Medical Device Regulation, Annex VIII Rule 11 (classification of software) with Article 52 (conformity assessment by class)

Rule 11 of Annex VIII classifies software intended to provide information which is used to take decisions with diagnosis or therapeutic purposes as class IIa, except where such decisions have an impact that may cause death or an irreversible deterioration of a person's state of health, in which case it is class III. Where the decisions may cause a serious deterioration of a person's state of health or a surgical intervention, the software is class IIb.

Software intended to monitor physiological processes is class IIa, except that software intended for monitoring of vital physiological parameters, where the nature of variations of those parameters is such that it could result in immediate danger to the patient, is class IIb. All other software is class I. Software which drives a device or influences the use of a device falls within the same class as the device, and software independent of any other device is classified in its own right.

The Regulation defines a medical device to include software intended by the manufacturer to be used for human beings for specific medical purposes, among them the diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease. Before placing a device on the market, a manufacturer must assess its conformity under the applicable procedures in Annexes IX to XI.

The manufacturer of a class III device is subject to the conformity assessment in Annex IX, or may instead apply Annex X coupled with Annex XI. The manufacturer of a class IIb device is subject to the conformity assessment in Chapters I and III of Annex IX, including an assessment of the technical documentation of at least one representative device per generic device group (for most class IIb implantable devices, of every device), or may instead apply Annex X coupled with Annex XI.

The manufacturer of a class IIa device is subject to the conformity assessment in Chapters I and III of Annex IX, including an assessment of the technical documentation of at least one representative device for each category of devices, or may instead draw up the technical documentation in Annexes II and III coupled with a conformity assessment under Section 10 or Section 18 of Annex XI.

Under those procedures the manufacturer lodges an application for assessment of its quality management system with a notified body. The manufacturer of a class I device, other than a device placed on the market in sterile condition, with a measuring function or a reusable surgical instrument, declares conformity by issuing the EU declaration of conformity after drawing up the technical documentation set out in Annexes II and III.

Article 6(1) of the AI Act makes an AI system high-risk where the AI system is intended to be used as a safety component of a product, or is itself a product, covered by the Union harmonisation legislation listed in Annex I. The second condition is that the product, or the AI system itself as a product, is required to undergo a third-party conformity assessment under that legislation. Annex I of the AI Act lists Regulation (EU) 2017/745 among that legislation.

A device whose conformity assessment under the Directive 93/42/EEC did not require a notified body and whose declaration of conformity was drawn up before 26 May 2021, but for which the Regulation requires a notified body, may be placed on the market or put into service until 31 December 2028 if the conditions of Article 120(3c) are met. The Regulation applies from 26 May 2021, the date Regulation (EU) 2020/561 substituted in Article 123(2) for 26 May 2020.

The competent authorities of the Member States perform appropriate checks on the conformity characteristics and performance of devices. The Member States lay down the rules on penalties applicable for infringement of the Regulation, and the penalties must be effective, proportionate, and dissuasive.

On 16 December 2025 the Commission proposed a Regulation amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards simplifying and reducing the burden of the rules on medical devices and in vitro diagnostic medical devices.

Its text replaces Rule 11 with a rule that classifies as class I software intended to generate an output that confers a clinical benefit and is used for diagnosis, treatment, prevention, monitoring, prediction, prognosis, compensation or alleviation of a disease or condition, unless the output is intended for a disease or condition in a critical, serious or non-serious situation, in which cases higher classes apply.