The BSI Group calls the new risk classification in the IVDR a “quantum leap” for products that could have been self-certified under the old directive to products soon needing notified body certification under the new regulation. Access to notified bodies has been identified as a major bottleneck in the years to come.
IVD companies targeting the european market should therefore move swiftly and resolutly if they desire to stay in business. Compiling the Technical File could be one such task.
The EU IVDR 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 check list here:
Just like the MDR Annex I General Requirements, the IVDR Annex I counterparts are also available to Aligned Elements users as a free extension.
IVDR 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 31 page check list and are made readily available in your traceability in a matter of seconds!
Kickstarting your Technical File compilation with the IVDR Annex I General Requirements extension, available to Aligned Elements user in order to 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: IVDR (EU 2017/746) Annex I Extension