Convergence — Where Medical Device Regulations Meet Pharma

The RWS 2022 European Medical Device Industry Report provides insight into the latest regulation modifications to Regulation (EU) 2017/745 (MDR). It examines how, although not as mature as the pharmaceutical regulatory ecosystem, the European medical device regulatory landscape is beginning to follow a similar path, and how linguistic requirements are an integral part of this complex ecosystem. 

This report covers: 

• Regulations and processes comparison between MDR and Pharma 
• Key linguistic factors that affect market prospects 
• Structural blindspots between the two regulations 
• Centralised solutions to address these new requirements and facilitate medical device manufacturers ability to continue business as usual

Contact us to explore how we can help you navigate the current and upcoming regulatory challenges by scaling up your translation and submission processes efficiently and ensuring full compliance with regulatory requirements.