New regulation on electronic instructions for use of Medical Devices
Commission IMPLEMENTING REGULATION (EU) 2021/2226 laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards electronic instructions for use of medical devices was issued in Brussels last 14 December 2021. Regulation (EU) No. 207/2012 on electronic instructions for use of medical devices is repealed with the release of this new Regulation.
This regulation and its eleven articles will lay down the legal framework for delivering electronic instructions for use.
In the provisions set out in the first part of this Regulation, to be noted are those that take into account the reduction of environmental burden and the costs of medical devices, while maintaining or even improving safety level.
To deliver instructions for use in electronic instead of paper format, the regulation, in its Article 3, makes clear which medical devices can be used, and literally reads:
- Implantable and active implantable medical devices, as well as their accessories, set out in Regulation (EU) 2017/745;
- Fixed installed medical devices and their accessories set out in Regulation (EU) 2017/745;
- Medical devices and their accessories set out in Regulation (EU) 2017/745 and fitted with an integrated system that displays visually the instructions for use.
These medical devices and their accessories must be used by professionals only.
In addition to the provisions of Article 3, this new Regulation sets outs that, for delivering electronic instructions for use, the risk associated with delivering them in this format must be first evaluated, and it must be documented. To evaluate this risk, the minimum points to be considered in the evaluation are indicated.
Once the risk is evaluated and documented, the electronic instructions for use should meet a number of requirements, and the manufacturer should have a system to provide instructions for use in paper, at no additional cost, and within no more than 7 calendar days, after receiving a request from the user.
There are other manufacturer’s requirements, such as “they should ensure the adequate design and operation of the instructions for use in electronic format and for that purpose they will provide proof of verification and validation” or “they should provide, in their catalogue or in another adequate information support, the requirements of computer machines or software required to view the instructions for use”.
Finally, a new labelling requirement is laid down for delivery of the electronic instructions for use, and the Regulation also specifies that a document should be provided, in paper if possible, that indicates how to access the electronic instructions for use, and should provide the product identifier or basic product identifier, the manufacturer’s contact data and where and how to ask for the instructions for use in paper.
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