GERMANY—Pjur has become one of the first manufacturers of personal lubricants to be certified as a medical device manufacturer in line with the European Union’s Medical Device Regulation or MDR. The Germany-based personal lubricant maker is also planning to introduce its new branding at eroFame next month.
According to MDR regulations, Pjur personal lubricants are now 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.”
Pjur predicts that 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," the company said. "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 2022 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.
“Since the MDR came into effect in 2017, we have continuously worked to implement it in our company. Pjur recognized early on how dull yet critical this process would be and spared no effort to get MDR compliant,” said 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.”
Pjur is now incorporating the knowledge of an MDR-compliant manufacturer of class IIb medical devices into its external communication. To respond to questions from specialist retailers and customers, Pjur has now trained employees in the sales, marketing and PR, and communication teams as medical product advisors.
Medical product advisors for Pjur products will tell specialist retailers and their customers about the products and provide instructions on how to use them properly. 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,” Giebel 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, e-mail [email protected] or speak to a Pjur marketing team representative.
Meanwhile, the company is set to debut its new branding at eroFame, taking place Oct. 5-7 in Hanover, Germany. "Pjur’s new product range which already has all the elements of the brand refresh will also be presented," company materials said. Pjur's modern branding will be immediately visible at the 152m² Pjur booth.
Over the last two years, Pjur has focused on analyzing how the brand has developed in the past and is deciding on its new focus for the future. “Our brand has developed beyond recognition—and so have the international markets,” Giebel said. “It was time for us to reinforce the brand’s core and its values, and adapt the brand’s visual look and brand communication to ensure it is fit for the future. The focus is on meaning, clear values, recognition, and differentiation. This will enable us to strengthen our position on the market for our partners and the consumers.”
The new image began appearing in early September. However, visitors at eroFame will be treated to an in-person introduction.
“A new product range from Pjur… [makes] it a great example of the brand’s new direction. But it’s not just the design that makes the new product range so different from previous Pjur products. eroFame visitors will find out exactly what that means as an exclusive at the trade fair,” the company reports.
For more information about the company, please visit www.pjur.com.
