pjur successfully registered as a medical devices manufacturer according to MDR

pjur is one of the first manufacturers of personal lubricants to be certified as a medical devices manufacturer in line with the MDR. According to MDR regulations, pjur personal lubricants are certified class IIb medical devices and may continue to be sold under the name ‘personal lubricant’ once the transition period ends in 2024. pjur is also training its employees to be MDR-certified ‘medical product advisors’.

A bit of background information

In May 2024 the market for personal lubricants will dramatically change. Until then, we are still in the transition period for the implementation of the new Medical Device Regulation (MDR for short). This regulation supersedes the current Medical Device Directive (MDD) and represents considerably stricter regulation of medical devices. According to the new regulation, personal lubricants are class IIb medical devices as they enter the body. By the end of the transition period in May 2024, all manufacturers of personal lubricants must have obtained this certification – otherwise they will not be able to refer to their product as a personal lubricant, and it will not be permitted to enter the body.

In August the pjur group successfully completed the first MDR audit and received confirmation of conformity in accordance with the MDR Medical Device Regulation (EU) 2017/745. This is an important step for the company, which is one of the first among the few manufacturers of personal lubricants who have received this certification. This means pjur’s future as a manufacturer of premium personal lubricants is secure.

Since the MDR came into effect in 2017, we have continuously worked to implement it in our company. pjur recognised early on how dull yet critical this process would be and spared no effort to get MDR compliant,” says Alexander Giebel, CEO & founder of the pjur group. “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.”

Retailers and distributors will also be made more accountable by the MDR. Anyone who distributes personal lubricants must check different things. This includes whether the product has a CE mark with the number of the inspecting body, a UDI code (Unique Device Identification) and information provided by the manufacturer. For many retailers and distributors, this is all very new and leads to many questions about both the products and their own obligations.

MDR certified quality in communication

pjur is now incorporating the knowledge of an MDR-compliant manufacturer of class IIb medical devices into its external communication. To respond in the best possible way to questions from specialist retailers and from cus- tomers and be able to give them excellent advice, pjur has now trained employees in the Sales, Marketing and PR and Communication teams as ‘medical product advisors’.

‘Medical product advisors’ for pjur products 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. 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.

pjur has been a certified manufacturer of medical devices since 2014 and has a quality management system in accordance with the ISO norm 13485: 2016. With the new MDR, we now not only have new obligations, but also more opportunities. 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,” says Alexander Giebel.