EU MDR WET Exemptions Under Regulations 2026/1451 and 2026/1359

Commission Delegated Regulations (EU) 2026/1451 and (EU) 2026/1359 entered into force on 19 July 2026. Together, they expand two separate European Union Medical Device Regulation (MDR) exemptions for specified well-established technologies. One concerns when a clinical investigation is not mandatory for listed implantable and Class III devices. The other concerns whether a notified body must assess the technical documentation for every device within certain Class IIb implantable device groups.

The changes are important, but neither regulation creates a blanket exemption from clinical evidence, technical documentation, conformity assessment, or post-market obligations. Manufacturers must first confirm that the device falls within the relevant MDR class and an expressly listed device type, then document why the applicable conditions are met.

What changed under the two delegated regulations?

Before 19 July 2026, both provisions named only sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips, and connectors. The delegated regulations retain those device types and add the categories below.

Which Class IIb implantable devices were added under Regulation 2026/1359?

The new Article 52(4) list adds:

• cannulas and catheters;
• feeding tubes, suture pledgets, suture sleeves, suture buttons, and gastrostomy buttons;
• bone wax, bone fillers, bone substitutes, stem centralisers, and diaphyseal obturators;
• radiography markers and fiber ligatures;
• transpalatal distractors, nails, anchors, and spinal posterior fixations; and
• textile braids, dental implants, orthodontic devices, dental barriers, suspensory fixations, and cinches.

For a listed Class IIb implantable device using the Annex IX route, the amendment removes the Article 52(4) rule that otherwise makes the Section 4 technical-documentation assessment apply to every device. Manufacturers should not describe this as an exemption from technical documentation: the broader Article 52(4) conformity-assessment framework continues to apply.

Which implantable and Class III devices were added under Regulation 2026/1451?

The expanded Article 61(6)(b) list adds the following device types:

• cranial perforators, cranio-blades, catheter passers, patties and strips, and springs for skull enlargement;
• magnets for implantable pulse generators, port plugs, stylets and stylet guides, needles, needle holders, forceps, cannulas, and reusable surgical instruments;
• atrioseptostomy balloon catheters, catheters coated with anticoagulants, blood bags incorporating anticoagulants, port catheters, introducers, dilators, ventricular drains, and feeding tubes;
• suture pledgets, suture sleeves, suture buttons, gastrostomy buttons, and tubal extraluminal ligation devices;
• bone tacks, bone wax, bone fillers, bone substitutes, stem centralisers, diaphyseal obturators, radiography markers, fiber ligatures, transpalatal distractors, nails, anchors, spinal posterior fixations, and textile braids;
• dental implants, orthodontic devices, dental barriers, and dental veneers;
• suspensory fixations and cinches; and
• 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.

This is the controlling list of newly added types in Regulation 2026/1451. A device does not qualify merely because its technology appears similar to a listed product. The manufacturer must establish that the product is within the relevant implantable or Class III scope and the expressly listed device type.

What conditions apply to the clinical-investigation exemption?

Regulation 2026/1451 changes the list, not the conditions attached to Article 61(6)(b). For a listed device, the clinical evaluation must:

1. be based on sufficient clinical data; and
2. comply with the relevant product-specific common specifications, where such specifications are available.

Article 61(7) also requires the manufacturer to justify use of the exemption in the clinical evaluation report, and the notified body to justify it in the clinical evaluation assessment report. The regulation's recitals expressly confirm that manufacturers remain required to plan, conduct, and document a clinical evaluation under Article 61. The clinical evaluation must also continue to be updated through the device lifecycle with post-market clinical follow-up and post-market surveillance data as required by the MDR.

Pure Global's interpretation is that an existing clinical strategy should not be shortened solely because a product label or internal category resembles a term in the new list. The defensible sequence is to confirm classification and device-type identity, test the Article 61(6)(b) conditions against the available clinical data, and align the rationale with the notified body before changing an investigation plan.

What should manufacturers do now?

Manufacturers with potentially affected portfolios should separate the two decisions rather than treating them as one WET exemption:

1. Map the portfolio to the exact legal lists. Record the MDR class, implantable status, intended purpose, and the listed device term relied upon.
2. Reassess the clinical-investigation rationale. For Article 61(6)(b), document data sufficiency, any applicable product-specific common specifications, and the basis for the clinical evaluation report conclusion.
3. Revisit the conformity-assessment plan. For Class IIb implantable devices, confirm with the notified body how Regulation 2026/1359 changes the planned scope of technical-documentation sampling under the selected conformity-assessment route.
4. Keep the two exemptions distinct in procedures and contracts. A device may fall within one amended provision without satisfying the other, because the provisions address different classes, scopes, and decisions.
5. Retain lifecycle evidence. Neither act removes clinical-evaluation updates, PMCF, post-market surveillance, vigilance, or the need to maintain MDR-compliant technical documentation.

The official texts are Commission Delegated Regulation (EU) 2026/1451 and Commission Delegated Regulation (EU) 2026/1359. For the wider conformity-assessment context, see Pure Global's EU MDR consulting overview.