Abstract

A REVIEW OF THE NEW EUROPEAN MEDICAL DEVICE REGULATIONS

Zubariya Siddiqui, *Vikesh Kumar Shukla and Navneet Sharma

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Abstract

On May 26th, 2021, the new European medical device regulation has come into force. The three existing MDDs (93/42/EEC, 98/79/EC, and 90/385/EEC) have been replaced with the newest European regulations on medical devices (2017/745) and in vitro diagnostic (IVD) medical devices (2017/746). With the implementation of Medical Device Regulation, MDR gives the reclassification rules for medical devices. To increase market traceability and transparency, the EU has implemented a unique device identification (UDI) system and a European database (EUDAMED). Throughout the device's life cycle, the post-market surveillance paperwork is required to be updated following MDR. The new MDR will have multiple impacts, one of which is that it will slow down innovation in the medical device sector. Since the new MDR requires significantly tighter clinical data and a continuous process of clinical review, the development and introduction of new medical devices to the market might become more difficult and expensive as a result of the increased regulations. The objective of this review is to give a description of some of the key features of the new EU Medical Device Regulation and to demonstrate how they will impact manufacturers, innovators, and healthcare professionals.

Keywords: Unique Device Identifier; Innovation; EUDAMED; Clinical evaluation; Medical Device Software.