pjur receives official European MDR certificate
Back in August 2022 the pjur group successfully passed the first MDR audit and received confirmation of compliance according to the MDR Medical Device Regulation (EU) 2017/745. Now the company has received all the official documents, and pjur can confirm there are no restrictions on the marketability of its personal lubricants as class IIb medical devices
Secure future for pjur as a manufacturer of premium personal lubri cants
Receiving the MDR certificate is an important step for the company: it is now one of the first of the few personal lubricant manufacturers who have received this certification. This secures pjur’s future as a personal lubricant manufacturer, because the new MDR regulation means that in 2024 the market for personal lubricants will change dramatically. The new Medical Device Regulation (MDR), which came into force in 2017, supersedes the current Medical Device Directives (MDD) and makes the regulation of medical devices far more stringent.
According to the new regulation, personal lubricants are classified as class IIb medical devices as a minimum, as unlike cosmetics, they can be introduced into the body. The change to the transition deadline in March 2023 requires all personal lubricant manufacturers to start this certification at the latest by mid-2024, otherwise their product will no longer be a medical device, may no longer be introduced into the body and cannot be called a personal lubricant anymore.
pjur is making the MDR certificate, as a certificate of conformity according to MDR 2017/745, and the EN ISO 13485 certificate available immediately to all retailers and distributors on the pjur homepage to view and download
