When manufacturers of medical devices wish to place their products on the market, they must, with a few exceptions, enclose instructions for use with their products that inform the user about the intended purpose and correct use of the product, as well as any precautions to be taken (see Article 2 para. 14 Regulation (EU) 2017/745 (Medical Device Regulation – ‘MDR’)). Detailed rules on the requirements to be met by the instructions for use can be found in Annex I, Chapter III, Section 23 MDR. These rules are now supplemented by Implementing Regulation (EU) 2021/2226, which has been in force since January 2022 and which replaces Regulation (EU) 207/2012 that was valid until then.
The new regulation specifies the circumstances under which instructions for use for medical devices can no longer be provided only in paper form, but also electronically. According to recital 1, the aim of Regulation 2021/2226 is to avoid environmental pollution and to reduce costs for the medical device industry, while maintaining or even increasing the level of safety.
However, the goals pursued by the EU with Regulation 2021/2226 are likely to have only a moderate impact in practice, as the scope of the Regulation is very limited in terms of both the type of products and the users of the products, and only allows electronic instructions for use in particular cases.
Limited scope of Regulation 2021/2226
The scope of Regulation 2021/2226 is limited in scope. This is due to the fact that the Regulation only permits the provision of electronic instructions for use for specific product groups and users for whom these products are intended. Article 3 Sec. 1 of Regulation 2021/2226 stipulates that manufacturers are only permitted to provide electronic instructions for use for
- implantable and active implantable medical devices and their accessories covered by the MDR,
- fixed installed medical devices and their accessories covered by the MDR (Regulation 2021/2226 contains a specific definition of a “fixed installed medical device”) and
- medical devices and their accessories covered by the MDR that are fitted with a built-in system visually displaying the instructions for use.
According to the wording of Article 3 Sec. 1 Regulation 2021/2226, any in vitro diagnostic medical device according to Regulation (EU) 2017/746 (‘IVDR’) is not covered by the scope of the Regulation. Furthermore, the products listed in Annex XVI MDR (products without an intended medical purpose) are also excluded from the scope of the regulation, cf. Art. 1 Regulation 2021/2226. A further restriction arises from Art. 3 Sec. 2 Regulation 2021/2226, which only permits electronic instructions for use for the products listed above if these products are intended exclusively for use by professional users. Professional users are defined in Art. 2 Sec. 2 Regulation 2021/2226 as persons using the medical device in the course of their work in the framework of a professional healthcare activity.
Special provisions for software as a medical device
Furthermore, special provisions do apply with regard to software as a medical device. Article 3 Sec. 3 Regulation 2021/2226 stipulates that manufacturers of software covered by the MDR may provide electronic instructions for use via the software itself rather than in paper form. This section of Article 3 was not included in the previous version of the regulation, Regulation 207/2012, and is likely to increase practical relevance of Regulation 2021/2226. This is because, unlike the other product groups, Article Sec. 3 Regulation 2021/2226 does not contain any restriction on professional users, so that software may be provided with electronic instructions for use even if the software is intended for use by consumers.
Requirements regarding the use of electronic instructions for use
If a manufacturer's product falls within the scope of Regulation 2021/2226 as described above, there are, however, various regulatory requirements that must be observed in order to provide the product with electronic instructions for use. The most important requirements are as follows:
- According to Article 4 Sec. 1 Regulation 2021/2226, a documented risk assessment must be carried out. Users may only be provided with electronic instructions for use if the risk assessment shows that the safety level is just as high as if the instructions for use were provided on paper (Article 5 Sec. 1 Regulation 2021/2226). The risk assessment includes, among other things, an evaluation of the level of knowledge and experience of the user target groups, the characteristics of the environment in which the product is to be used, safety and security mechanisms in the event of a hardware or software error and foreseeable medical emergency situations in which paper-based information is required.
- According to Art. 5 Sec. 3, the manufacturer must have a system in place that allows the instructions for use to be provided to the user free of charge and in paper form at the latest within seven calendar days of the user's request.
- According to Art. 5 Sec. 5, the manufacturer must ensure that the electronic instructions for use are correctly designed and work properly, whereby tests and validations must be provided in this regard.
- According to Art. 5 Sec. 11, the instructions for use are to be made available on the manufacturer's website in an official language of the Union, which is determined by the member state in which the product is made available to the user or patient.
Conclusion
Regulation 2021/2226 addresses issues of technical progress and allows manufacturers to provide their medical devices with electronic instructions for use. However, due to the limited scope of Regulation 2021/2226, its practical relevance is likely to be moderate. On a positive note, Regulation 2021/2226, in contrast to the previously applicable Regulation 207/2012, now also includes software in its scope of application, in particular also software intended for use by consumers, which should increase the practical relevance of the regulation. However, this increasing practical relevance is likely to become more noticeable only in the next few years, as the previously applicable Regulation 207/2012 will continue to apply until 26 May 2024 for products placed on the market or put into service in accordance with the transitional provisions of Article 120 Sec. 3 MDR (Art. 10 of Regulation 2021/2226), and software used by consumers was not covered by the previous regulation.
