NEW RELEASE Pharma.Aero Publishes In-Depth White Paper on Medical Devices Regulatory Landscape

Pharma.Aero has released the White Paper presenting the key findings of the Medical Devices Regulations (MDR) Project. This collaborative effort focused on the evolving regulations governing the medical devices sector.

Read here the White Paper of the MDR Project

The MDR Project combined a thorough examination of the medical device regulatory landscape in the EU, an impact assessment on logistics service providers, and a detailed gap analysis between MDR and Good Distribution Practices (GDP).

Results and Implications

The medical device sector within the EU is highly dynamic and competitive, with over 500,000 types of medical devices and in vitro diagnostic medical devices (IVDs), categorized based on risk, usage duration, and invasiveness. The White Paper outlines the roles and responsibilities of various economic operators, including manufacturers, importers, distributors, and authorized representatives.

Impact on Logistics Service Providers

One of the key conclusions is that logistics service providers (LSPs) are not classified as economic operators under the MDR, as they do not assume ownership of the medical devices. However, the transition from the Medical Device Directive (MDD) to the MDR has indirectly influenced LSPs, especially those already serving the pharmaceutical sector. These providers have had to update their Quality Management Systems (QMS) to meet new requirements from contracting companies, although they are not directly affected by the MDR.

Opportunities for Logistics Service Providers

The MDR Project highlights several opportunities for LSPs to support economic operators in the medical device sector:

  • Facilitating market entry
  • Managing returns
  • Handling special (hazardous) materials

A comprehensive analysis and detailed list of these opportunities are presented in the MDR Project’s Technical Report, available exclusively to Pharma.Aero members.

By investing in understanding the regulations and requirements faced by medical device companies, LSPs can enhance their value chain and unlock new business opportunities.

Special thanks to all our Pharma.Aero members and partners contributing to this project.
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