As of January 2022, the provision of instructions for use for medical devices in electronic form instead of in paper form is governed by the new Implementing Regulation (EU) 2021/2226 of December 14, 2021.
Background to the new Implementing Regulation
Before the Medical Devices Regulation 2017/745 (“MDR”) came into force, the regulatory framework applicable to the manufacture and distribution of medical devices was determined by the two Directives 93/42/EEC of June 14, 1993 (on medical devices) and 90/385/EEC of June 20, 1990 (on active implantable medical devices). The opportunity to provide instructions for use in electronic form was already granted to legal manufacturers of medical devices under the aforementioned Directives by the EU-wide harmonized Regulation (EU) 207/2012 of March 9, 2012.
In order to ensure that the provisions regarding electronic instructions for use are adapted to the new regulatory framework of the MDR, which became fully applicable on May 26, 2021, the EU Commission decided to repeal the previously applicable Regulation 207/2012 and to transfer its provisions in broad parts to the new Implementing Regulation 2021/2226, with partly exactly the same wording and only a few novelties. Like the preceding Regulation from 2012, the new Implementing Regulation aims to avoid environmental pollution by providing electronic instructions for use for certain medical devices and to reduce costs for the medical device industry, whilst at the same time maintaining or raising the existing level of safety.
For medical devices that may be placed on the market or put into service under the provisions of the two Directives on medical devices under the transitional provision of Article 120(3) MDR until May 26, 2024, the requirements of the former Regulation 207/2012 will still have to be observed.
Necessity and content of instructions for use according to the MDR
The instructions for use of a medical device comprise all the information provided by the manufacturer in which the user is informed about the intended purpose and correct use of the respective device and about any precautionary measures to be taken. It is provided together with the medical device and is obligatory for medical devices of all risk classes. Only by way of exception does the MDR, in its Section 23.1 lit. d in Chapter III of Annex I, provide the option of dispensing with instructions for use for devices in Classes I and IIa if the safe use of the respective devices can also be ensured without instructions for use.
While the content of the instructions for use is to be determined decisively by Section 23.4, Chapter III of Annex I to the MDR, the modalities of providing instructions for use in electronic form are specified in more detail in the new Implementing Regulation 2021/2226.
Scope of application limited to certain product groups and circle of users only
The scope of the new Implementing Regulation covers medical devices according to the MDR, with the exception of the products without medical purpose listed in Annex XVI to the MDR. However, according to the conclusive enumeration in Art. 3 (3), the option of switching to electronic instructions for use is only given to manufacturers of the following product groups:
- implantable and active implantable medical devices and accessories
- fixed installed medical devices and accessories
- medical devices and their accessories fitted with a built-in system visually displaying the instructions for use
A further restriction can be found with regard to the target group: the aforementioned devices must be intended exclusively for use by professional users and use by other persons is not reasonably foreseeable. According to Art. 2(2) of the Implementing Regulation, "professional users" means persons using the medical device in the course of their work in the framework of a professional healthcare activity.
The main novelty compared to the previously applicable Regulation 207/2012 is that the above-mentioned restriction to professional users does not (any longer) extend to medical software. Thus, according to Art. 3(3) of the Implementing Regulation, manufacturers may provide instructions for use in electronic form instead of in paper form for software that can be used by laypersons by means of the software itself.
Not covered by the scope of the new Implementing Regulation, however, are in vitro diagnostic devices (IVDs), which are subject to the forthcoming Regulation (EU) 2017/746 of in vitro diagnostic medical devices (“IVDR”). In the context of the provision of instructions for use for IVDs, the IVDR stipulates in its Annex I, Chapter III, Section 20 lit. f that manufacturers may deviate from the instructions for use in paper form if the IVD is intended for professional use only and is not intended for near-patient testing.
