The sentence comes up regularly in SMEs that manufacture Class I devices: “We are self-certified, so we do not need a clinical evaluation.” That is incorrect. Article 61 of the MDR applies to all medical devices, with no class exemption. Self-certification concerns the conformity procedure, not the obligation to carry out a clinical evaluation.
What Article 61 requires for Class I
Clinical evaluation exists for all devices. The difference from higher classes lies in the level of evidence required and the depth of the demonstration — not in the existence of the obligation.
For a low-risk Class I device, the clinical evaluation can rely essentially on a documented literature review covering the available safety and performance data for that type of device. It does not generally require conducting a prospective clinical study. But it must be documented, structured, and conclude on the device’s conformity with the applicable general safety and performance requirements (GSPR).
What is enough in practice for Class I
A documented literature review. A search of the relevant databases (PubMed at a minimum), with a reproducible search strategy. The articles retained must be relevant to the type of device, its intended purpose and its target population. Excluded articles must be excluded according to criteria defined in advance.
A critical analysis of the data identified. Not a list of articles with abstracts. An analysis that assesses the methodological quality of the data, their relevance to the device, and what they allow to be concluded about clinical safety and performance.
A conclusion on the benefit/risk ratio. The conclusion must be explicit: on the basis of the available data, the expected clinical benefits outweigh the residual risks under the intended conditions of use.
What is insufficient even for Class I
A list of articles with no analysis. A document that says “the literature data show that similar devices are safe” without citing the sources or assessing their quality. A clinical evaluation that is 10 years old and has not been updated even though new data are available.
The ANSM can request the technical documentation of a Class I device during a market surveillance campaign. If the clinical evaluation is missing or manifestly insufficient, the placing on the market can be suspended — even for a low-risk device whose intrinsic safety is beyond doubt.