EU MDR Update – Dental Implants Added to the List of Well-Established Technologies (WET)
EU MDR Update – Dental Implants Added to the List of Well-Established Technologies (WET)
6 August 2026
On 29 June 2026, the European Commission adopted Commission Implementing Regulation (EU) 2026/1451, updating the list of Well-Established Technologies (WETs) eligible for the clinical investigation exemption provided under the Medical Device Regulation (EU) 2017/745 (MDR).
The amendment represents one of the most relevant regulatory developments of 2026 for manufacturers of implantable medical devices, as dental implants are now formally included within the Class III WET list.
What has changed?
Regulation (EU) 2026/1451 expands the list of technologies that are considered sufficiently established to qualify, under specific conditions, for the exemption from conducting a new clinical investigation under Article 61 of the MDR.
Among the newly included technologies are the following class III devices categories:
Dental implants
Orthodontic devices
Dental barriers
Dental veneers
Bone fillers and bone substitutes
Reusable surgical instruments
Various fixation systems, anchors, screws and implantable orthopaedic technologies
The updated list reflects technologies with extensive clinical use and well-established safety and performance profiles supported by long-term clinical experience.
What does this mean for dental implant manufacturers?
The inclusion of dental implants (and other class III devices) within the WET list does not automatically exempt every dental implant (and other class III devices) from clinical investigations.
Instead, it provides manufacturers with the possibility of relying on the exemption about clinical investigation provided by the MDR where all regulatory conditions are met.
Manufacturers must still demonstrate that:
the device falls within the recognised Well-Established Technology;
sufficient clinical evidence already exists;
the available evidence adequately demonstrates conformity with the applicable General Safety and Performance Requirements (GSPRs);
the clinical evaluation fully justifies why a new clinical investigation is not necessary.
In practice, this means that many manufacturers may be able to build their clinical evidence using existing clinical data, scientific literature, post-market surveillance information and equivalent clinical experience, provided that these data are robust and appropriate for the intended purpose.
What remains unchanged?
The publication of Regulation (EU) 2026/1451 does not reduce the overall clinical evidence requirements under the MDR.
Manufacturers are still expected to prepare:
a comprehensive Clinical Evaluation Report (CER);
an appropriate Post-Market Clinical Follow-up (PMCF) strategy where required;
sufficient objective evidence demonstrating the device's safety, clinical performance and benefit-risk profile.
Notified Bodies will continue to assess whether the manufacturer's justification for relying on the WET exemption is scientifically and clinically sound.
Why this update matters
For manufacturers of dental implants, the amendment provides greater regulatory certainty and may simplify conformity assessment for future MDR submissions.
Potential benefits include:
clearer regulatory expectations;
reduced need for prospective clinical investigations where adequately justified;
greater reliance on existing clinical evidence;
potentially shorter regulatory timelines and lower development costs.
However, eligibility should always be assessed on a device-by-device basis, taking into account the specific design, intended purpose, clinical claims and available clinical evidence.
Our perspective
The publication of Regulation (EU) 2026/1451 reflects the European Commission's continued effort to focus clinical investigations on innovative technologies while recognising the extensive clinical history of well-established devices.
Manufacturers should nevertheless avoid assuming that inclusion in the WET list automatically guarantees exemption from clinical investigations. Instead, organisations should review their clinical evaluation strategy, confirm that sufficient evidence is available and ensure that their Technical Documentation clearly supports the chosen regulatory pathway.
For companies currently preparing MDR submissions for dental implant systems, this regulatory update may represent an opportunity to optimise both regulatory planning and resource allocation while maintaining full compliance with the MDR.
Reviewed by Sebastiano Lodi, Senior Q&RA Consultant
Sources: Regulation (EU) 2026/1359 and 2026/1451, MDR Article 61, and Annex XIV