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The pjur group launches certified class IIa medical devices-Blushfun
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pjur is focusing on establishing eye-catching displays in stores in 2019, underscoring its commitment to be the leading provider of premium intimate products ‘Made in Germany’. The company has remained committed to its strategy in autumn 2019 with the early certification of products as class IIa medical devices.
Quality is a top priority: Quality is an integral part of the pjur group, reflecting its position a provider of premium intimate products ‘Made in Germany’. pjur personal lubricants will therefore be classified as class IIa medical devices in future. pjur started to take the necessary steps for this early on and has been a certified manufacturer of medical devices in line with the new ISO standard 13485:2016 since June 2019, in order to meet its responsibility to customers and end users.
New directive ensures quality and safety: The aim of the new directive is, on the one hand, to guarantee the quality and safety of medical devices and, on the other, to place focus on product safety and protect users from risks. Once a manufacturer has been certified compliant with ISO standard 13485:2016, they are entitled to market their personal lubricant products as class IIa medical devices, as pjur is already doing with two of its products. The remaining personal lubricants in the portfolio will be transitioned to class IIa by May 2020.
Benefits for customers:
1. Rigorously tested and confirmed quality
2. Excellent compatibility
3. Guaranteed safety
4. Long-term guarantee that products are legal and can be sold
European Medical Device Regulation: Medical Devices Directive (MDD) 93/42/EEC was introduced in 1993 as the regulatory instrument for ensuring the safety, medical and technical performance characteristics of medical devices in the EU. This directive was replaced on 25 May 2017 by the new European Medical Device Regulation (MDR), which contains more stringent requirements for manufacturers of medical devices.
The transition period for switching to the new MDR comes to an end in May 2020:Manufacturers who are unable to produce an EU certificate of conformity (EU certificate) and who also do not have technical documentation or only have incomplete technical documentation may be prohibited from bringing devices to market by the authorities.To prevent this from happening, manufacturers must comply with the new international quality management standard for medical devices ISO 13485:2016. To this end, manufacturers must pass a conformity assessment and receive a certificate of compliance from a named body.
Why is quality so important? Personal lubricants are used on the most intimate parts of the body and inside the body. It is therefore in customers’ interests that all products are sufficiently tested and approved for their respective markets. pjur has a wealth of experience in manufacturing intimate products and is therefore committed to ensuring more transparency, more safety and compliance with high quality standards in manufacturing. - Blushfun Products Limited News
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