in force 2026-07-19
02017R0745-20260101 → 02017R0745-20260719
Amended by Regulation (EU) 2026/1359 32026R1359 · Regulation (EU) 2026/1451 32026R1451
detected 2026-09-11
2 provisions touched — 2 substantive, 0 date-only, 0 with no text, 0 disputed · every change carries an explanation that passed its citation check
MODIFIED +594 −136 Art. 52 Conformity assessment procedures§
applies from: unchanged
The second subparagraph of paragraph 4 restructures the list of exempted class IIb implantable devices into two lettered sub-lists, labelled (a) and (b), instead of a single unlettered list of exceptions.
The (a) sub-list retains the previously named devices such as sutures, staples, dental fillings and related items, while the new (b) sub-list adds a further set of named devices, including cannulas, catheters, feeding tubes, various suture and bone-related items, markers, distractors, nails, anchors, spinal fixations, textile braids, dental implants, orthodontic devices, dental barriers, and suspensory fixations and cinches, all now also excepted from the per-device technical documentation assessment requirement.
Cited: Art. 52, v1 · Art. 52, v2
text before / after
02017R0745-20260101 → 02017R0745-20260719
Article 52
Conformity assessment procedures
1. Prior to placing a device on the market, manufacturers shall undertake an assessment of the conformity of that device, in accordance with the applicable conformity assessment procedures set out in Annexes IX to XI.
2. Prior to putting into service a device that is not placed on the market, manufacturers shall undertake an assessment of the conformity of that device, in accordance with the applicable conformity assessment procedures set out in Annexes IX to XI.
3. Manufacturers of class III devices, other than custom-made or investigational devices, shall be subject to a conformity assessment as specified in Annex IX. Alternatively, the manufacturer may choose to apply a conformity assessment as specified in Annex X coupled with a conformity assessment as specified in Annex XI.
4. Manufacturers of class IIb devices, other than custom-made or investigational devices, shall be subject to a conformity assessment as specified in Chapters I and III of Annex IX, and including an assessment of the technical documentation as specified in Section 4 of that Annex of at least one representative device per generic device group.
However, for class IIb implantable devices, except sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors, the assessment of the technical documentation as specified in Section 4 of Annex IX shall apply for every device. device, except for the following class IIb implantable devices:
(a) sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips, connectors,
(b) 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.
Alternatively, the manufacturer may choose to apply a conformity assessment based on type examination as specified in Annex X coupled with a conformity assessment based on product conformity verification as specified in Annex XI.
5. Where justified in view of well-established … 897 unchanged words … Sections 3.4 and 4.3 of Annex IX, Section 3 of Annex X and Section 15 of Annex XI.
The implementing acts referred to in the first subparagraph shall be adopted in accordance with the examination procedure referred to in Article 114(3).
MODIFIED +1,263 −139 Art. 61 Clinical evaluation§
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).
The full entry, with the citation mapping v1 = 02017R0745-20260101, v2 = 02017R0745-20260719, is committed at eu/32017R0745/CHANGELOG.md.