MDCG 2023-7: Exemptions from clinical investigations, explained
When Article 61(4)–(6) lets you rely on existing data instead of a new clinical investigation.
MDCG 2023-7 maps the four independent situations in which an implantable or class III device may avoid the MDR's default requirement for a clinical investigation. It also explains that sufficient access to equivalent-device data is always necessary, while a contract with the other manufacturer is mandatory only for the specific Article 61(5) route.
Who this applies to
This guidance applies when an implantable or class III device is being evaluated under MDR Article 61(4)–(6). Those devices start from a clear rule: a clinical investigation shall be performed unless one of four exemption cases is fully met.
For devices that are neither class III nor implantable, the need for a clinical investigation follows from the clinical-evaluation objectives and whether the existing evidence is sufficient. MDCG 2023-7 is not an exemption checklist for every device class.
The four exemption routes are separate
Do not combine the easiest condition from one case with another. The four routes are:
Route |
Core conditions |
|---|---|
Same manufacturer's modified device — Article 61(4) |
Modification of the manufacturer's marketed device; Annex XIV equivalence endorsed by the notified body; sufficient marketed-device evaluation; appropriate PMCF with post-market studies |
Legacy device — Article 61(6)(a) |
Lawfully marketed under the AIMDD/MDD; sufficient clinical data; compliance with any applicable product-specific common specification |
Listed well-established technology — Article 61(6)(b) |
Device is one of the listed sutures, staples, dental fillings, braces, crowns, screws, wedges, plates, wires, pins, clips or connectors; sufficient data; applicable common specification followed |
Another manufacturer's equivalent device — Article 61(5) |
Article 61(4) conditions plus an ongoing full-access contract and evidence that the other device's clinical evaluation complies with the MDR |
The contract requirement belongs to the Article 61(5) route. It does not automatically apply to the same-manufacturer, legacy-device or listed-technology routes.
Equivalence data and an exemption are different conclusions
Data from an equivalent device can contribute to a clinical evaluation even when it does not remove the obligation to run a clinical investigation. First establish equivalence across the technical, biological and clinical characteristics in Annex XIV; then separately test every condition of the chosen Article 61 exemption.
The device under evaluation still needs its own clinical evaluation. A marketed equivalent device's report does not replace it, and PMCF is expected to build evidence on the actual device rather than support equivalence forever.
What “sufficient access” means
The manufacturer must have enough access to the underlying data to evaluate every claimed technical, biological and clinical characteristic. Public summaries, labels and literature may be enough for some characteristics, but a similarity claim fails where decisive design, material, manufacturing or raw clinical information cannot be checked.
MDCG 2023-7 describes a hierarchy ranging from full technical-documentation access through detailed public or shared information to insufficient, assumption-based access. Record the source and access level characteristic by characteristic; do not write one blanket sentence saying that public data is sufficient.
What this means for you, practically
- Name the route. State which of the four Article 61 cases you rely on and why the other cases are irrelevant.
- Build a condition matrix. Map each legal condition to controlled evidence and a notified-body conclusion where required.
- Separate equivalence from exemption. Complete the Annex XIV equivalence assessment before deciding whether it removes the investigation requirement.
- Test data access characteristic by characteristic. Identify missing raw or proprietary data early; do not discover the gap during notified-body review.
- Plan device-specific PMCF. Define the post-market studies and milestones that will generate evidence on the device under evaluation.
This guidance works with the MDCG 2020-5 equivalence explainer and the MDCG 2020-7 PMCF plan explainer.
Related MDCG guidance
Related resources
MDCG guidance
MDCG 2020-6: Sufficient clinical evidence for legacy devices
The evidence bar your MDD-era device must clear for MDR certification, and which data sources count.
MDCG guidance
MDCG 2021-24: Classification of medical devices
How the MDR classification rules in Annex VIII apply in practice, rule by rule.
MDCG guidance
MDCG 2024-11: Qualification of in vitro diagnostic medical devices
How intended purpose and product characteristics determine whether a reagent, instrument, specimen container, kit, collection device or software is an IVD.
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