– PRACTICAL GUIDE
Well, in our previous blog on electronic-IFUs, we discussed that e-IFU requirements are not mandatory to comply with EU MDR requirements. That still stands true; however, there are some grey areas to some of the statements within EU MDR as well as Regulation (EU) 2021/2226.
In this blog, we like to share practical solutions to these grey areas, basis our experiences and understanding from how regulators and notified bodies are interpreting these requirements.
Following 23.1 of Annex I of EU MDR, manufacturers are expected to upload a replica of paper-IFU on the website. Well, you’ve got this correct for sure. But know what, the website compliance must also be followed in-line with Article 9 of Regulation (EU) 2021/2226.
This means that Regulation (EU) 2021/2226 may not apply fully if manufacturer is not fully transitioning to ONLY e-IFUs; however, it applies partially to all manufacturers unless they have completely opted from supplying IFUs.
Article 9 of Regulation (EU) 2021/2226 takes us to Article 7 of the same regulation where manufacturers are expected to demonstrate maintenance of the website so that users are able to access the contents electronically without any errors.
Here’s another requirements checklist to help you assist with mandatory clauses to fulfil overall EU MDR compliance:
While you comply with Article 9 (indirectly Article 7) requirements, you may want to consider the following requirements from Article 7 which are thought to be optional as of now:
Well, in our opinion, these compliance requirements are a lot here-and-there which can easily complicate the journey-to-compliance. We tried our best in these two-part series of blogs to simplify the matter for you. If you’re still concerned about these fairly new requirements, or are struggling to meet notified body’s expectations, we are right here!
Alceon Medtech Consulting provides consulting services to medical device and in-vitro diagnostic device companies for regulatory compliance, quality management system related services, clinical trial management, third-party audits and wide range of trainings.
Connect with us on contact@alceonconsulting.com for more details.
