EU MDR Well-Established Technologies (WET): Expanded Device List 2026 — Delegated Acts C(2026) 1798 & 1809
On March 20, 2026, the European Commission adopted two delegated regulations expanding the Well-Established Technology (WET) list under EU MDR. C(2026) 1798 exempts additional implantable and Class III devices from clinical investigations. C(2026) 1809 simplifies conformity assessment for Class IIb implantable devices. This guide covers what changed, which devices qualify, WET criteria, and practical steps for manufacturers.
What Happened
On March 20, 2026, the European Commission adopted two delegated regulations under the Medical Device Regulation (EU) 2017/745 that materially expand regulatory relief for manufacturers of devices classified as Well-Established Technologies (WET):
- C(2026) 1798 — Expands the list of implantable and Class III devices exempt from the obligation to perform clinical investigations under Article 61(6)(b).
- C(2026) 1809 — Expands the list of Class IIb implantable devices exempt from per-device technical documentation assessment under Article 52(4).
Both regulations enter into force 20 days after publication in the Official Journal of the European Union.
The original MDR listed 12 device types as WET. The expanded list now covers approximately 67 device types, marking the most significant update to clinical evidence requirements since MDR came into full application.
What Are Well-Established Technologies (WET)
WET refers to devices that meet the criteria set out in MDCG 2020-6:
- Common, simple, and stable design with little evolution over time
- Well-known safety profile with no history of significant safety issues
- Well-known clinical performance characteristics that are standard of care
- Long history on the EU market with established clinical use
Before these delegated acts, the MDR itself listed only these 12 WET device types in Article 61(6)(b): sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips, and connectors.
C(2026) 1798: Expanded Clinical Investigation Exemptions
What It Changes
This regulation replaces the existing Article 61(6)(b) list entirely with a new, expanded version organized into two categories.
Category (a) retains the original 12 device types from the MDR: sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips, and connectors.
Category (b) adds a substantial number of new device types now exempt from the obligation to conduct clinical investigations. The complete expanded list of newly added types includes:
- Orthopedic devices: Intramedullary nails, bone anchors, bone tacks, spinal posterior fixation systems, textile braids, stem centralizers, diaphyseal obturators, cranial perforators, cranio-blades, springs for skull enlargement
- Soft tissue and wound devices: Suture pledgets, suture sleeves, suture buttons, fiber ligatures, gastrostomy buttons, tubal extraluminal ligation devices
- Dental devices: Dental implants, orthodontic devices, dental barriers, dental veneers
- Surgical instruments: Cannulas, catheter passers, feeding tubes, needles, needle holders, forceps, reusable surgical instruments, stylets and stylet guides
- Bone-related devices: Bone wax, bone fillers, bone substitutes, patties and strips
- Cardiovascular devices: Atrioseptostomy balloon catheters, catheters coated with anticoagulants, blood bags incorporating anticoagulants, port catheters, introducers, dilators, guidewires, pressure wires, pacing wires and leads, snares, lead caps, fixation and connector tools, endovascular embolisation coils, embolisation particles, cables, shunts, internal defibrillation paddles
- Neurological devices: Ventricular drains, magnets for implantable pulse generators, port plugs
- Other: Radiography markers, transpalatal distractors, suspensory fixations and cinches
The original Article 61(6)(b) listed 12 device types. The expanded list now covers approximately 67 device types in total.
What About Devices Not Explicitly Listed?
Article 61(8) empowers the Commission to expand the WET list to include devices "similar" to those already listed. If your device is not explicitly named but is similar in design, function, and risk profile to a listed WET device type, you may still qualify for the exemption.
To make this case, manufacturers should:
- Document the similarity assessment in the clinical evaluation report (CER) and technical file
- Demonstrate that the device shares the same common, simple, and stable design characteristics as the listed type
- Provide evidence that the safety profile and clinical performance are equally well-established
- Discuss the similarity rationale with the Notified Body before relying on the exemption
Implant Card Requirements Are Unchanged
These delegated acts do not modify the Article 18 implant card requirements. The list of devices exempt from implant card obligations under Article 18(3) was not expanded by C(2026) 1798 or C(2026) 1809. Manufacturers of newly listed WET devices that are implantable must still provide implant cards to patients, even though they may be exempt from clinical investigations.
