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.
MDR2020 (EU LEGISLATION)
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) and 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.
MDR2020 (EU LEGISLATION)
Health Canada issues two types of licences for medical devices:
- Medical Device Licence (MDL) – a licence issued to manufacturers authorizing them to import or sell their Class II, III or IV medical devices in Canada.
- Medical Device Establishment Licence (MDEL) – a licence issued to Class I manufacturers, as well as importers or distributors, of all four device classes to permit importation or distribution (sale) of a medical device in Canada.
ROCKMOUNT Medical Solutions Inc. holds an MDEL license in support of the importation and distributions of all THYSOL products into Canada. License 9232.
A Medical Device Establishment Licence (MDEL) is issued for the activities of manufacturing (class I), importing, or distributing (selling) medical devices for human use in Canada. An MDEL is issued by Health Canada’s Regulatory Operations and Enforcement Branch (ROEB), based on an attestation that the establishment meets all of Health Canada’s MDEL regulatory requirements.
During an inspection by Health Canada, MDEL holders must demonstrate to Health Canada that they meet the regulatory requirements they attested to having in place (e.g. documented procedures in place) related to the medical devices that they manufacture, import or distribute (sell) in Canada.
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 refers to the International Organization for Standardization. This organization sets international quality standards. Several 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.