“The MDR requires manufacturers to submit significantly more documentation covering the total product lifecycle than previously under the MDD. A critical change with MDR is the clinical evidence necessary to demonstrate the safety and efficacy of the device… Manufacturers must be aware of how their product is now regulated to fully understand the level of clinical information required for their device and whether clinical testing is required,” explains Jordan Elder, Director of Regulatory Affairs at Regulatory Compliance Associates, in an article published in Orthopedic Design & Technology.
This article discusses what considerations medical device manufacturers should consider when looking at the revised deadlines for devices they’d like to keep on the EU market.
