In March 2026 the EU issued two acts in quick succession that relax clinical investigation and technical documentation assessment requirements for certain products – good news for some Class III and Class IIb implantable medical devices.
The first act, C(2026) 1798 final, amends the MDR (Regulation (EU) 2017/745) to extend the list of device types in MDR Article 61, so that these Class III devices are exempt from the requirement to perform clinical investigations.
The second act, C(2026) 1809 final, amends the MDR (Regulation (EU) 2017/745) to extend the list of device types in MDR Article 52, so that these Class IIb devices are exempt from technical documentation assessment on a device-by-device basis.
C(2026) 1798 updates MDR Article 61 by listing more Class III and implantable devices as WET (Well-Established Technologies) products. For these products, the requirement for clinical investigations can be waived when performing clinical evaluation.
The Class III products originally exempt from clinical investigations under MDR Article 61 remain unchanged:
Sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors.
Class III products added by C(2026) 1798 final as exempt from clinical investigations:
Cranial perforators, cranial blades, catheter tunnelers, gauze pads and strips, magnets for implantable pulse generators, port plugs, stylets and stylet guides, needles, needle holders, trocars, atrial septostomy balloon catheters, catheters coated with anticoagulants, blood bags containing anticoagulants, port catheters, introducers, dilators, ventricular drains, feeding tubes, suture pads, suture sleeves, suture buttons, gastrostomy buttons, bone pins, bone wax, bone fillers, bone substitutes, intramedullary centralisers, diaphyseal occluders, radiological markers, fibre cerclages, extraluminal fallopian tube ligation devices, lumbar spreaders, intramedullary nails, anchors, posterior spinal fixation devices, textile braids, dental implants, orthodontic devices, dental barriers, dental veneers, suspension fixation devices and straps, reusable surgical instruments, springs for cranial expansion, guidewires, pressure guidewires, pacing leads and electrode leads, snares, lead caps, fixation and connection tools, endovascular embolisation coils, embolisation particles, cables, shunts and internal defibrillation paddles.
Link to the original text of C(2026) 1809 final:
C(2026) 1809 updates MDR Article 52, exempting more Class IIb implantable devices from technical documentation assessment on a device-by-device basis:
The Class IIb products originally exempt from per-device technical documentation assessment under MDR Article 52 remain unchanged:
Sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors.
Class IIb products added by C(2026) 1809 final as exempt from per-device technical documentation assessment:
Cannulas, catheters, feeding tubes, suture pads, suture sleeves, suture buttons, gastrostomy buttons, bone wax, bone fillers, bone substitutes, stem centralisers, diaphyseal occluders, radiological markers, fibre cerclages, palatal expanders, nails, anchors, posterior spinal fixation devices, textile braids, dental implants, orthodontic appliances, dental barriers, suspension fixation devices and straps.
Conclusion
This is a series of educational articles introducing regulations and standards of the FDA, NMPA, GMP, CE MDR/IVDR and MDSAP.
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EVERBIZ Certification Services (Shanghai) Co., Ltd. (EVERBIZ) is a professional compliance service platform for testing, certification, consulting and training of medical products, dedicated to helping leading medical R&D companies at home and abroad improve their compliance capabilities and competitiveness. The company has offices and branches in Shanghai (China), Hong Kong, Munich (Germany), Salzburg (Austria) and Thailand, covering nearly 25 industries of compliance products (such as medical devices, new energy, household appliances, lighting, tools, laboratory instruments, machinery, in vitro diagnostics, wireless products and reagents).
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