The European medical device landscape has just shifted. With the publication of Commission Delegated Regulation (EU) 2026/1451, the European Commission has officially expanded the list of implantable and Class III devices exempted from the obligation to perform clinical investigations.
This amendment to the Medical Device Regulation (MDR) 2017/745 is a pragmatic step toward reducing the investigative burden for technologies the Commission now classifies as “well-established.”
What Makes a Device “Well-Established”?
The decision to exempt certain high-risk devices was not made lightly. Following a wide consultation with the Medical Device Coordination Group (MDCG), the Commission identified specific technologies that meet a high bar for clinical history and stability.
To qualify for these exemptions under the new regulation, a device type must demonstrate:
Simple & Stable Design
A common architectural framework that has not seen radical changes over time.
Proven Safety Track Record
A long history on the Union market without being associated with past safety issues.
Known Performance
Well-known clinical performance characteristics, where the technology is considered the standard of care.
Mature Indications
Little to no evolution in clinical indications or the current state of the art.
Which Devices Are Now Exempt?
Article 1 of the new regulation replaces the previous list in Article 61(6), point (b) of the MDR with a significantly more comprehensive directory, grouped below by clinical field for readability.
Dental & Orthodontic Established list
- Dental implants
- Orthodontic devices
- Dental fillings
- Dental braces
- Tooth crowns
- Dental barriers
- Dental veneers
- Transpalatal distractors
Fixation, Fasteners & Structural Implants Established list
- Sutures
- Staples
- Screws
- Wedges
- Plates
- Wires
- Pins
- Clips
- Connectors
- Nails
- Anchors
- Spinal posterior fixations
- Bone tacks
- Bone wax
- Bone fillers
- Bone substitutes
- Stem centralisers
- Diaphyseal obturators
- Textile braids
- Fixation and connector tools
Catheters, Tubes & Vascular Access New additions
- Atrioseptostomy balloon catheters
- Catheters coated with anticoagulants
- Port catheters
- Port plugs
- Introducers
- Dilators
- Catheter passers
- Feeding tubes
- Gastrostomy buttons
- Blood bags incorporating anticoagulants
- Guidewires
- Pressure wires
Surgical & Neurosurgical Instruments New additions
- Cranial perforators
- Cranio-blades
- Ventricular drains
- Reusable surgical instruments
- Springs for skull enlargement
- Patties and strips
- Stylets and stylet guides
- Needles
- Needle holders
- Forceps
- Cannulas
- Snares
Suture Accessories & Ligation New additions
- Suture pledgets
- Suture sleeves
- Suture buttons
- Fiber ligatures
- Tubal extraluminal ligation devices
- Suspensory fixations and cinches
Cardiac & Electrophysiology New additions
- Magnets for implantable pulse generators
- Pacing wires and leads
- Lead caps
- Endovascular embolisation coils
- Embolisation particles
- Cables
- Shunts
- Internal defibrillation paddles
Imaging & Radiographic Markers New additions
- Radiography markers
Note: this list reflects the categorisation used in this article for readability; the legal text itself (Article 1) presents the devices as a single, undivided list under Article 61(6), point (b) of the MDR.
The Catch: Clinical Evaluation Is Still Mandatory
It is vital for manufacturers to understand that an exemption from clinical investigations is not a total exemption from clinical oversight.
Manufacturers of the exempt devices listed above are still required to plan, conduct, and document a clinical evaluation in accordance with Article 61 of Regulation (EU) 2017/745.
This evaluation must be based on sufficient clinical data and remain in compliance with any relevant product-specific Common Specifications (CS) that may be available.
Looking Ahead
Regulation (EU) 2026/1451 was published in the Official Journal on 29 June 2026 and entered into force on the twentieth day following publication — 19 July 2026.
For manufacturers of the newly listed devices, this update provides a clearer pathway to market by acknowledging the maturity of their technologies. However, the requirement for robust clinical evaluation remains the cornerstone of ensuring patient safety in the European Union.
Watch: Understanding the Update
A closer look at the regulation and its practical impact on clinical strategy.