Background

In early 2025, the Commission launched an initiative to expand the list of “well-established technologies” (WET). These are devices that have a long history on the market, stable and relatively simple designs, and well-understood safety and clinical performance profiles.

Devices that qualify as WET are exempt from the following requirements:

MDR Article 52(4) and Article 61(6)(b) currently identify the following as WET: sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips, and connectors.

Draft Delegated Acts

Below is more information on the two draft delegated acts.

MDR Article 52(4): Technical Documentation Assessment

The draft delegated act (document C(2026)1809) is available: HERE

It proposes to add the following to the list of devices exempted from the obligation to perform an assessment of the technical documentation for every device:

cannulas, catheters, feeding tubes, suture pledgets, suture sleeves, suture buttons, gastrostomy buttons, 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

MDR Article 61(6)(b): Clinical Investigations

The draft delegated act (document C(2026)1798) is available: HERE

It proposes to add the following to the list of devices exempted from the obligation to perform clinical investigations:

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.

What about implant cards?

MDR Article 18 requires that an implant card be provided for all devices, except those in the current WET list: sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors

As of today, there is no proposed change to this list.

The MDCG’s 1 December 2025 working group meeting minutes note the following:

“Regarding the identified WETs, the CAs [competent authorities] raised some concerns about clarity, scope and transparency for patients, particularly on implant card exemptions. The Commission acknowledged the need for clarity and predictability, stressing that the list reflects extensive input from CAs and stakeholders. Although emphasising the need for proportionality and reaffirming its commitment to patient safety, the Commission took note of the points raised by CAs and proposed to further discuss certain technical considerations, before finalising the delegated acts, in particular on implant cards. A follow up discussion will be organized.”