in force 2026-07-19 MODIFIED+1,263 −139§
Amended by Regulation (EU) 2026/1359 32026R1359 · Regulation (EU) 2026/1451 32026R1451
applies from: unchanged
Point (b) of paragraph 6 no longer lists a single flat set of exempted device types, but instead restructures the list into two sub-lists, one repeating the original items such as sutures, staples, dental fillings and similar fasteners, and a second, newly added sub-list naming a much larger range of additional device types including items such as cranial perforators, catheters, guidewires, embolisation coils and various surgical instruments.
The condition that the clinical evaluation for these devices be based on sufficient clinical data and comply with the relevant product-specific common specification, where available, is retained but is now expressed as an introductory qualifier applying to both sub-lists rather than to a single list.
Cited: Art. 61, v2 · Art. 61, v1
text before / after
02017R0745-20260101 → 02017R0745-20260719
Article 61
Clinical evaluation
1. Confirmation of conformity with relevant general safety and performance requirements set out in Annex I under the normal conditions of the intended use of the device, and the evaluation of the undesirable side-effects and of the acceptability … 613 unchanged words … Directive 90/385/EEC or Directive 93/42/EEC and for which the clinical evaluation:
is based on sufficient clinical data, and
is in compliance with the relevant product-specific CS for the clinical evaluation of that kind of device, where such a CS is available; or
(b) that are sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips or connectors 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. 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.
7. Cases in which paragraph 4 is not applied by virtue of paragraph 6 shall be justified in the clinical evaluation report by the manufacturer and in the clinical evaluation assessment report by the notified body.
8. Where justified in view … 465 unchanged words … regard to technical and scientific progress, adopt implementing acts to the extent necessary to resolve issues of divergent interpretation and of practical application. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 114(3).