Two new delegated acts under the EU Medical Device Regulation (MDR)—C (2026) 1798 and C (2026) 1809—have been adopted, introducing important updates for manufacturers of certain categories of medical devices.
Both acts focus on well-established technologies (WET): devices that are widely recognised as safe and effective due to their simple, stable design, long-standing clinical use, and well-documented performance. These are typically products that have changed little over time, with risks and benefits that are already well understood within the medical community.
Taken together, the measures aim to streamline regulatory requirements for such devices, reducing unnecessary administrative burden while maintaining the EU’s high standards for safety and performance.
C (2026) 1798: Expanded Exemptions from Clinical Investigations
The first delegated act, C (2026) 1798, expands the scope of devices that may be exempt from the obligation to perform clinical investigations.
Under the MDR framework, certain devices can already rely on existing clinical data where sufficient evidence from prior use is available. This new act builds on that principle, extending the exemption—particularly for implantable and Class III devices—so that more products may benefit from this simplified pathway.
This development follows extensive consultation throughout 2025 with regulatory experts, national authorities, and stakeholders within the Medical Device Coordination Group (MDCG). The objective is to avoid duplication of clinical testing while ensuring that safety and performance requirements remain fully met.
Key Regulatory Update
As part of this act, Article 61(6)(b) of the MDR has been revised. The updated provision clarifies that exemptions apply to devices supported by sufficient clinical data and compliant with any relevant Common Specifications (CS).
The revised structure introduces two categories of devices:
Part A retains the original list already included in the MDR, such as:
(a) sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips, connectors,
Part B introduces a significantly expanded list of additional devices, including:
(b) cranial perforators, cranio-blades, catheter passers, patties and strips, magnets for implantable pulse generators, port plugs, stylets and stylet guides, needles, needle holders, forceps, cannulas, atrioseptostomy balloon catheters, catheters coated with anticoagulants, blood bags incorporating anticoagulants, port catheters, introducers, dilators, ventricular drains, feeding tubes, suture pledgets, suture sleeves, suture buttons, gastrostomy buttons, bone tacks, bone wax, bone fillers, bone substitutes, stem centralisers, diaphyseal obturators, radiography markers, fiber ligatures, tubal extraluminal ligation devices, transpalatal distractors, nails, anchors, spinal posterior fixations, textile braids, dental implants, orthodontic devices, dental barriers, dental veneers, suspensory fixations and cinches, reusable surgical instruments, springs for skull enlargement, guidewires, pressure wires, pacing wires and leads, snares, lead caps, fixation and connector tools, endovascular embolisation coils, embolisation particles, cables, shunts and internal defibrillation paddles.
In practical terms, this expansion allows manufacturers of many well-understood devices to rely on existing clinical evidence, potentially accelerating market access while maintaining robust oversight.
The delegated act can be accessed using the following link
C (2026) 1809: Simplified Assessment for Class IIb Implantable Devices
The second delegated act, C (2026) 1809, focuses on simplifying conformity assessment procedures for certain Class IIb implantable devices.
Under Article 52(4) of Regulation (EU) 2017/745, some well-established technologies already benefit from exemptions from the requirement for a notified body to assess technical documentation for every individual device. Article 52(5) empowers the European Commission to expand this list further.
This delegated act applies that provision by extending the exemption to additional devices.
Key Regulatory Update
The amendment revises Article 52(4), confirming that while technical documentation assessment remains the default requirement for Class IIb implantable devices, exemptions apply to specific categories.
The revised structure introduces two categories of devices:
Part A retains the original list already included in the MDR, such as:
(a) sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips, connectors,
Part B introduces a significantly expanded list of additional devices, including:
(b) cannulas, catheters, feeding tubes, suture pledgets, suture sleeves, suture buttons, gastrostomy buttons, bone wax, bone fillers, bone substitutes, stem centralisers, diaphyseal obturators, radiography markers, fiber ligatures, transpalatal distractors, nails, anchors, spinal posterior fixations, textile braids, dental implants, orthodontic devices, dental barriers, suspensory fixations and cinches.
The delegated act can be accessed using the following link
By expanding these categories, the act enables a more proportionate regulatory approach, focusing notified body scrutiny where it is most needed while easing requirements for technologies with a well-established safety profile.
Together, these delegated acts signal a continued shift toward a more risk-based and proportionate implementation of the MDR. By recognising the strong clinical history of well-established technologies, the European Commission is seeking to balance regulatory rigour with practical efficiency.
For manufacturers, the changes may translate into more streamlined pathways to market. For healthcare systems and patients, they are expected to support continued access to trusted and widely used medical technologies—without compromising safety.
