MDR (Regulation (EU) 2017/745)
Short definition
The MDR is Regulation (EU) 2017/745, which sets the rules for placing on the market and using medical devices in the European Union, applicable since 26 May 2021.
In plain language
It replaced the previous directives on medical devices and, being a regulation, applies directly in all Member States. It defines what a medical device is, how it is classified, what clinical and safety evidence the manufacturer must gather and how the product is followed up once it is on the market. Among other things, it strengthened the requirements for clinical evaluation, traceability (UDI) and the European database EUDAMED.
In practice, in an RVer session
RVer carries a self-declared CE marking under the MDR, as a Class I medical device.