European Commission expands list of well-established technologies under MDR
The European Commission has published two delegated acts that expand the list of well-established technologies (WET) under the Medical Devices Regulation (MDR) that are exempt from conducting clinical investigations and technical assessments. The first regulation applies to implantable devices and Class III devices, while the second regulation focuses on Class IIb implantable devices.
The delegated acts broaden the list of WET products eligible for exemption from clinical investigations and provide technical documents under MDR compared to a reform measure published in December 2025. (RELATED: EU Commission proposes major reforms to MDR, Regulatory Focus 18 December 2025)
The proposed MDR revision would define WETs as devices that belong to a generic device group, which fulfills the following criteria: it has a single, common and stable design, it has not been associated with safety issues in the past, it has well-known clinical performance characteristics and comprises standard of care devices with little evolution in indications and state of the art, and it has a long history on the EU market. It also sets out a limited number of devices eligible for exemption.
The expanded list was developed by a task force of national experts from the Medical Device Coordination Group (MDCG) in 2025, following a call for evidence that allowed stakeholder input, according to a Commission announcement.
The first delegated act concerns implantable and class III WET devices that are exempt from clinical investigations. The list now includes sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips, and connectors. It also adds cranial perforators, cranio-blades, and catheter passes.
The text notes that “although manufacturers are exempted from the obligation to perform clinical investigations for the types of implantable devices and class III devices listed in this Regulation, they are nonetheless required to plan, conduct and document a clinical evaluation in accordance with Article 61 of Regulation (EU) 2017/745 for those devices.”
The other delegated act expands the list of Class IIb implantable devices exempt from technical documentation assessment. The list now includes sutures, staples, dental fillings, dental braces, tooth crowns, screws, and wedges, catheters and feeding tubes.
Erik Vollebregt, a partner at Axon Lawyers, stated that the issuance of these regulations is "absolutely a positive development for manufacturers. The lists provide for certainty."
Yet he pointed out that under the proposed MDR revision, WET is expected to change from a list-based system to a definition-based system. Vollebregt noted that “not everyone is happy with that proposed definition.” He noted that “notified bodies think that the definition is potentially too broad and will invite a lighter touch on devices that should not merit a WET treatment.”
The amending legislation was published in the Official Journal on Monday. The regulations are scheduled to go into effect in 20 days on 24 July.
Commission regulation on implantable and class III devices; Commission regulation on class IIb devices
