Translated with AI
On March 20, 2026, the European Commission adopted two delegated regulations, C (2026) 1809 and C (2026) 1798, amending the MDR (EU) 2017/745 regulation by expanding the list of Well-Established Technologies (WET).
These acts reduce the bureaucratic and financial burden for technologies with proven safety and stable designs, by introducing specific exemptions from the clinical investigation obligation for implantable and Class III devices, as well as simplified technical documentation assessment procedures on a sampling basis for Class IIb devices.
Both regulations will enter into force 20 days after their publication in the Official Journal of the European Union (OJEU).
Regulation C (2026) 1798: exemption from Clinical Investigations
The regulation fully replaces the list referred to in Article 61(6)(b) MDR, including additional devices that may be considered WET. In addition to currently listed devices, such as sutures, staples, screws, and plates, the list now includes further types of devices, such as:
- Cardiovascular: catheters (port, balloon, coated), guidewires, leads, snares.
- Orthopaedics and Surgery: bone substitutes, anchors, nails, spinal fixation systems, embolic coils, and particles.
- Dentistry: dental implants, crowns, veneers, orthodontic appliances.
- Neurosurgery and others: ventricular drains, shunts, feeding tubes, reusable surgical instruments, radiopaque markers.
The Regulation clarifies that the exemption applies exclusively to the clinical investigation obligation; the obligation to plan, conduct, and document a complete clinical evaluation throughout the device’s lifecycle remains confirmed. In practice, under Article 61(6)(b) of the MDR, a manufacturer can avoid clinical investigations prior to placing on the market (and for its maintenance) only if a clinical evaluation is present, based on sufficient clinical data – including post-market surveillance data – and complies with any relevant Common Specifications (CS) (Art. 61(9) MDR).
In summary: for WET devices, new pre-market clinical investigations are not required (Art. 61(6)(b)), but a clinical evaluation based on sufficient clinical data remains mandatory (Art. 61(4)).
Regulation C (2026) 1809: simplification of technical assessment
Pursuant to Article 52(4) MDR, the Commission has expanded the list of Class IIb implantable Medical Devices exempted from the requirement of technical documentation assessment for every single device. Notified Bodies will no longer be required to examine every technical file but may proceed on a sampling basis, assessing only a representative selection of files within a product family.
New Class IIb devices added to the list include, among others: cannulas, catheters, feeding tubes, bone fillers and substitutes, radiopaque markers, posterior spinal fixation systems, dental implants, and orthodontic devices.
What to do now?
To benefit from these exemptions, manufacturers must verify whether their devices fall within the new lists and if they can effectively utilize them. It is also necessary to ensure that products meet the requirements set out in the MDCG 2020-6 guidance for Well-Established Technologies (WET):
- Common and stable design: widely used structure and materials, with limited evolutionary changes over time.
- Known safety profile: a history of use without systemic safety issues or recurring recalls.
- Standard of care: performance representing established clinical practice for the specific indication.
>>> Thema offers strategic regulatory consultancy services to support manufacturers in product portfolio mapping and defining the most effective strategy to access the new WET exemptions and simplified procedures.
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