WET Devices Legally Expanded in European Legislation

By Heather Crawford and Evangeline Loh

The European Commission (EC) will officially publish amending legislation (two Delegated Acts) to expand the devices defined as well-established technologies (WET). WET was never formally defined in the Medical Devices Regulation (Regulation (EU) 2017/745 MDR) though by inference are defined to be “sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors” (Article 18(3), Article 52(4), and Article 61(6)(b)). 

WET devices were also understood per MDCG 2020-6 to be simple devices, with stable designs, and recognized safety and clinical performance, as well as a long history on the market. In our clinical evaluation consulting (clinical evaluation plan and report compilations) assessed WET.

Categorization as WET facilitates compliance and eases conformity assessment and exemption from clinical investigation. 

Delegated regulation - C(2026)1798

Article 61(6) on clinical evaluation, exempted implantable and Class III devices, from clinical investigations if the devices were the WET devices (Article 61(6)(b)).

The original list of devices are now included as Article 61(6)(b)(a), and a new list has been added (Article 61(6)(b)(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 centralizers, diaphyseal obturators, radiography markers, fiber ligatures, tubal extraluminal ligation devices, trans palatal 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 embolization coils, embolization particles, cables, shunts and internal defibrillation paddles.”

Delegated regulation - C(2026)1809

Article 52(4) on conformity assessment lists devices, which as WET, may benefit from the exemption to the requirement for the assessment of technical documentation for each device. (Reminder this is searchable in EUDAMED  as a “device type”.) 

The original list of devices in Article 52(4) is now delineated as Article 52(4)(a) and the newly added Class IIb implantable devices, included as Article 52(4)(b). These devices are as follows: “cannulas, catheters, feeding tubes, suture pledgets, suture sleeves, suture buttons, gastrostomy buttons, bone wax, bone fillers, bone substitutes, stem centralizers, diaphyseal obturators, radiography markers, fiber ligatures, trans palatal distractors, nails, anchors, spinal posterior fixations, textile braids, dental implants, orthodontic devices, dental barriers, suspensory fixations and cinches.”

Concluding remarks

The two Delegated Regulations will modify MDR Article 61(6)(b) and Article 52(4) to add more WET devices. Manufacturers are advised to review these lists as part of their regulatory strategy and device development process. 

The EC is motivated to appropriately simplify the European legislation on medical devices. Formally and legally expanding the list of WET devices is a welcome step for industry as Emergo experts have often found the clinical evaluation requirements for legacy devices, as well as simple devices with a long history of use (WET), to be extraordinary. These amending pieces of legislation, along with proposed simplification of the MDR (and IVDR), are certainly steps in the right direction.