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Untangling the web of pharma regulation

Some pharmaceutical manufacturers are simply unaware of their entanglement within the EU Medical Device Regulation (MDR) or EU In Vitro Diagnostic Regulation (IVDR) web. Yet, businesses manufacturing combination products or companion diagnostics will inevitably be affected by the new regulations that are coming into effect in May 2020 and 2022 respectively. With little time on their hands, it is vital that pharmaceutical manufacturers commence the preparatory steps towards compliance now.

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