While the EU MDR has been delayed until 26 May 2021, allowing medical device, software, and combination product manufacturers an extra year to ensure their systems comply with the regulatory requirements, the challenges created by COVID-19 has made this complex implementation even more so.
Here in this interactive eBook, MedTech Summit takes an in-depth look at how the EU MDR will affect clinical evaluations for medical devices and IVDs in numerous ways, making the regulation more stringent. Industry experts offer insights on Clinical Evaluation Reports (CERs), “sufficient clinical evidence”, Post-market clinical follow-up (PMCF) and much more.
