Developed for regulatory personnel and medical manufacturers who need to reclassify their medical devices under the EU Medical Device Regulation (MDR2017/745).
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The MDR Gap Assessment for Classification of your medical device makes determining the definition and class of your device easy.
This template takes Annex VIII and breaks down the requirements for classification clause-by-clause into a simple, ready-to-edit template.
How to use the gap assessment:
Use the template and cross reference each clause of Annex VIII against the intended use of your medical device.
This is perfect for reclassifying your medical device under the MDR 2017/745.
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