WASSERBILLIG, Luxembourg — Personal lubricant manufacturer Pjur has been certified as a medical device manufacturer under the new Medical Device Regulation (MDR) in the European Union.
To continue marketing their products as "personal lubricants," manufacturers must be certified as medical device manufacturers by May 2024, the end of the transition period. Pjur completed its first MDR audit last month, and its products are now classified as Class IIb medical devices in accordance with the rule.
"Since the MDR came into effect in 2017, we have continuously worked to implement it in our company," said Pjur CEO Alexander Geibel. "We don’t make any compromises when it comes to the quality and safety of our products. We are proud to be one of the first manufacturers of personal lubricants to go through the process to obtain MDR certification. I’d like to thank our employees, whose outstanding work made it possible for us to gain the certification."
In accordance with the new regulation, Pjur has trained several employees as "medical product advisors."
These advisors "tell specialist retailers and their customers, the users, about medical products and instruct them in how to use them properly, acting as an interface between customers and manufacturers," said a rep. "To give both business partners and customers the best possible advice, 'medical product advisors' must continually keep themselves up to date about the medical products concerned."
Geibel discussed the benefits of MDR certification.
"With the new MDR, we now not only have new obligations, but also more opportunities," he said. "Training our teams to become comprehensively trained Pjur specialist advisors guarantees that our products will be sold safely in line with the regulations. This means we will have great communication in place at eroFame, which takes place at the start of October in Hanover."
For more information, visit Pjur online and follow the company on Twitter.
