The European Union has agreed on a new Medical Device Regulation meant to improve patient safety and data transparency. The regulation is extensive and impactful – it touches many functions within the company and companies that fail to comply will not be allowed to sell products into the EU. With the legislation expected to publish in 2017, companies will have three years to bring medical devices into compliance and, under a separate new regulation for IVD’s, five years for these products.
With the EU finally reaching the agreement, the compliance clock is ticking. Although many functions are impacted, regulatory leaders will most likely be responsible for driving corporate compliance. If you’re just starting the process, download Executive Briefing: EU Medical Device Regulation to learn five ways EU MDR will impact your business.
About the Author
Patrice Napoda is a former Director of International Regulatory Affairs for Johnson & Johnson’s Ethicon franchise, current YourEncore expert, and frequent speaker on EU MDR readiness. For the past two years, Patrice has helped Fortune 500 medical device companies assess their compliance risk and prepare for the final EU Medical Device Regulation.