Kari Miller, Regulatory and Product Management Leader, Pilgrim Quality Solutions, an IQVIA company
Meeting the reporting and legal requirements of regulations, such as the EU Medical Device Regulation (MDR) and the recently mandated EU General Data Protection Regulation (GDPR), can be a daunting task. An initial review of both regulations brings forth seemingly clashing requirements. In fact, the balancing act that needs to occur within an organization to comply with both is a delicate one.
This is the first of two blogs that will look at the components of EU MDR and EU GDPR. I will address the potential impact of EU GDPR on EU MDR, with a particular focus on Complaints processing and Vigilance and Safety Reporting. In part two, I’ll outline the areas where these two EU-based regulations intersect. (more…)