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European Union: EU-MDR

The new European Union Medical Device Regulation (MDR 2017/745) brings significant changes to previous regulations. The EU adopted the new Medical Device Regulation, replacing the two existing directives, the Medical Devices Directive (MDD) and the Active Implantable Medical Devices Directive. Device manufacturers who market products in the EU must be ready to meet the May 26, 2021 transition deadline (delayed from 2020 due to the coronavirus pandemic). OMC Medical assists manufacturers to build a structured and well-managed approach to meet the new EU Medical Device Regulation objective depending on the product portfolio.

EU-MDR Key changes:

EU-MDR Key changes: