To align with evolving advancements and ensure the enhancement of safety standards in the medical device industry, this project aims to implement the revised legal framework established by the European Union’s Medical Device Regulation (EU MDR), specifically Regulation (EU) 2017/745. This initiative focuses on facilitating the adaptations to comply with the regulations after the transitional period, with the key milestone being the full application of Regulation (EU) 2017/745 on medical devices by May 26, 2021.
Furthermore, this project acknowledges the global trend among various governmental bodies, such as the FDA and WHO, in establishing stringent regulations governing the manufacturing and distribution of medical devices. By embracing these standards and compliance requirements, the project endeavors to uphold the obligations outlined in the MDR (EU) 2017/745, specifically those concerning manufacturers, importers, and distributors, with a particular focus on distribution of medical devices.
This project is intended to engage Pharma.Aero community to:
- Understand the implications of the regulations on the logistics supply chain operations of Medical Devices.
- Confirm if the changes require any specific certifications from the logistics supply chain partners and manufacturers.
- Identify variations (if any) from the current EU GDP regulations and how they will impact existing framework.
Project status and key-takeaways
The project consists of 4 Work Packages:
- Work Package 1: Mobilization of stakeholders and conduct kick-off session (done)
- Work Package 2: Assessment and information gathering through desk research (ongoing)
- Work Package 3: Workshops with designated stakeholders and guideline creation
- Work Package 4: Publications (White Paper & Report)
Project support and collaboration
- Pharma.Aero Board liaison: GRU Airport, Zoetis
- Project leads: Expeditors, Qatar Airways
- Project manager and expert: Morgane Franck, PwC (external consultant)
- Project coordination: Sara Van Lerberghe, Pharma.Aero