Postponement of the MDR
The Medical Device Regulation (EU) 2017/745 (or MDR) aims to bring unprecedented transparency for medical devices by putting the responsibilities of all market participants in focus, whereas before the Medical Device Directive 93/42/EEC (or MDD) had placed the focus mainly on manufacturers.
On March 20th 2023 an Amendment to the Medical Device Regulation to extend the MDR’s transition period has been published. This deadline extension is meant to give notified bodies more time to complete all the necessary conformity assessments and help avoid any potential shortages in the supply of medical devices. In effect, this means that the new date by which our sempermed® surgical gloves and our sempercare® sterile examination gloves need to conform to the MDR is now December 31st 2028.
Our sempercare® non-sterile examination gloves and semperguard® personal protective gloves already conform to the MDR. However, we are of course already in the conformity process with our notified bodies for sterile surgical and examination gloves and are working closely with them to ensure conformity of our gloves to the MDR requirements, as soon as possible.