The May 2017 release of a new MDR in the Official Journal of the European Union marked the start of a three-year transitional period within the medical devices industry. Manufacturers, suppliers, notified bodies, and national competent authorities must comply with the new regulation which was to take effect in May 2020 but has been postponed one year due to the COVID-19 virus. The changes made in the new MDR are significant and immense. This paper will take you through the key points to understand.
Basics of Regulatory Strategy
Driving development of drug products from pre-IND through marketing.
Global Regulatory Affairs
PRA’s Global Regulatory Affairs (GRA) group brings more than 20 years’ experience navigating the complex regulatory environment. We leverage our…
Navigating Global Regulatory CMC Processes During Public Health Crises
Chemistry, manufacturing, and controls (CMC) regulations are a critical part of the drug development path and the ongoing production and distribution…