Medical Devices Regulations

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 ongoing, following the steps:

Work Package 1: Host and exclusive webinar for the members of both organisations (Pharma.Aero and HLA) on June 15, 2021, followed by a survey. The results of the survey and insights gathered amongst the presenters, the attendees and the project group were outlined in a White Paper. This first report examined the competitive positioning of UAV against other transportation modes, the regulatory framework for drone operations and applications of UAV in the Pharma and Humanitarian Air Cargo sector.
Work Package 2: Create a 360° interactive video to showcase drone lab technologies, different types of drones and drone operations. This video is now available for Pharma.Aero members only.
Work Package 3: Map the journey of the Covid-19 vaccines from the manufacture point in Europe to the arm of the patient in Malawi. Draft a list of recommendations on how to optimize the end-to-end transportation by shortening the supply chain and linking both traditional airfreight and drone worlds. Disseminate a theoretical proof of concept (technical report and white paper). See here the video of the Vaccines transportation from Belgium to Malawi.