EU MDR Article 61(10): WET Device Exemption and Equivalence Requirements

1. Key takeaways

Under Article 61(10) of the MDR, well-established technology (WET) devices, such as sutures, staples, dental fillings, dental braces, dental crowns, screws, wedges, bone plates, wires for fixation, pins, clips and connectors, may be exempt from carrying out clinical investigations where there is demonstrable equivalence to an equivalent device already marketed and where sufficient clinical data are available. The exemption list is governed by delegated acts, and the most recent revision is Delegated Regulation (EU) 2026/1451, dated 2026-03-20.

The exemption is conditional in every part, and each condition carries its own evidentiary burden. The device must actually belong to the categories covered by the provision; the equivalence to the marketed device must be demonstrable, which means argued and evidenced rather than asserted; and the clinical data available must be sufficient for the purposes of the evaluation. None of these conditions is satisfied by the passage of time or by the familiarity of the technology alone. A manufacturer relying on the exemption must hold a complete file showing the category determination, the equivalence argument with its data sources, and the sufficiency assessment, because the notified body reviewing the clinical evaluation will examine all three layers, and the exemption only removes the obligation to run a new investigation, not the obligation to prove conformity with clinical evidence.

2. Legal basis

The exemption rests on Article 61(10) of Regulation (EU) 2017/745, adopted on 2017-04-05 and applicable since 2021-05-26, within the wider framework of Article 61(4) to (10). The boundaries of the obligation are set by delegated acts, most recently by Delegated Regulation (EU) 2026/1451 of 2026-03-20, which revises the list of exempt implantable and Class III devices. The equivalence demonstration itself must follow Annex XIV Part A, which defines how technical, biological and clinical characteristics are to be compared.

3. Expert insights

Insight one: what is exempted is the clinical investigation, not the clinical evaluation.

Article 61(10) removes the obligation to conduct new clinical investigations. The manufacturer must still complete the clinical evaluation, and must still have sufficient clinical data supporting it. Interpreting the exemption from clinical investigations as meaning that clinical evidence is not needed is the most common misreading of this provision. The practical consequence is that the documentation effort remains substantial: the clinical evaluation report must still appraise the available data, argue the benefit-risk profile and support every claim made about the device. Manufacturers who budget only for an equivalence letter, without the evaluation itself, encounter a full set of documentation findings at the notified body stage.

Insight two: the premise of the exemption is demonstrable equivalence, not industry custom.

Invoking the exemption requires proof of equivalence with an equivalent device already marketed across the technical characteristics, biological characteristics and clinical characteristics, and requires lawful access to the other device’s data. Most failed cases stall at the point of being unable to obtain the complete technical data of the equivalent device, rather than at the legal requirements themselves. This is a practical, not a doctrinal, problem: the data needed for a three-dimensional equivalence argument typically belong to a competitor, and access depends on contracts, confidentiality agreements or published literature of sufficient completeness. Equivalence strategies must therefore be tested for data feasibility at project initiation, before the pathway decision is committed in the project plan.

Insight three: the exemption list is adjusted dynamically through delegated acts.

Delegated Regulation (EU) 2026/1451, dated 2026-03-20, revised the list of implantable devices and Class III devices exempt from the clinical investigation obligation. Delegated acts belong to the detail level and are revised more frequently than the regulation itself, so the current version must be checked before a project is initiated. The list determines whether a whole category of products carries the investigation obligation, and its revisions can move devices in both directions. Because project plans and budgets are typically fixed months before the notified body submission, a missed revision of the list can invalidate the clinical strategy silently, so the delegated acts affecting the product category should be monitored as part of the regulatory watch routine.

Insight four: the WET list is referenced repeatedly in other provisions and operates in more than one place.

The same device names, sutures, staples, dental fillings, dental braces, dental crowns, screws, wedges, bone plates, wires for fixation, pins, clips and connectors, appear simultaneously in Article 56 (technical documentation assessment), in Article 120(3a)(a) (transitional tiers) and in Article 61(10) (clinical investigation exemption). This means a Class IIb implantable suture is treated differently from other Class IIb implantable devices on all three provisions: its transitional deadline falls on 2028-12-31 rather than 2027-12-31. Manufacturers of these devices must therefore check three separate provisions when planning, since a determination made under one article does not answer the questions posed by the other two.

4. Practical recommendations

1. Determine whether the product belongs to the WET list scope, and check in the same exercise the effects under Article 56, Article 61(10) and Article 120(3a), since the same categories appear in all three.
2. Build the equivalence demonstration as a standalone document across the technical, biological and clinical dimensions, stating the data sources and the legality of their acquisition.
3. Check the current list of (EU) 2026/1451 rather than judging from older versions, and record the version used in the project file.
4. Where the equivalent device data cannot be obtained, start the clinical investigation early instead of leaving the project blocked on the equivalence argument.
5. Complete the clinical evaluation report in full and give an explicit benefit-risk conclusion, since the exemption removes the investigation only, never the evaluation.

5. Verification checklist

• □ Whether the product belongs to the WET list scope has been determined
• □ The effects under Article 56, Article 61(10) and Article 120(3a) have been checked together
• □ The equivalence demonstration covers the technical, biological and clinical dimensions
• □ The data sources of the equivalent device and the legality of acquisition are documented
• □ The current list of (EU) 2026/1451 (2026-03-20) has been checked
• □ The clinical evaluation report has been completed in full

GRZAN supports manufacturers, authorised representatives and importers across the EU MDR market with CE marking pathway selection and classification strategy, including WET determinations under Article 61(10), three-dimensional equivalence demonstrations and delegated act monitoring. For a practical estimate of evidence timelines and documentation effort for your portfolio, contact GRZAN at info@grzanglobal.com.

Regulatory information verified as of 2026-10-29.