The Medical Device Regulation (MDR) is a new regulation governing the safety of medical devices available in the European Union (EU).
Medical device manufacturers looking to export products to the EU, need to obtain CE Marking in line with the EU medical device regulations.
The new regulation introduces several sweeping changes, including tighter and more stringent requirements to ensure patient safety, as well as increased transparency and traceability along the entire supply chain.
With the medical regulatory landscape undergoing its most significant overhaul in years, there is a need to stay both up-to-date with the latest regulatory intelligence, and understand how related changes impact your organisation.
Download the ‘What is the new MDR’ datasheet to find out more on the key regulatory changes introduced in the MDR.