From the next 4th of January 2022 enters into force a new Commission Implementing Regulation (CID) introducing electronic instructions of use (IFUs) for medical devices. With the aim to reduce the environmental burden of printed IFUs but also focusing on safety, this regulation establishes the conditions upon which medical devices can be provided in electronic form. Thus, as per its Article 3, the following devices can provide instructions for use in electronic form only:
- Implantable and active implantable medical devices and their accessories as per MDR 2017/745
- Fixed installed medical devices and their accessories as per MDR
- Medical devices and their accessories as per MDR with a built-in-system visually displaying the IFUs
Nevertheless, point 2 of this article states that these devices and accessories would need to be exclusively intended for professional users, not existing a foreseeable use by third persons. Contrary to this, software as per MDR can contain the instructions of use in electronic format instead of in paper form regardless of the above conditions [key difference with the previous Commission Regulation 207/2012].
Additionally, all above devices shall carry out a documented risk assessment by the manufacturer, as described in Article 4. This risk assessment shall provide proof that the instructions for use in electronic form maintains or even improves the level of safety provided by the same instructions in paper form. Further conditions are stated in Article 5 of the regulation.
On the other hand, Article 7 is of special importance, as it addresses the requirements for websites displaying the instructions of use, which are namely the following:
- The format must be readable with freely available software
- The webpage shall be dully protected against any unauthorized access or tampering intents
- Server downtime and display errors shall be minimal
- The webpage shall be compliant with Regulation (EU) 2016/679
- The internet address shall be stable and directly accessible
- All previous IFU versions and their date of publication shall be publicly available
Do you wish to know more about medical devices and labelling requirements? Please do not hesitate to contact us at mdlaw@obelis.net
You can find the full text of the Commission Regulation in our dedicated Library:
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