The European regulatory landscape for medical devices is undergoing a fundamental transformation toward simplification. On June 29, 2026, the European Commission has published two Delegated Acts in the Official Journal of the EU. These acts expand the lists of devices considered Well-Established Technologies (WET), marking a concrete step to reduce administrative burdens without compromising safety.
These measures, paired with the broader reform proposal COM/2025/1023 and recent positions from Notified Bodies (Team-NB), aim to make the European Union more competitive and prevent the risk of shortages for critical devices on the market.
Below, we analyze the key points of this evolution and what it means for the sector.
What is a “Well-Established Technology device”?
The new reform proposal aims to insert a formal definition directly into Article 2 (point 72) of the MDR. According to the established criteria, a device is classified as WET if:
- It has a simple, common, and stable design.
- It has a long history on the Union market.
- It possesses well-known clinical performance characteristics and represents the “standard of care” with little evolution in indications.
- It has not been associated with safety issues in the past.
What are the main novelties of the new framework?
The heart of the revision is the shift from static lists to a more flexible and dynamic system. While the June 2026 Delegated Acts have already updated the current lists, the COM/2025/1023 proposal will allow the Commission to update the list of WET devices in the future through implementing acts.
A crucial novelty, supported by Team-NB, is the introduction of risk-adaptive surveillance. This approach ensures that surveillance by Notified Bodies is no longer rigidly fixed but is instead proportionate to the risk of the device and the manufacturer’s demonstrated compliance history.
Adaptive Surveillance: How will the role of Notified Bodies change?
According to the Team-NB position paper and the ongoing reform, the system will evolve toward dynamic monitoring that includes:
- Periodic Reviews instead of Recertification: The maximum 5-year validity of certificates would be removed and replaced by periodic reviews proportionate to the risk of the device.
- Surveillance Levels: Manufacturers (or device groups) would be assigned to different levels (initial/enhanced, medium, or reduced) based on vigilance data and post-market performance.
- “For-Cause” Audits: The intensity of controls can be immediately increased (re-escalation) in the event of serious incidents or recurring non-conformities.
- Focus for WET: For established technologies, audits may benefit from reduced times and focus more heavily on post-market surveillance (PMS) technical documentation.
What concrete advantages do these simplifications offer?
For devices classified as WET, manufacturers can benefit from more proportionate requirements, including:
- Exemption from clinical investigations: For listed implantable and Class III devices, clinical evaluation can be based on sufficient clinical data and compliance with Common Specifications (CS).
- Simplified technical documentation assessment: For Class IIb implantable devices considered WET, the Notified Body can perform the assessment on a sampling basis (one representative device per generic device group).
- Reduced vigilance burdens: The frequency for updating Periodic Safety Update Reports (PSUR) is being made more flexible for lower risk classes.
Which devices have been included in the new lists?
Delegated Regulations (EU) 2026/1359 and (EU) 2026/1451 have extended WET status to products such as:
- Sutures, staples, dental fillings, and orthodontic braces.
- Cannulas, catheters, and feeding tubes.
- Bone substitutes, nails, anchors, and reusable surgical instruments.
Why is this reform vital for SMEs?
Small and medium-sized enterprises benefit directly from reduced compliance costs. The proposal includes significant fee reductions (at least 50% for micro-enterprises) for access to expert panels and certification procedures. Furthermore, the EMA will establish a dedicated support office for SMEs to help them navigate MDR requirements.
What to expect for the future?
While the technical exemptions for the new WET lists are already operational, the structural reform (COM/2025/1023) is continuing its legislative path, with adoption expected in the second quarter of 2027.
At Chemsafe, we help companies monitor these regulatory changes and implement surveillance systems that meet the new adaptability criteria. From defining clinical evaluation strategies to supporting the identification of WET devices, we transform regulatory challenges into growth opportunities.
Contact us to let us know about your project.
