In our 8th life sciences localization blog series post, we’ll be discussing the impact of the Clinical Trials Regulation (EU) No 536/2014 on localization. The CTR marks a significant milestone in the harmonization of clinical trial procedures across the European Union. Its primary aim is to ensure a more streamlined and efficient framework for conducting clinical trials, with an enhanced emphasis on safety, transparency, and data reliability.  

The implementation of the Medical Device Regulation (MDR) EU 2017/745 marks a significant shift in the regulatory landscape for medical devices within the European Union. This comprehensive framework not only aims to ensure a higher level of patient safety but also to facilitate the free and unhindered movement of medical devices within the EU market. The transition to MDR’s new regulations, especially during localization, presents a series of volume and timing challenges that require careful navigation and strategic adaptation. 

As the fifth entry in our series, this blog post addresses the essential considerations for maintaining robust data security in digital health apps during the localization process, ensuring that user privacy is protected and regulatory compliance is met across all markets. 

In the rapidly evolving landscape of global healthcare, life sciences companies are navigating through a sea of regulatory changes that create significant challenges in their localization strategies. The introduction of new regulations has ushered in a new era of compliance, clinical evaluation, and post-market surveillance. These requirements, captured in the Medical Device Regulation (MDR, EU 2017/745), the In Vitro Diagnostic Regulation (IVDR, EU 2017/746), and the Clinical Trial Regulation (EU 536/2014) set the stage for a series of unique challenges in life sciences localization efforts. 

Our recent work has unveiled five principal themes, presenting unique challenges to both customers and Language Service Providers (LSPs) navigating the complexities of this regulatory landscape. We will be addressing these challenges in our weekly blog series.