European Commission Expands List of Class IIb Implantable Devices Exempt from Individual Technical Documentation Assessment
On 20 March 2026, the European Commission adopted a Delegated Regulation amending Regulation (EU) 2017/745 (MDR), expanding the list of Class IIb implantable devices that are exempt from the requirement to perform an assessment of technical documentation for every device.
What has changed?
Under Article 52(4) MDR, notified bodies are generally required to assess the technical documentation for each Class IIb implantable device as part of the conformity assessment procedure (Annex IX, Section 4).
However, certain devices—considered well-established technologies (WET)—are exempt from this requirement.
With this Delegated Regulation, the Commission has expanded the list of such exempted devices, based on experience gained with MDR implementation and following consultation with the Medical Device Coordination Group (MDCG).
According to the Commission, these devices meet WET criteria, including:
Common, simple and stable design
Well-known safety profile
Established clinical performance characteristics
Long history on the Union market
No association with safety issues
Updated list of exempted devices
The amended Article 52(4) now includes the following Class IIb implantable devices:
Sutures, staples, dental fillings, dental braces, tooth crowns
Screws, wedges, plates, wires, pins, clips, connectors
Cannulas, catheters, feeding tubes
Suture pledgets, sleeves, buttons
Gastrostomy buttons
Bone wax, bone fillers, bone substitutes
Stem centralisers, diaphyseal obturators
Radiography markers
Fiber ligatures, textile braids
Transpalatal distractors
Nails, anchors
Spinal posterior fixations
Dental implants, orthodontic devices, dental barriers
Suspensory fixations and cinches
Impact for manufacturers
For manufacturers of devices included in this list:
The conformity assessment procedure no longer requires notified bodies to assess the technical documentation for every individual device within the scope of this exemption
This exemption applies specifically to Annex IX, Section 4 MDR, within the broader conformity assessment framework
It is important to note that:
All other MDR requirements remain fully applicable, including:
Technical documentation (Annex II and III)
Clinical evaluation (Article 61 and Annex XIV)
Post-market surveillance and vigilance
Manufacturers should ensure that their devices clearly fall within the listed categories and align with the characteristics of well-established technologies, as described in MDCG guidance (e.g. MDCG 2020-6).
Entry into force
The Regulation will enter into force 20 days after its publication in the Official Journal of the European Union and will be directly applicable in all Member States.
Key takeaway
This amendment updates the scope of well-established technologies under MDR, clarifying which Class IIb implantable devices are exempt from the requirement for individual technical documentation assessment, based on their established safety and performance profile.
Read the full document below.
