Medical Device Regulation
Regulation (EU) 2017/745
In force since
26 May 2021
Replaces
MDD 93/42/EEC
Relevant for
Medical gloves, surgical masks
The Medical Device Regulation (MDR) is EU Regulation 2017/745 governing the placing on the market and surveillance of medical devices in the European internal market. It replaces the former Medical Devices Directive (MDD) and imposes significantly higher requirements on manufacturers and products.
For disposable products such as examination gloves, surgical masks and sterile instruments, different conformity assessment procedures apply depending on risk class.
Frequently Asked Questions
What changes with MDR compared to MDD?
The MDR tightens clinical evaluation, expands post-market surveillance, introduces UDI labeling and sets higher requirements for technical documentation.