“We’re Class I, so it’s simple.” That is the sentence I regularly hear in SMEs manufacturing low-risk devices. And it is a misjudgement that exposes manufacturers to market surveillance controls.
Self-certification means that the manufacturer attests itself to the conformity of its device, without validation by a third party. It does not mean the absence of obligations, the absence of a file, or the absence of risk.
What self-certification really implies
The Class I manufacturer’s responsibility is full and entire. The ANSM may at any time request the communication of the technical documentation of a Class I device — during an inspection, following a report, or within the framework of a thematic surveillance campaign. If this file does not exist or is insufficient, the manufacturer is in non-conformity. Placing on the market may be suspended.
What the Class I technical documentation must contain
Class I technical documentation meets the same structural requirements as Annex II, with a level of depth adapted to the low risk of the device.
Complete description of the device. Intended purpose, target population, indications, contraindications, principles of operation.
Demonstration of the GSPR. The GSPR/solutions correspondence table must exist, even in simplified form. Each applicable section of Annex I must be addressed.
Risk analysis. Even for a Class I device, a risk analysis in accordance with ISO 14971 is required. It may be proportionate to the low risk — less extensive than for a Class IIb device — but it must exist and be documented.
Clinical evaluation. Article 61 MDR applies to all devices, with no exception by class. For a low-risk Class I device, a documented literature review is generally sufficient. But it must exist.
Results of relevant tests. Biocompatibility if the device is in contact with the body, mechanical performance where relevant, electromagnetic compatibility if the device is active.
Label and IFU compliant with Annex I.
EU declaration of conformity in accordance with Annex IV.
The trap of “inherited Class I”
Many SMEs have been marketing Class I devices for years under Directive 93/42/EEC without ever having compiled formal technical documentation. Under MDR, this file must exist. There is no “grace period” for Class I files: a device placed on the market under MDR without technical documentation is non-compliant from day one.
The good news: for a well-established Class I device, with a track record on the market, compiling the technical documentation is often less burdensome than it appears. The most important work is to gather and formalise what already exists.