MDR & Implementing Regulation (EU) 2021/2226
On 14 December 2021, the European Commission published Implementing Regulation (EU) 2021/2226. Since the entry into force of this regulation, on 3 January 2022, it is possible for manufacturers of medical devices to provide electronic instructions for use only. In this article, Certification Company discusses the most important conditions under which this is allowed.
EU 2021/2226 and Electronic instructions for use
In the regulation, ‘instructions for in electronic form’ means:!“operating instructions displayed by the device in electronic form, stored on portable electronic storage media supplied together with the device by the manufacturer or made available through software or a website.”
Professional users according to EU 2021/2226
Manufacturers may only provide electronic instructions for use for use for medical devices which:
- are intended exclusively for use by professional users (persons using the medical device in the course of their work as part of professional healthcare), and
- whose use by other persons is not reasonably foreseeable.
The option to provide electronic instructions for use for use also applies to the following devices:
- implantable and active implantable medical devices and accessories thereof that fall under the MDR (Regulation (EU) 2017/745);
- fixed installed medical devices and their accessories covered by the MDR;
- medical devices and their accessories that fall under the MDR and have a built-in system that visually displays the operating instructions for use.
For software covered by the MDR, manufacturers may provide operating instructions in electronic form through the software itself.
Before manufacturers decide to offer only electronic instructions for use, they must carry out a documented risk assessment pursuant to Article 4 of the Regulation. This risk assessment covers, among other things, the knowledge and experience of the intended user, safety aspects and (emergency) situations in which operating instructions should also be available in paper form. The risk assessment must also demonstrate that the level of safety provided by electronic instructions for use is equal to or better than that provided by paper operating instructions for use.
Other conditions of EU 2021/2226
Articles 6, 7 and 8 of the Regulation list the other conditions for the provision of electronic instructions for use for use. These conditions include:
- the availability of paper operating instructions for use and/or of operating instructions on the website;
- the time limits within which a requested paper instructions must be provided;
- corrections and amendments to the operating instructions, the manner of their notification to users and versioning;
- the retention period of the electronic instructions for use;
- the member states and languages in which the operating instructions must be available;
- information provision;
- contact information.
Would you like to read more? The full Implementing Regulation (EU) 2021/2226 can be found here. The general requirements for operating instructions of medical devices can be found in Chapter 3 of Appendix I of the MDR. Feel free to contact our experts for any assistance.