Project purpose
The effective management of logistics supply chain processes is pivotal for ensuring access to critical medical therapies, encompassing both pharmaceutical products and medical devices.
The “MDR Project” is a collaborative effort of industry stakeholders aiming to offer a better understanding of the evolving regulations and their impact on supply chain operations.
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.
Project objective(s)
The project, Balancing Innovation and Regulations: from Care to Air, 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.
The project consists of 4 Work Packages:
- Work Package 1: Mobilization of stakeholders and conduct kick-off session
- Work Package 2: Assessment and information gathering through desk research
- Work Package 3: Workshops with designated stakeholders and guideline creation
- Work Package 4: Publications (Technical Report and White Paper)
Project status and key-takeaways
Project duration: 6 months (October 2023 – March 2024)
Key takeaways:
- The new regulations have primarily affected medical device manufacturers and entities within the EU that take ownership of the devices, rather than service providers acting as subcontractors for these owners.
- Manufacturers must ensure compliance with numerous requirements and involve the right economic operators in their value chains, both within the EU and globally. Despite the medical device market being often overlooked, understanding its regulations could reveal untapped opportunities to improve the value chain.
- The project team identified several opportunities for logistics service providers to support economic operators in the medical device sector, including aiding market entry, improving returns management, and handling special (hazardous) materials.
All takeaways are elaborated in detail in the project’s Technical Report, accessible exclusively to members of the Pharma Aero community.
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