With the entry into force of the Medical Device Regulation (MDR) on 27.05.2021, the requirements for manufacturers and distributors of medical devices are changing. It is the logical response to the increased number of risk reports (including PIP-scandal) on medical devices in the EU in recent years. This new regulation is intended to close the gaps in the currently valid directive on medical devices and thus increase and ensure patient and operator protection.
Medical device manufacturers and distributors depend on the support of their suppliers to comply with the MDR. ODU as a supplier and specialist for connectors for medical applications has been dealing with the MDR since its publication and is confronted with a number of demands from the MDR.
Among other things, ODU operates appropriate technical documentation, adequate risk management and change management, as well as management of CMR substances to comply with this requirement. Furthermore, ODU ensures complete traceability with its systems. The topics of patient and operator protection are implemented in our products in compliance with IEC60601-1. As a further service, ODU offers its customers the application of their Unique Device Identification (UDI) by laser marking of our connectors. By consistently implementing and complying with these points, ODU will continue to be a competent partner for its medical customers in the future.
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