Competent authorities have raised concerns about the gap between the expanded clinical investigation exemption list and the unchanged implant card exemption list. Further MDCG action on implant cards may follow.
Critical Nuance: Clinical Evaluation Is Still Required
The clinical investigation exemption does not remove the obligation to conduct a clinical evaluation. Recital (5) of the regulation is explicit: manufacturers must still plan, conduct, and document a clinical evaluation in accordance with Article 61 MDR.
The distinction matters:
| Obligation | WET Devices | Non-WET Devices (Implantable / Class III) |
|---|---|---|
| Clinical evaluation (Article 61) | Required | Required |
| Clinical investigation | Exempt (if sufficient clinical data exists) | Required (default rule under Article 61(4)) |
| Post-market clinical follow-up | Required per PMS plan | Required per PMS plan |
For WET devices, the clinical evaluation pathway shifts from generating new clinical investigation data to compiling and appraising existing evidence — literature, post-market surveillance data, registries, and established clinical practice. Manufacturers still need a robust clinical evaluation report (CER), but they can build it on existing data sources rather than conducting new studies.
Conditions for Using the Exemption
The exemption under Article 61(6)(b) applies only when all three conditions are met:
- The device type is listed in the updated Article 61(6)(b)
- The clinical evaluation is based on sufficient clinical data
- The device complies with any relevant product-specific Common Specifications (CS), where they exist
If a manufacturer cannot demonstrate sufficient clinical data from existing sources, a clinical investigation may still be necessary despite the device being listed as WET.
C(2026) 1809: Simplified Conformity Assessment for Class IIb Implantables
What It Changes
Under Article 52(4), certain WET devices already benefit from an exemption from the requirement for a Notified Body to assess technical documentation for every individual device. Instead, the Notified Body may assess technical documentation on a sampling basis — reviewing a representative selection of files within a product family rather than each one individually.
C(2026) 1809 expands the list of Class IIb implantable devices eligible for this simplified assessment by adding:
- 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 fixation systems
- Textile braids
- Dental implants, orthodontic devices, dental barriers
- Suspensory fixations and cinches
Practical Impact
For manufacturers of these devices, the benefit is meaningful:
- Reduced conformity assessment costs — Notified Bodies can sample rather than review every technical file
- Faster time to market — Less documentation review time per device variant
- Lower ongoing compliance burden — Product line extensions and similar devices face streamlined assessment
The sampling approach means the Notified Body reviews a representative subset of technical files to verify that the manufacturer's quality system produces consistent, compliant documentation. This is particularly beneficial for manufacturers with large product families of similar WET devices.
How to Determine If Your Device Qualifies
Step 1: Check the Device Type List
Compare your device against the updated Article 61(6)(b) list (for clinical investigation exemption) and Article 52(4) list (for simplified conformity assessment). The lists are organized by device type, not by individual product name.
Step 2: Verify WET Criteria (MDCG 2020-6)
Even if your device type appears on the list, confirm it meets the WET criteria:
- Is the design common, simple, and stable with minimal evolution?
- Is the safety profile well-known with no significant safety concerns?
- Is the clinical performance well-established as standard of care?
- Does the device have a long history on the EU market?
If your device incorporates novel features, new materials, or significantly changed design elements, it may not qualify as WET even if the device type is listed.
Step 3: Assess Clinical Data Availability
The exemption from clinical investigations only applies if sufficient clinical data exists. Evaluate whether you have:
- Published clinical literature covering your device type
- Post-market surveillance data from prior marketing
- Registry data or real-world evidence
- Established clinical practice guidelines referencing your device type
Step 4: Consult Your Notified Body
Even though the delegated acts create a legal pathway for exemption, in practice, Notified Bodies will want to see your justification. Early engagement is critical. Present your WET rationale, clinical data compilation strategy, and how you plan to structure the CER using existing evidence.
