WET List, Delegated Act and MDR 2.0: Why Manufacturers Now Need a Robust Strategy
On May 27, 2026, the PRO-LIANCE Learning Update Factory took place, focusing on the WET List and the Delegated Act of March 2026.
The central question addressed, one that currently concerns many manufacturers of implantable and Class III medical devices, was: What does the planned expansion of the so-called Well-Established Technologies list mean in practice for clinical evaluation and the obligation to conduct clinical investigations?
Delegated Act C(2026) 1798 was adopted by the European Commission on March 20, 2026. Its aim is to expand the list of implantable and Class III devices under Article 61(6)(b) MDR that may, under certain conditions, be exempt from the requirement to conduct clinical investigations.
However, it is important to note: Inclusion in the WET List does not mean that no clinical evaluation is required. Manufacturers must still plan, conduct, and document a clinical evaluation in accordance with Article 61 MDR for products on the list. The key factor remains whether sufficient clinical data are available and whether relevant Common Specifications are met.
More opportunities, but also more uncertainty
The expansion of the WET List can represent a significant relief for some manufacturers. It creates the possibility to build a regulatory sound argument against the necessity of conducting their own clinical investigation for certain well-established technologies.
At the same time, discussions during the Update Factory live session made it clear: the new list does not only provide clarity. Many terms are open to interpretation. Examples such as “reusable surgical instruments,” “connectors,” “wedges,” and other broadly defined product groups raise practical questions about how narrowly or broadly these categories should be interpreted.
A key takeaway from the discussion was therefore: the list alone does not replace a strategy. Manufacturers must be able to justify why their product truly falls within a specific WET category. and why it meets the criteria of a Well-Established Technology.
Strong Argumentation Becomes the Decisive Success Factor
The PRO-LIANCE Update Factory online session highlighted that the practical use of the WET List will strongly depend on the quality of regulatory and clinical argumentation. A simple classification based on product naming is generally not sufficient.
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Helpful elements may include:
- A thorough analysis of intended purpose and indications
- A comparison with established technologies and the state of the art
- A structured classification using product groups, GMDN or EMDN codes
- A clear presentation of the clinical data situation
- Early alignment with the Notified Body
Especially in borderline cases, success often depends not only on whether a product somehow fits the list, but on whether the argumentation is consistent, evidence-based, and understandable for the Notified Body.
MDR 2.0: The Next Source of Uncertainty
Additional complexity arises from the MDR 2.0 proposal. While the Delegated Act expands the WET List, current discussions around MDR 2.0 suggest a more fundamental definition of Well-Established Technology devices. During the Update Factory, it was critically discussed whether manufacturers should now invest heavily in list-based argumentation, or whether a more robust strategy would be to build a solid WET justification independent of specific list terms.
The recommendation from the discussion: do not focus solely on the list, but on the defensibility of the overall strategy. If the regulatory framework changes again, a well-documented WET argumentation will be far more valuable than a purely formal list classification.
What Manufacturers Should Do Now
- Manufacturers should not ignore the new WET List, but also should not treat it as a simple shortcut. A structured review is advisable:
- Could the product potentially fall under one of the listed WET categories?
- Is the classification scientifically and regulatorily robust?
- Are sufficient clinical data available?
- Is the current clinical evaluation strategy still appropriate?
- Should the PMS or PMCF strategy be adjusted?
- How is the Notified Body likely to respond to the argumentation?
- Particularly important: a potential WET classification should not be considered in isolation. It must align with the clinical evaluation, PMS/PMCF plan, state-of-the-art analysis, and the overall MDR strategy.
Conclusion
The expanded WET List offers opportunities, but it is not a self-runner. For some manufacturers, it may simplify the regulatory pathway. For others, it will trigger new borderline questions and discussions with Notified Bodies.
The key point remains: manufacturers need a clear, defensible strategy. Those who assess early whether and how their product fits within the WET framework can better leverage regulatory options and avoid unnecessary risk in clinical evaluation.
Categories: News, Clinical Evaluation, Regulatory Affairs
Tags: MDR, Medical Devices, WET
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