Elizma Parry - director, Global Clinical Practice at Maetrics explains what pharmaceutical manufacturers should be doing to prepare for new and important regulations surrounding medical devices.
Untangling web
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.
As such, some pharmaceutical manufacturers may have assumed exemption from the new regulations that target medical device products. They are, however, mistaken. From here on, pharmaceutical companies will undergo oversight for both the device and medicinal components of their combination products. This represents a big change, given that liaising with a national Competent Authority (CA) was the only thing required of them until recently. Indeed, the EU MDR asks that all medical devices have a CE mark in order to continue circulating on European markets. Under the new EU MDR and EU IVDR, no medical device can evade regulatory scrutiny, regardless of its size or function. Previously immune to such strict requirements, it is understandable that pharmaceutical manufacturers producing combination products or companion diagnostics may not realise the obligation they now have under the new medical device and/or in vitro diagnostic regulations for the European market.