The documentation of an in vitro diagnostic device is not built the same way at every risk class. Regulation (EU) 2017/746, known as the IVDR, replaced the lists of the former directive with a four class system. The class drives the volume of evidence expected, the role of the notified body and the pace of updates after CE marking. Here is what the class changes in IVD documentation, and where the gaps keep appearing.

Classify before you write

Classification follows Annex VIII, which sets out seven rules applied to the intended purpose declared by the manufacturer. Classes run from A, the lowest risk, to D, the highest. Rule 6 acts as a safety net: a device covered by none of the preceding rules is class B. Devices for self-testing are in principle class C, save for listed exceptions that remain class B, such as pregnancy and fertility tests. Near-patient testing devices are classified on their own intended purpose.

That reasoning is written down in the technical documentation. The European Commission publishes dedicated guidance, MDCG 2020-16, whose revision 4 is dated 18 March 2025, with worked examples rule by rule. Where a manufacturer and a notified body disagree, the decision falls to the competent authority of the Member State in which the manufacturer has its registered place of business (Article 47).

The documentation base common to every class

Whatever the class, four annexes structure the file.

  • Annex I: the general safety and performance requirements, addressed one by one, with a written justification for those that do not apply.
  • Annex II: the technical documentation, covering device description and specification, information supplied with the device, design and manufacturing information, benefit/risk analysis and risk management, then verification and validation.
  • Annex III: the documentation on post-market surveillance, including the plan, and post-market performance follow-up.
  • Annex XIII: performance evaluation, performance studies and their follow-up after placing on the market.

Added to that are the EU declaration of conformity (Annex IV), the unique device identifier and registration in Eudamed. A non-sterile class A device therefore also carries a complete technical documentation to keep up to date.

IVDR: what the class changes in IVD documentation

The class does not change the nature of the documents. It changes who looks at them, and how deeply.

  • Class A, non-sterile: declaration of conformity under the sole responsibility of the manufacturer, with no notified body.
  • Class A, sterile: a notified body is involved, but its review is confined to the aspects relating to establishing, securing and maintaining sterile conditions.
  • Class B: assessment of the quality management system plus technical documentation review on a sampling basis, covering at least one representative device per generic device group.
  • Class C: the same pattern with finer sampling, covering at least one representative device per category of devices.
  • Class D: the technical documentation is assessed device by device, with the additional involvement of an EU reference laboratory and batch verification.

For class D, two implementing acts frame the control. Implementing Regulation (EU) 2022/1107, applicable since 25 July 2024, sets common specifications on the performance of certain devices. Implementing Regulation (EU) 2023/2713 designated the first EU reference laboratories in four fields (hepatitis and retroviruses, herpesviruses, bacterial agents, respiratory viruses), which took up their tasks on 1 October 2024.

Performance evidence, pillar by pillar

Annex XIII organises performance evaluation around three pillars: the scientific validity of the analyte, analytical performance and clinical performance. Each is documented separately. The whole is drawn together in the performance evaluation report, which forms part of the technical documentation. A performance evaluation plan precedes the studies and sets out the claims to be demonstrated and the acceptance criteria.

The class also shows after CE marking. Manufacturers of class A and class B devices draw up a post-market surveillance report (Article 80). Manufacturers of class C and class D devices draw up a periodic safety update report, updated at least annually (Article 81), plus a summary of safety and performance intended to be made publicly available (Article 29).

Labelling and instructions for use: the most exposed area

Section 20 of Annex I sets the information supplied with the device: label, packaging and instructions for use. It is the part that moves most often, and the one where we find the most gaps.

Three points deserve a systematic check. Language: each Member State determines the official language or languages in which the information must be supplied on its territory. Format: non-paper instructions for use are allowed for devices intended exclusively for professional use, outside near-patient testing, under the conditions of Section 20.1 of Annex I, with the label stating where they can be consulted. Consistency: the intended purpose carried on the label, in the instructions for use and in the performance evaluation report must be identical. A claim that appears in the instructions for use and nowhere in the evidence is a classic gap, and it surfaces when the documents are read against each other rather than one after another. That is what a tooled cross-review changes.

Where the transition stands

Regulation (EU) 2024/1860 amended Article 110 of the IVDR and extended the transitional periods for devices placed on the market under the former Directive 98/79/EC. Placing on the market remains possible until 31 December 2027 for class D devices, until 31 December 2028 for class C, and until 31 December 2029 for class B and for sterile class A. Non-sterile class A devices do not benefit from that extension.

Those deadlines are conditional. The device must continue to comply with the directive and must not have undergone significant changes in design or intended purpose. By 26 May 2025 the manufacturer had to have a quality management system in place in accordance with Article 10(8). The manufacturer must have lodged a formal application for conformity assessment and then signed a written agreement with the notified body within the following four months. For devices self-declared under the directive that become class B or sterile class A, the application is due by 26 May 2027 and the agreement by 26 September 2027. The deadlines for classes D and C have already passed.

Since 28 May 2026, the first four Eudamed modules (actors, devices and unique device identifiers, notified bodies and certificates, market surveillance) are mandatory to use. The data declared there must match the technical documentation.

In practice

Work through the file in the order it will be read. The class and its justification. The performance evidence that supports it. The information supplied with the device. The surveillance plan. Check that the same claim is worded identically everywhere. Date and version every document. Keep a written trace of the judgement calls.

That cross-review is done by hand, and it can be tooled. We cover the IVDR class by class among the review frameworks available in EryonOne, alongside the MDR and the ANSM doctrine. Your SOPs, claims matrices and glossaries can be submitted as internal requirements and checked in the same way as the official texts. The report remains working material. The conformity decision stays with your expert.

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