therefore assess their portfolios against both amended provisions:
- whether any implantable or class III devices now fall under the expanded Article 61(6)(b) list, and
- whether any class IIb implantable devices now fall under the expanded Article 52(4) list.
They should also reassess their clinical evidence strategy, confirm whether sufficient clinical data already exist, and ensure the rationale for relying on an exemption is scientifically and regulatorily robust. For class IIb implantables, they should also consider whether the Article 52 change affects notified body planning and technical documentation review strategy.
Our perspective
These two delegated regulations are a targeted attempt to make MDR implementation more proportionate for technologies with long-established safety and performance profiles. They may reduce unnecessary regulatory burden for certain legacy and standard-of-care devices. At the same time, they do not lower the overall expectation for evidence, justification, and regulatory control.
