Medical Device Regulations (MDR): A Complete Guide for Manufacturers and Healthcare Businesses
Medical Device Regulations (MDR) are a set of rules and compliance requirements designed to ensure the safety, quality, and performance of medical devices placed on the market. These regulations protect patients, healthcare professionals, and manufacturers by establishing strict standards for design, manufacturing, testing, and post-market monitoring. With increasing technological advancements in healthcare, regulatory frameworks have become more comprehensive to ensure patient safety and product reliability. What Are Medical Device Regulations (MDR)? Medical Device Regulations (MDR) refer to legal requirements that govern the production, certification, distribution, and monitoring of medical devices. These regulations vary by country but share common objectives: Ensuring patient safety Maintaining product quality Preventing counterfeit or unsafe devices Monitoring post-market performance Enforcing transparency and traceability One of the most well-known frameworks is the ...