More stringent requirements
for medical devices
The new European Medical Device Regulation (MDR) comes into force from May 2021 onwards. The new regulation contains more stringent requirements for manufacturers of medical devices. It replaces Directive MDD 93/42/EEC, which had previously been in effect since 1993. The new regulation is an international regulatory instrument that ensures the safety of medical devices and their medical and technical performance in the countries of the European Union.
Why is quality so important with personal lubricants?
Personal lubricants are used on the most intimate parts of the body and enter into the body through these areas. As such, it is in the user’s interest that all products are extensively tested and approved for use without any reservations. pjur has 25 years of experience in manufacturing intimate products and is therefore committed to ensuring more transparency, more safety and compliance with high quality standards in manufacturing.
For a personal lubricant to be marketed as a Class IIb medical device, the manufacturer must provide proof that their quality management system is certified in line with ISO standard 13485:2016.
What does the new regulation do?
The aim of the new regulation is to ensure the safety of medical devices and to protect users against risks.
- Rigorously tested and confirmed quality
- Excellent compatibility
- Guaranteed safety
Quality is a top priority
Quality is an integral part of the pjur brand, reflecting the company’s position as a provider of premium intimate products “Made in Germany”. As such, pjur personal lubricants will continue to be Class IIb medical devices in future. To meet its responsibility to customers and end users, pjur started to take the necessary steps early on and has been a certified manufacturer of medical devices in line with the new ISO standard 13485:2016 since June 2019.
What is that and how can you recognize it?
What are medical devices and what are their benefits?
Medical devices are products used for medical purposes that are intended by the manufacturer to be used for human beings. The term covers a wide range of technical medical products and processes that save lives, help heal and improve quality of life.
Why are personal lubricants medical devices? What functions and properties put them in this class?
Personal lubricants are applied to sensitive areas of the body such as the vagina, anus and penis. During use, they also usually enter the body. They are often used to compensate for a lack of moisture in these different areas of the body. To ensure that the products are compatible and safe for use, it is crucial that personal lubricants are manufactured as medical devices within the framework of a good quality management system.
What are the different classes and how are medical devices classified?
In Europe, medical devices are divided into four risk classes: I, IIa, IIb and III. The classification is based on use, duration of application, anatomical position and the resulting application risk. A key factor for classification is whether the conformity assessment can be carried out by the manufacturer or whether external parties must be involved in the assessment and for regular checks.
Following the introduction of the new MDR, personal lubricants will be classified as risk class IIb.
How can I tell if a product is a medical device? What should I look out for when choosing products?
- CE-mark and a four-digit number displayed on the product (appointed body) 1
- Marketing as a medical device 2