Vivak® Med are transparent sheets made of thermoplastic copolyester which meets ISO 10993/USP Class VI biocompatibility requirements. They combine impact strength with excellent thermoforming properties 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 Vivak® 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
The special Plus