On 29 June 2026, the Official Journal of the EU released new revised requirements for medical devices on the Union market. With Commission Delegated Regulation (EU) 2026/1359 and Commission Delegated Regulation (EU) 2026/1451, the MDR introduces additions to:
- List of class IIb implantable devices exempted from the obligation to perform an assessment of the technical documentation for every device.
- List of implantable devices and class III devices exempted from the obligation to perform clinical investigations.
Class IIb implantable devices exempted from technical documentation assessment for every device
Second paragraph of Article 52(4) of the MDR was revised as follows:
‘However, for class IIb implantable devices, the assessment of the technical documentation as specified in Section 4 of Annex IX shall apply for every device, except for the following class IIb implantable devices:
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(a) |
sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips, connectors, |
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(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.’. |
Implantable devices and class III devices exempted from clinical investigations’ obligations
The following text replaces point (b) of Article 61(6) of the MDR:
‘(b) 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 and that are one of the following:
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(a) |
sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips, connectors, |
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(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.’. |
These two amendments add more devices to the already listed types in the second subparagraph of Article 52(4) as well as in point (b) of Article 61(6). In this context, experience with the MDR implementation has demonstrated that several other types of devices meet the criteria to be considered well-established technologies.
Questions? Contact us here or at mdlaw@obelis.net.
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