European Commission Expands Well-Established Technology Lists Under MDR

The European Commission has published two Delegated Regulations that materially expand the categories of medical devices benefiting from lighter conformity assessment obligations under Regulation (EU) 2017/745 (MDR). Commission Delegated Regulation (EU) 2026/1359 of 20 March 2026 amends Article 52(4) MDR, and Commission Delegated Regulation (EU) 2026/1451 of 20 March 2026 amends Article 61(6), point (b) MDR. Both were published in the Official Journal on 29 June 2026 and entered into force on 19 July 2026. Together, they codify a broader range of “well-established technologies,” meaning devices with common, simple, and stable designs, well-known safety and clinical performance, and a long history on the Union market.

Background

Article 52(4) MDR requires Notified Bodies (NBs), when conducting conformity assessment of class IIb implantable devices, to assess the technical documentation for every device in accordance with Annex IX, Section 4. The Regulation carves out a narrow list of well-established device types from this per-device obligation. Article 61(6)(b) MDR similarly exempts a defined list of implantable and class III devices from the obligation to perform clinical investigations, provided the clinical evaluation is based on sufficient clinical data and complies with any relevant product-specific common specification (CS). 

Both lists were originally limited to a small set of devices, namely sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips, and connectors. Following consultation with the Medical Device Coordination Group, the Commission concluded that a wider range of device types also meets the “well-established” criteria and should benefit from the same treatment. The two Delegated Regulations codify that expansion. The two amended lists overlap substantially but are structurally independent: each provision must be read on its own terms. 

Key Points

• Article 52(4) list expanded (Regulation (EU) 2026/1359): The list of class IIb implantable devices exempted from per-device technical documentation assessment now additionally includes cannulas, catheters, feeding tubes, suture pledgets, suture sleeves, suture buttons, gastrostomy buttons, bone wax, bone fillers, bone substitutes, stem centralizers, 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.
• Article 61(6)(b) list expanded (Regulation (EU) 2026/1451): The list of implantable and class III devices exempted from the obligation to perform clinical investigations now includes cannulas, feeding tubes, suture pledgets, suture sleeves, suture buttons, gastrostomy buttons, bone wax, bone fillers, bone substitutes, stem centralizers, 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, as well as items unique to Article 61(6)(b) that do not appear in Article 52(4): cranial perforators, cranio-blades, catheter passers, patties and strips, magnets for implantable pulse generators, port plugs, stylets and stylet guides, needles, needle holders, forceps, atrioseptostomy balloon catheters, catheters coated with anticoagulants, blood bags incorporating anticoagulants, port catheters, introducers, dilators, ventricular drains, bone tacks, tubal extraluminal ligation devices, dental veneers, reusable surgical instruments, springs for skull enlargement, guidewires, pressure wires, pacing wires and leads, snares, lead caps, fixation and connector tools, endovascular embolization coils, embolization particles, cables, shunts, and internal defibrillation paddles.
• Overlap between the two lists: Many device types appear in both amended lists. Where a device falls within both, manufacturers benefit from both the per-device technical documentation assessment exemption under Article 52(4) and the clinical investigation exemption under Article 61(6)(b). Where a device falls within only one, only the corresponding exemption applies.
• Effective date: Both Regulations entered into force on 19 July 2026, being the twentieth day following publication in the Official Journal. The amended lists apply directly from that date in all Member States. No transitional carve-out is provided in the text.
• Clinical evaluation obligation is unchanged: Recital 5 of Regulation (EU) 2026/1451 makes this explicit. Exemption from clinical investigation does not exempt manufacturers from planning, conducting, and documenting a clinical evaluation under Article 61 MDR. Post-market clinical follow-up (PMCF) and post-market surveillance obligations likewise remain fully applicable. 
• Conditional exemption from clinical investigation: The Article 61(6)(b) exemption applies where the clinical evaluation is based on sufficient clinical data and the device complies with the relevant product-specific CS, where such a CS is available. For most of the newly listed device types no product-specific CS currently exists, so the exemption operates unconditionally today; this could change if the Commission adopts product-specific CS in future.
• Classification, safety, and other MDR obligations unchanged: The Regulations do not alter device classification, general safety and performance requirements, NB oversight of the QMS, or any other MDR obligation. They narrow specific conformity assessment steps, nothing more.

Broader Implications

The practical effect for manufacturers of the newly listed device types is a lighter and more predictable route through MDR conformity assessment. For class IIb implantables now covered by Article 52(4), the NB is no longer required to sample the technical documentation on a per-device basis under Annex IX, Section 4, which should reduce assessment time and cost. For devices now covered by Article 61(6)(b), the removal of the clinical investigation obligation removes one of the most resource-intensive steps in bringing a class III or implantable device to market, provided the clinical evaluation itself remains robust.

The most common misreading of Article 61(6)(b) is to conflate exemption from clinical investigations with exemption from clinical evaluation. They are not the same, and the Commission has taken the unusual step of stating this expressly in the recitals. Manufacturers relying on the exemption should ensure their clinical evaluation strategy, including data sufficiency, equivalence claims where relied upon, and PMCF planning, is fully documented and defensible.

Manufacturers should also note that the two expanded lists are not identical. A device may fall within the Article 61(6)(b) list but not the Article 52(4) list, or vice versa, depending on its classification. Portfolio mapping should therefore be done against each list separately.

The Swiss position is a separate question. Switzerland’s MedDO references MDR, but because the EU and Swiss Mutual Recognition Agreement for medical devices has been suspended since May 2021, EU Delegated Regulations adopted after that date do not automatically apply in Switzerland. Whether Swissmedic will recognize these specific exemptions for devices placed on the Swiss market depends on adoption via Swiss ordinance amendment or Swissmedic communication. Manufacturers with Swiss market presence should verify the Swiss position before relying on the exemptions for CH-market submissions.

What This Means for Manufacturers

• Map your portfolio against both expanded lists. Identify which of your class IIb implantable devices now fall within Article 52(4), and which of your implantable and class III devices now fall within Article 61(6)(b). The lists overlap but are not identical.
• Reassess conformity assessment strategy where relevant. For devices now within scope of the exemptions, discuss with your NB how the amended provisions affect ongoing assessments, planned submissions, and certificate renewals.
• Do not treat exemption from clinical investigations as exemption from clinical evaluation. Ensure clinical evaluation, PMCF, and post-market surveillance documentation remain robust and Article 61 compliant. This is where most audit findings are likely to arise.
• Watch for product-specific common specifications. The Article 61(6)(b) exemption is conditional on compliance with any applicable product-specific CS. Track future Commission implementing acts that may introduce CS for the newly listed device types.
• Update internal procedures and technical documentation references. Ensure conformity assessment route decision documents, clinical evaluation plans, and QMS procedures reflect the amended lists from 19 July 2026 onward.

How MedEnvoy Can Support 

MedEnvoy monitors and interprets MDR and IVDR developments so that manufacturers can act on regulatory change with confidence. The expansion of the Article 52(4) and Article 61(6)(b) lists is a meaningful shift in the conformity assessment landscape for a wide range of device types, and the practical consequences for submission strategy, clinical evaluation planning, and Swiss market access need to be worked through device by device.

Our team can support portfolio mapping against the amended lists, review of clinical evaluation strategy in light of the revised clinical investigation exemption, and assessment of Swiss market implications alongside EU Authorized Representative services. To discuss how these changes affect your devices, contact us here.