Well prepared according to the MDR regulation
The European Medical Device Regulation (EU) 2017/745 (MDR) replaces the Medical Device Directive (93/42 / EEC) and was published in May 2017. The transition period originally lasted 3 years. Because of the COVID-19 pandemic, the EU Commission extended this transition period. Therefore, the start of validity is now May 26, 2021.
Under the MDR (Medical Device Regulation, EU Regulation 2017/745), materials used for the production of medical products must be provided, amongst others, with a declaration of clearance with respect to their toxicological properties.
nora® products are free of constituents posing toxicological and carcinogenic risks as set down under EU Regulation 2017/745.
Owing to their properties, nora® materials are suitable for the processing of Class 1 medical products.
Safe & proven
The closed-cell surface structure of the EVA foam also minimises the risk of harm to health in the form of germ and bacterial colonies and facilitates complete hygienic cleaning and disinfection.
Important aspects of our EVA foam:
dermatologically tested skin compatibility “excellent”
phthalate-free and latex-free
SG pollutant tested
proven cytotoxicity under ISO 10993
For us as a German manufacturer of materials that are also used in medical products, we dealt with the requirements at an early stage. As a result we initiated everything in order to provide our clients with the greatest possible safety.
QM system according to ISO 9001:2015
These requirements for continuous quality and safety are fulfilled as a result of continuous production monitoring by an extensive QM system. This in turn is supplemented with a large number of voluntary measures. In addition, there are certifications for the greatest possible reliability for our customers. The Weinheim production site and regular quality control produce quality on a consistently high level.
Generally for us as a manufacturer of materials that are also used in medical products, certification under international standards is just as much a matter of course as adherence to the pertinent legislation, e.g. REACH – followed unquestioningly and without exception by every manufacturer in the EU.
If you have questions or need information, talk to us!