Manufacturers looking to launch their medical device within the European Union (EU) need to comply with the relevant EU medical device regulations. The CE marking is a legal demonstration that the manufacturer’s product has met the relevant regulatory requirements of the European Union.
The CE marking process can, at first, seem a daunting process even for the most seasoned regulatory affairs professionals, so we have simplified it into two compact guides which you can download for free.
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.