By Nick O’Brien, Medrio
We’re at the cusp of a new era for medical device research regulations. Next year, the monumental new Medical Device Regulations (MDR) will take effect in the EU market – with the new In-Vitro Diagnostic Devices Regulation (IVDR) following just 2 years after. The reasons behind these stricter regulations are commendable. MDR seeks to:
- Increase standards for device quality and safety.
- Provide patients greater value and transparency.
- Take greater advantage of the technological advancements from the past 20 years.
What will be necessary to meet new MDR regulations? Data – and more of it than ever. Along with the aims of MDR come a clinical trial data management complexity that might cause some growing pains for the medical device industry.