Article 52.4 of the MDR requires, with limited exceptions, that each Class IIb implantable device be the subject of an individual conformity assessment. Article 52.5 of the Regulation provides an exemption from this obligation for “well-established technologies” that are used in other class IIb implantable devices, or where the exemption is justified in order to protect the health and safety of patients, users or other persons or other aspects of public health.
Commission Delegated Regulation (EU) 2026/1359 adds the following exemptions concerning Class IIb medical devices:
- sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips, connectors
- 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.’.
Article 61.8 of the MDR provides similar exemptions for “well-established technologies” that are used in implantable and Class III medical devices.
Commission Delegated Regulation (EU) 2026/1451 adds the following exemptions concerning implantable and Class III medical devices:
- dental implants
- orthodontic devices
- guidewires
- pacing wires and leads
- ventricular drains
- feeding tubes
- introducers and dilators
- bone substitutes and bone fillers
- embolisation coils and particles
- reusable surgical instruments
- spinal posterior fixation devices
- shunts
- internal defibrillation paddles
Both Regulations will apply from 19 July 2026.