Impact on Clinical Evaluation Reports
For manufacturers of newly listed WET devices, the CER approach changes:
| CER Element | Before WET Listing | After WET Listing |
|---|---|---|
| Clinical investigation data | May have been required | Not required (if sufficient existing data) |
| Literature search | Required | Required — now the primary evidence source |
| Equivalence argument | If applicable | If applicable — still a valid pathway |
| Post-market data | Supporting role | Can be primary evidence |
| State of the art review | Required | Required |
| Benefit-risk assessment | Required | Required |
The depth and rigor of the clinical evaluation itself is not reduced. The standard of clinical evidence remains high. What changes is the route to generating that evidence — from prospective clinical investigation to systematic compilation and appraisal of existing data.
Relationship to the Broader MDR Simplification Effort
These delegated acts are separate from, but complementary to, the European Commission's broader proposal to amend the MDR and IVDR (COM(2025) 1023), which includes provisions for:
- Risk-based conformity assessment cycles
- Expanded equivalence data use
- Software classification clarifications
- In silico data acceptance
The WET delegated acts are already adopted and entering into force. The broader simplification proposal is still working through the legislative process and may take 12-18 months before adoption.
Action Plan for Manufacturers
Immediate Actions (Next 30 Days)
- Inventory your device portfolio against the expanded WET lists in both delegated acts
- Identify devices that are currently undergoing clinical investigation planning — some may now qualify for exemption
- Notify your Notified Body if you believe your devices qualify for the expanded exemptions
Short-Term Actions (30–90 Days)
- Reassess clinical evidence strategies for qualifying devices — shift from investigation planning to literature-based CER development
- Compile existing clinical data — literature, PMS data, registries, clinical practice guidelines
- Update regulatory project timelines and budgets — clinical investigation exemption can save $50,000–$500,000+ per device
Ongoing
- Monitor the Official Journal for publication dates of both delegated acts to confirm the entry-into-force date
- Track the broader MDR simplification proposal for additional relief measures that may affect your devices
Frequently Asked Questions
Does the WET exemption mean I don't need a clinical evaluation?
No. The exemption is from clinical investigations only. You must still plan, conduct, and document a clinical evaluation in accordance with Article 61 MDR. The clinical evaluation will be based on existing clinical data rather than data generated by a new clinical investigation.
Can a device with a novel material qualify as WET?
Generally no. WET criteria require a common, stable design with little evolution. A novel material would typically disqualify a device from WET classification, even if the device type is listed in Article 61(6)(b).
Does the exemption apply to devices that are already on the market?
Yes. The exemption applies to both new and existing devices. Manufacturers of devices already CE marked under MDR can leverage the exemption for renewals, variations, and ongoing compliance.
What if my device type is listed but I don't have sufficient clinical data?
The exemption requires sufficient clinical data. If you cannot compile sufficient existing evidence, you may still need to conduct a clinical investigation despite the device type being listed as WET.
How does this interact with EUDAMED?
WET devices must still be registered in EUDAMED. The device type classification can be indicated in the device registration module. The WET status may also be relevant for Notified Body certificate entries.
Will the WET list continue to expand?
The Commission has signaled willingness to continue expanding the list. Article 61(8) provides the legal basis for further delegated acts. Manufacturers with devices that meet WET criteria but are not yet listed should engage with their trade associations and the MDCG to advocate for inclusion.
Background: Stakeholder Consultation
The expanded WET device list was developed in 2025 through a wide consultation of stakeholders with observer status in the MDCG Clinical Investigation and Evaluation Performance Studies and Evaluation Working Group, the Borderline and Classification Working Group, and Competent Authorities who are members of the MDCG itself. This consensus-based development process means the list reflects practical regulatory experience with the MDR, not theoretical device categorization.
Sources and References
- Commission Delegated Regulation C(2026) 1798 — amending MDR Article 61(6)(b)
- Commission Delegated Regulation C(2026) 1809 — amending MDR Article 52(4)
- MDCG 2020-6 — Guidance on clinical evidence needed for medical devices (WET criteria)
- Regulation (EU) 2017/745 — Medical Device Regulation, Articles 52(4), 52(5), 61(6)(b), 61(8)
- Official Journal of the European Union — publication pending at time of writing