New Checklist for Clinical Evaluations Available

mdi Europa has set up a checklist that is based on a formal template issued by the German competent authority. The template is used when reviewing the Technical Documentation, more specifically the clinical evaluation, of a manufacturer.

We think that this document may be a good tool for achieving compliance with the enhanced requirements as it provides insights on what aspects of a clinical evaluation competent authorities will look at.

If you are interested in further information, downloads etc.

You are welcome to have a look at our Supportive Information Section
Or read and save documents in our Download Section MDR / IVDR