Registration According to MDR EU 2017/45 Directive
As a producer of tear-resistant textiles, also known as Suicide Prevention Equipment, we’re excited to share a significant milestone with you: Tetcon’s tear-resistant clothing and bedding are now registered as medical devices. This means they fully comply with the MDR EU 2017/45 directive, and as a result, these products will now bear the CE and MD symbols. This opens up a range of possibilities for the medical sector, both domestically and internationally, promising enhanced protection for vulnerable patients.
Ensuring Safety: Tear-Resistant Blankets, Pillows, and Clothing
You may have noticed that Tetcon offers two tear-resistant lines: the Economy Line and the Tricot Extreme Line. The well-known tear-resistant blankets, tear-resistant pillows, and tear-resistant clothing from both lines are now recognized as effective and secure options within medical environments. So, if patients or individuals in your institution depend on these products, rest assured that they meet the highest medical standards for protection and comfort.
Why is the MDR EU 2017/45 Directive Relevant to You
The registration according to the MDR EU 2017/45 directive acts as a quality assurance stamp. It ensures that these products are developed and marketed according to the stringent ISO 13485 norm linked to the MDR directive. These rigorous standards guarantee that the tear-resistant materials meet the highest medical requirements.
No Physical Product Labels: A Wise Decision
Despite the registration, Tetcon’s tear-resistant products will not be equipped with physical product labels bearing the CE mark. This decision, made with safety in mind, prevents the risk of self-injury. Physical labels could be too easily pulled off clothing, jeopardizing the safety of the patient. However, all product packaging will display the CE mark, the MD symbol, a LOT number, and a production date. Refer to the image below for an example.
In summary, the registration of Tetcon’s tear-resistant materials as medical devices is not just a leap forward for the industry but especially for patients, clients, and detainees. Their safety, along with that of your colleagues, is our top priority.
We remain dedicated to providing the best possible protection for your organization. Are you interested in our range of tear resistant textiles? Facilities all across the globe rely on the quality of this equipment. Discover all the options here.