Kickstart your Technical File with the EU MDR General Requirements
It's quite a chunk of text and if you have not yet started to update your Quality Management System, SOP:s and Technical Files, you should (seriously!) take some to to plan these actions accordingly.
The EU MDR Annex I General Safety and Performance Requirements section corresponds to the Essential Requirements section in MDD Annex I.
If you want to check how your current Technical Files complies with these Requirements, you can download our checklist here:
The MDR Annex I General Requirements are also available to Aligned Elements users as a free extension. This means that the MDR Annex I Requirements can be imported as Design Control into any of your Aligned Elements projects and included in the traceability. The extension corresponds to the requirements in the 37 page check list and are made readily available in your traceability in a matter of seconds!
The MDR Annex I General Requirements extension is yet another of the many available free extensions available to Aligned Elements user which helps them accelerate their medical device Design Control documentation effort. Browse through the available extensions and discover how they could accelerate your project.
The extension is available here: MDR (EU 2017/745) Annex I Extension