Understanding the EU Medical Device Regulation Conformity Assessment Procedures
Manufacturers looking to launch their medical device within the European Union (EU) need to comply with the relevant EU medical device regulations.
The first step in the process is for manufacturers to classify their medical device based on the requirements in the new Medical Device Regulation (MDR).
Then, based on the classification of the device, manufacturers can identify the appropriate conformity assessment route for their product. This route will determine the required activities manufacturers will need to comply with in order to receive a CE marking.
LRQA’s guide to the MDR Conformity Assessment Procedures will help you understand the different routes to compliance, and which route applies to your medical device.