Exolon® Med are transparent sheets made of polycarbonate which meets ISO 10993/USP Class VI biocompatibility requirements. They offer extreme impact strength that exeeds the physical properties of other products of their class and high-clarity.
The EU has published a new Medical Device Regulation (MDR)(1)which is a regulatory framework to ensure safety and efficacy of medical devices. The use of Exolon® Med will enable the OEM manufacturer to be compliant with the new EU MDR in terms of reliability and traceability for their rigid packaging.
(1) Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
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