in force 2026-07-19 MODIFIED+594 −136§
Amended by Regulation (EU) 2026/1359 32026R1359 · Regulation (EU) 2026/1451 32026R1451
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).