The European Commission has long been discussing and proposed changes that significantly affect the regulation for medical devices in Europe. Finally, the long-awaited European Medical Device Regulation was approved by the European Parliament as of April 05th, 2017 and will be effective in May/June 2017.
The European Medical Device Regulation constitutes binding new and different requirements for pre- and post-market product life-cycle phases for all medical devices - current MDD CE marked and future MDR approved without national deviations.
The regulatory content and structure of the MDR is definitively designed to implement significant changes mostly recognizable for high-risk devices and long-term implants devices. Most notably are the stringent clinical evaluation requirements for all medical devices regardless of risk classification.
To ensure medical device design and development programs are well adapted to meet challenging new requirements in securing commercial success and return of investment, a thorough and robust regulatory strategy is a must have asset for medical device manufacturers.
This presentation focus on key success factors implementing a successful regulatory strategy as an integral part of an overall business planning process. Representative case studies will demonstrate some key techniques to avoid costly delays and competitive disadvantages.