A coalition of six European healthcare and notified body organisations has issued a joint statement opposing two Commission Delegated Regulations adopted on 20 March 2026, C(2026) 1798 and C(2026) 1809, which extend exemptions for so-called well-established technology (WET) devices under the Medical Device Regulation (EU) 2017/745.
WET devices are relatively simple products with a common, stable design that has changed little over time, a well-known safety profile, recognised clinical performance and a long history of market use. The criteria for identifying them are set out in Medical Device Coordination Group guidance MDCG 2020-6. Sutures, staples, screws, plates and dental fillings are typical examples. Because their risks and benefits are already well understood, WET status allows for a lighter regulatory pathway.
The signatories include Team NB, the TÜV-Verband, IG-NB, the European Social Insurance Platform (ESIP), the Association of Mutual Benefit Societies (AIM) and the Standing Committee of European Doctors (CPME). Their objection centres on how the two acts define the products covered.
Under the regulations, listed Class IIb WET device types are exempt with immediate effect from the technical documentation assessment required by Article 52, while listed Class III types are exempt from the clinical investigation obligation under Article 61(6). The groups are intended to cover the kind of simple, long-established products described above.
The joint statement argues that the lists name generic product groups rather than individual products, with no reference to materials, technology, intended purpose or the European Medical Device Nomenclature (EMDN). The organisations warn that this could expose patients to greater risk where high-risk products receive lighter scrutiny, produce inconsistent interpretation among manufacturers, notified bodies and competent authorities, and trigger disputes that delay market access.
The signatories also point to products that fall within the listed groups yet carry a troubled safety record. They cite atrioseptostomy catheters used in newborn cardiac surgery, withdrawn by two manufacturers after serious incidents, some of them fatal. They flag bone substitute materials as too heterogeneous to list, noting that a porcine-derived bone substitute was classified as a health concern by the expert panel during an Article 54 consultation.
The coalition asks the Commission to list the specific products identified during its stakeholder consultation rather than broad groups. It concludes that the regulations cannot be supported in their current form and require substantial revision to ensure legal certainty, consistent interpretation and alignment with the objectives of Regulation (EU) 2017/745.