Documented risk assessment as the basis for safe use
Before making the electronic instructions for use available, the manufacturer is still obliged to carry out a risk assessment, which must be documented and updated on the basis of the experience gained in the period after market launch. For this purpose, the Implementing Regulation specifies in its Art. 4 a catalogue of minimum requirements for the risk assessment: In addition to the assessment of the level of knowledge and experience of the target user groups with regard to the use of the product, the user needs, the hardware and software required to display the electronic instructions for use, the legal manufacturer is also obligated, inter alia, to address foreseeable medical emergency situations in which information in paper form might be required, as well as the effects of a temporary failure of the respective website and possible safety measures to deal with such a situation.
A novelty compared to the previously applicable risk assessment requirements can be found in Art. 4(1)(j) and (k) of the Implementing Regulation, which add the following points to the assessment criteria imposed on the manufacturer:
- evaluation of the compatibility of the website in displaying the electronic instructions for use on various devices that could be used to display these instructions for use; and
- management of the different versions of the instruction for use.
Further requirements for the provision of electronic instructions for use
In addition to performing the risk analysis, manufacturers must comply with an extensive catalogue of additional requirements set forth in Articles 5 to 7 of the Implementing Regulation. These basically reflect the terms already applicable under the former Regulation 207/2012 and cover, among others, the following aspects:
- The manufacturer shall have a system in place to provide the paper instructions for use to the user free of charge and no later than within seven calendar days of requests by the user.
- For devices with a specific expiration date (except implantable devices), manufacturers are now required to keep the electronic instructions for use available to users for ten years after the last device was placed on the market, and at least two years after the expiration date of the last device manufactured. For devices without a specific expiration date and for implantable devices, the previously applicable period of fifteen years for keeping the electronic instructions for use available remains in effect, but the expiration date is now determined by the time the respective device is placed on the market (the period previously began with the manufacture of the last device).
- The manufacturer is also obliged to clearly indicate on the product labelling that the product's instructions for use are provided in electronic form instead of in paper form. In case of software, this information shall be provided at a place where access to the software is granted.
In the event that the manufacturer does not make the electronic instructions for use available on an electronic storage medium supplied in addition to the product, or if the electronic instructions for use are displayed by means of a system built into the product, the electronic instructions for use must also be made available to users on a website which must meet the requirements specified in Article 7(2) of the Implementing Regulation. If the manufacturer decides to provide electronic instructions for use in addition to the complete instructions for use in paper form, the electronic and paper forms must be identical in content.
A new requirement that manufacturers will have to fulfil from now on is the obligation laid down in Art. 5(15) of the Implementing Regulation to implement effective systems and procedures to ensure that users can be informed of updates or corrective measures relating to the products after downloading the electronic instructions for use from the website. In this context, the question of implementing appropriate technical measures to comply with this new obligation to inform will not be the only practical issue. Manufacturers will also have to critically examine the measures foreseen for this purpose from a data protection law perspective.
If the manufacturer provides electronic instructions for use for its products, these must also be made available on the manufacturer's website. The language in which they are to be published depends on the national structure of the Member State in which the product in question is made available to the user, cf. Art. 5(11) of the Implementing Regulation. In addition, all published historical electronic versions of the instructions for use must be made available on the website.
In light of the ongoing digitalization also in the healthcare sector, the innovations of the Implementing Regulation 2021/2226 are marginal compared to the previously applicable provisions, and in particular do not grant medical device manufacturers the option of completely dispensing with the instructions for use in paper form. These must be made available at all times as a "back-up" solution and at the request of users.
Only the provision of the instructions for use in electronic form for medical software for the purpose of use by laypersons is a welcome correction by the Commission and will, among other things, bring relief for legal manufacturers when providing apps that are to be qualified as medical devices due to their intended medical purpose.
But an intensive analysis of the provisions of the new Implementing Regulation is not only advisable for medical device manufacturers who have already made use of the option of electronic instructions for use under the previous regulatory framework. Implementation of the new requirements is also worthwhile if products from the product portfolio are equipped with comprehensive instructions for use on the one hand, and are also sold in countries outside the EU on the other, where the provision of instructions for use in electronic form is also permitted by the applicable legal framework.