European Commission WET Technology Amendment: What Does it Mean for Clinical Evaluations in 2026?
The European Commission just expanded the list of devices under Article 61(6)(b) of the MDR.
Why it Matters
Well-established technology (WET) devices are low-risk, traditional, simple devices with common and stable designs. Their designs have little evolution, and the devices have well-known safety and clinical performance characteristics. WET devices also have a long market history and long-standing safety records.
Under Articles 61(6)(b) and 61(8) of the EU MDR, these devices only required a simplified regulatory pathway—perhaps most notably, an exemption from mandatory pre-market clinical investigations, provided that manufacturers still comply with clinical evaluation requirements and required common specifications. Previously, Articles 61(6)b and 61(8) listed devices such as “ sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips, and connectors” in the list of example WET devices. However, as of this week, the European Commission released as statement expanding this existing list.
The Expanded WET Device List
According to this week’s amendment released by the European Commission:
“In Article 61(6) of Regulation (EU) 2017/745, point (b) is replaced by the following:
‘(b) for which the clinical evaluation is based on sufficient clinical data and is in compliance with the relevant product-specific CS, where such a CS is available and that are one of the following:
(a) sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips, connectors,
(b) cranial perforators, cranio-blades, catheter passers, patties and strips, magnets for implantable pulse generators, port plugs, stylets and stylet guides, needles, needle holders, forceps, cannulas, atrioseptostomy balloon catheters, catheters coated with anticoagulants, blood bags incorporating anticoagulants, port catheters, introducers, dilators, ventricular drains, feeding tubes, suture pledgets, suture sleeves, suture buttons, gastrostomy buttons, bone tacks, bone wax, bone fillers, bone substitutes, stem centralisers, diaphyseal obturators, radiography markers, fiber ligatures, tubal extraluminal ligation devices, transpalatal distractors, nails, anchors, spinal posterior fixations, textile braids, dental implants, orthodontic devices, dental barriers, dental veneers, suspensory fixations and cinches, reusable surgical instruments, springs for skull enlargement, guidewires, pressure wires, pacing wires and leads, snares, lead caps, fixation and connector tools, endovascular embolisation coils, embolisation particles, cables, shunts and internal defibrillation paddles.’. "
Exempt from Clinical Investigation vs. Exempt from Clinical Evaluation
Of most importance, exemption per WET designation only applies to conduct of new clinical trials for a specific device. While WET should always be considered as part of scoping for a clinical evaluation, even if the device is on the latest WET device list from the European commission, manufacturers must still document a full clinical evaluation per Article 61.
Interpretation of the New WET Amendment in Practice
While this amendment is only hot off the presses this week, we’re already thinking about how this can affect clinical evaluations. We plan to seriously consider devices on this list when deciding whether or not to institute new post-market clinical follow-up (PMCF) studies, especially considering the Commission’s amendment on description of PMCF documentation released last quarter (check out more of our thoughts on this from our post from earlier this week).
