When applying kinesiology tape in your practice, you want to offer your clients the best quality possible. The options to choose a tape are extensive, but the differences in quality vary considerably. It isn’t easy to distinguish premium quality tape from lesser quality tape.
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NEW Implemented MDR2020 (EU legislation)
In order to protect the European market for dubious medical products, new stricter European legislation for medical devices, written in the MDR legislation, will apply starting from 2020. All medical devices need to be registered in the European database. The new legislation sets stricter requirements for market authorization and the traceability of products. Audits will be carried out more often to ensure this. Everyone in the supply chain carries responsibility; from the manufacturer to reseller to end user. People must actively check whether the products they are selling, purchasing or applying, comply with the updated European legislation. Expectations are that many products cannot meet the new requirements and therefore will be discontinued. CureTape will soon be MDR ready to meet the highest standards in the medical industry.
Class 1 medical device registration
Kinesiology tape is a medical product (device), so is CureTape. All medical products that are sold within the European Union need to be CE marked and must be registered as class 1 medical device at the Ministry of Health, Welfare and Sport. This EU organization (Farmatec in the Netherlands) confirms this registration and audits whether a product keeps compliant with all medical class 1 requirements. This affects the correct technical documentation and information on packaging, such as lot numbers and expiry date. CureTape® is registered with the Dutch Ministry of Health, Welfare and Sport (Farmatec) and therefore meets all class 1 medical device requirements, as well as carries the CE mark. Audits are frequently done by external parties, to make sure the quality of the product and medical dossier fulfill all EU regulations. Many medical institutes such as clinics, hospitals and universities are only able to use registered medical class 1 products, which are managed under the highest medical requirements.
TÜV quality mark
The TÜV quality mark is a quality mark from TÜV Rheinland, Germany, one of the most important and internationally recognized suppliers of (technical) services for quality and safety. If a product is TÜV certified, buyers can rely on extensive audits and strict tests. CureTape® is TÜV certified and therefore carries this internationally recognized quality brand.
ISO certification
ISO refers to the International Organization for Standardization. This organization sets international quality standards. A number of ISO standards apply to kinesiology tape.
• ISO 9001 – the standard for quality management systems. Companies that meet this standard guarantee the quality of their products in the right way.
• ISO 13485 – an international standard for medical device manufacturers, such as kinesiology tape, to demonstrate that they meet the legal requirements for medical devices.
• ISO 14001 – the standard for environmental management systems. Complying companies follow an effective environmental management system.
The CureTape® factory and production facilities in South Korea, carry three ISO certificates and are annually audited and evaluated for these certificates.
