The MDR: Navigating Europe’s New Standard for Medical Device Safety
The more stringent standards of Medical Device Regulation (MDR) demand a different approach to medical writing and regulatory strategy. MDR requires continuous data collection from planning to post-market clinical follow-up (PMCF) protocols, more exact equivalencies, and a complete reclassification of all current and future MedTech innovations. To prepare for success, companies must remain proactive and reshape their strategies to capture targeted, high-quality data throughout the product’s entire life cycle.
Listen to our Senior Medical Writer, Kim van Noort, on this podcast for insights on producing precise documentation and avoiding costly delays in the age of MDR.