(EU)2021/2226 explained: Electronic Manuals for Medical Devices

(EU)2021/2226 explained: Electronic Manuals for Medical Devices – published on cemarking.net – May 24, 2022

Table of contents

Instructions for the use of medical devices are increasingly provided in electronic form. They replace the paper version. In order to regulate this properly, the Implementing Regulation (EU) 2021/2226 is in force as of January 2022.

(EU)2021/2226 explained: Electronic Manuals for Medical Devices
(EU)2021/2226 explained: Electronic Manuals for Medical Devices | Graphic by Ellina Goncharova from Alura Group

Why this Implementing Regulation?

Since 2012, manufacturers have had the opportunity to offer instructions for use in electronic form. The framework that these previously had to comply with, is described in the EU Regulation 207/2012. This covers the old MDD and the AIMD. However, the requirements on electronic operating manuals are being adapted to the new regulatory framework of the MDR. It will be fully effective as of May 26, 2022.

Therefore, the EU Commission has decided to repeal the previously applicable regulation entirely: (EU) 207/2012 is no longer valid from the aforementioned date (with a few exceptions).

Transfer to the New Standard: (EU)2021/2226

A large part of the provisions from the old standard are also in the new one. These have been transferred without changing anything. The new regulations partly contain exactly the same phrasing and carry only a few new features. The goal is still to prevent environmental pollution by providing electronic instructions for use. It regards certain medical devices and the aim is also to reduce costs for the medical device industry. The existing level of safety should at least be maintained.

Furthermore, there are also medical devices that fall under the transitional provision of article 120, paragraph 3 of the MDR. These may be placed on the market or put into service until 26 May 2024. They will continue to comply with the requirements under the old Regulation No. 207/2012 for two more years.

Necessity and Content of the Instructions for Use According to the MDR

The instructions for use of a medical device include all information provided by the manufacturer. That includes information for the user on the purpose and proper use of the respective device. In addition, the manual also explains any precautionary measures. The information is provided together with the medical device and is mandatory for medical devices of all risk classes. Nevertheless, the MDR also provides for an exception (which is described in Annex I, Chapter III, point 23.1 under section d).

There is a possibility for devices under classes I and IIa to dispense with instructions for use. This is only possible if safe use of the devices concerned can be ensured even without instructions for use. The content of the instructions for use is determined by section 23.4, Chapter III, of Annex I to the MDR. However, the more extensive conditions for providing instructions for use in electronic form are specified in the new Implementing Regulation 2021/2226.

Scope of Application Limited to Certain Product Groups and User Circles

The scope of the new implementing regulation includes medical devices according to the MDR. There are also exceptions to this, which are listed in Annex XVI of the MDR. These are products without a medical purpose. However, not all manufacturers are allowed to switch to an electronic manual without further ado (according to the limitative enumeration in Art. 3(3)). That possibility is only offered 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 that visually displays the instructions for use

Additional Limitation Regarding this Product Group

A further restriction applies: the aforementioned devices must be intended exclusively for use by professional users. Use by other persons is not reasonably foreseeable. “Professional users are “persons who use the medical device in the exercise of their profession as part of healthcare activity”.  The main novelty compared to the old Regulation 207/2012 is that the limitation to professional users does not (any longer) extend to medical software. Manufacturers are now also allowed to provide instructions for use in electronic rather than paper form for software that can be used by laypersons.

What is Not Included in the Scope of the New Implementing Regulation?

There are IVDs (in-vitro diagnostic devices) that fall under Regulation (EU) 2017/746. This is the standard for in vitro diagnostic medical devices (IVDR). These products do not fall within the scope of Implementing Regulation 2021/2226.

The IVDR defines a possible derogation in Annex I, Chapter III, Section 20 under section f. Manufacturers may omit the paper manual and replace it with an electronic instruction manual under one condition. That is when the IVD is intended for professional use only and is not intended for testing in the presence of patients.

Documented Risk Assessment

A manufacturer is still required to conduct a risk assessment. This must be documented and updated based on the experience gained in the period after the product has been placed on the market. For this reason, an article has been included that lists a set of minimum requirements for the risk assessment, Article 4.

Furthermore, it should include an explanation of user needs. Also, the risk assessment must include a description of what hardware and software are needed to display the electronic operating instructions.

In addition, the legal manufacturer is required to address, among other things, foreseeable medical emergencies in which information in paper form may be needed. 

Finally, the assessment calls for a protocol that users can follow if there is a (temporary) malfunction of the relevant website.

Addition to the New Risk Assessment Compared to the Old Standard

Article 4 of the new regulation added two items to the manufacturer’s assessment criteria:

  • evaluation of the compatibility of the website when displayed on different devices that can be used to display the electronic instructions for use; and
  • management of the different versions of the instructions for use.

Further Requirements for the Provision of Electronic Instructions for Use

The implementation of the risk assessment is not the only thing that manufacturers must comply with. There is also an extensive list of additional requirements. These are described in Articles 5 to 7. However, not much has changed compared to the previous standard. The requirements that were listed still apply today. They include the following aspects:

  • The manufacturer must have a system for providing the paper instructions for use to the user free of charge and no later than seven calendar days after a request by the user.
  • There is a clearly defined framework indicating how long manufacturers must keep the electronic instructions for use available to users. This is not uniform for all devices. It differs for each specific product or product group.
  • The label must clearly indicate that the product’s instructions for use are provided in electronic rather than paper form. If it requires software to use the manual, this information must be provided in a place where access to the software is provided.
  • The manufacturer must also make the electronic manual available on a website when:
    • the manufacturer does not make the electronic instructions available on an electronic storage medium that accompanies the product; and
    • if the electronic instructions for use are displayed by means of a system built into the product.

The website must comply with requirements listed in Article 7 (2) of the Implementing Regulation. If a manufacturer decides to offer both an electronic and a paper version of the user manual, the two must be identical in content.

One New Requirement In addition to the Existing Standard

This is described in Article 5(15). The manufacturer is required to put in place effective systems and procedures. Those procedures must ensure that users can be informed about adverse reactions or corrective actions after they have downloaded the electronic instructions for use from the website. This new information obligation will not only require a manufacturer to implement appropriate technical measures. Manufacturers will also have to look at this critically from the point of view of data protection legislation.

Electronic operating instructions must also be made available on the manufacturer’s website. In doing so, conditions are imposed on the language and on the availability of historical versions.

Conclusion

The new regulation is not very innovative compared to the previous standards. This is especially the case when you consider the speed of new digital developments. Medical device manufacturers are not really given the option to abandon paper user manuals altogether. These must be available at all times.

However, a pleasant change has also been made. That is the provision of the user manual in electronic form for medical software for layman’s use. This offers an advantage to manufacturers when they offer apps that must qualify as medical devices because of their intended medical purpose. Nonetheless, these apps raise the question of the extent to which they are actually medically ‘qualified’ and whether they confuse the user. But that is another (important) discussion.

Either way, an intensive analysis of the provisions of the new implementing regulation is advisable. This is not only for medical device manufacturers who have already used the option of electronic instructions for use under the previous regulatory framework.

(EU)2021/2226 explained: Electronic Manuals for Medical Devices – Sources, Links, and Downloads

Guido Seerden