Can instructions for use be provided electronically under the EU MDR?

by | Jan 13, 2022 | Clinical Writing, IMed Consultancy | 0 comments

Medical Software

Find out more about the new eIFU Regulation…

Regulation (EU) 207/2012 already set out when electronic instructions for use (“eIFUs”) could be used for devices conforming to the EU Medical Devices Directive (Directive 93/42/EEC, “EU MDD”) AND the EU Active Implantable Medical Devices Directive (Directive 90/385/EEC, “EU AIMDD”).

However, recently published European Commission Regulation (EU) 2021/2226 provides the new requirements for when electronic instructions for use may be provided for medical devices under the EU Medical Devices Regulation (Regulation (EU) 2017/745, “EU MDR”).

 

So, what are the significant changes for electronic IFUs under the new regulation?

The biggest change is in the treatment of eIFUs for medical devices which are software. Under new Regulation (EU) 2021/2226, eIFUs may now be provided for software medical devices by means of the software itself. There is no longer a restriction that such software must be for exclusive use by professional users, as was required in the eIFU regulation for the EU MDD and AIMDD. (This exclusive professional use requirement does however remain for non-software medical devices conforming to EU MDR though).

 

When deciding whether to provide an eIFU for their software device, manufacturers must conduct a risk assessment which demonstrates that the eIFU ‘maintains or improves the level of safety obtained by providing instructions for use in paper form’ (Article 5(1)). Whilst this mirrors both the Directives’ eIFU requirement, Regulation (EU) 2021/2226 adds new aspects to consider within the risk assessment, such as:

  • Assessment of the compatibility between the website hosting the eIFU and the types of devices used to access the eIFU
  • Management of different versions of the eIFU

What else needs to be in place to implement eIFUs?

Here are the other main elements to take into account, when considering whether to implement eIFUs under the EU MDR:

  • Does your device fall within scope of the eIFU regulation? Check the Article 3 definitions.
  • Is your device implantable? If so, the eIFU regulation does not remove the requirement to provide an implant card, in accordance with Article 18 of the EU MDR
  • Does your device fall under Annex XVI of the EU MDR, devices without an intended medical purpose? If so, it is not covered by this eIFU Regulation
  • You must be able to provide the user with a free paper copy of the instructions for use upon request
  • You must indicate on the medical device label that the IFU is supplied in electronic format
  • You must provide the eIFU translated into the appropriate language(s) for all the EU Member States where your device is made available

If you need advice on how to implement eIFUs for your medical devices, we’d be happy to help. Just get in touch with IMed on 01295 724286 or via email to alison@imedconsultancy.com.

 

Kate Christopher

Kate Christopher

IMed QA/RA Consultant

Click here to learn more about our Clinical Writing Services: