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How the European Union's MDR Will Impact Your Company's Supply Chain

Clinical data requirements tend to dominate conversations about the forthcoming EU Medical Device Regulation. To understand the impact the regulation will have on your company as a whole, you must grasp how it affects your supply chain and engage your partners in discussions about the information you need from them—and they need from you—to meet regulatory requirements, your timeline for CE Mark Approval and critical considerations for audits.

To put MDR supply chain changes into perspective, we asked Mike Wolf, Director of Solutions Delivery at Maetrics, to outline points of discussion for you and your suppliers.

How will MDR impact the orthopaedic device supply chain?

Wolf: MDR identifies distributors, importers and EU authorized representatives as Economic Operators, each with specific responsibilities regarding verification of compliance, cooperation in complaint handling and field safety corrective actions, and cooperating with manufacturers and Competent Authorities in device traceability. Manufacturers should review agreements with distributors, importers and authorized representatives to ensure that the interactions with these Economic Operators are clearly defined and agreed upon.

As manufacturers begin the task of achieving the CE Mark for their devices against the MDR, they need to have more data as evidence in support of compliance to the General Safety and Performance Requirements (GSPR). Suppliers can expect to receive requests from their manufacturer partners for additional data as the manufacturer must ensure that each applicable requirement in the General Safety and Performance Requirements (GSPR) is addressed in a comprehensive way.

For example, suppliers of certain types of materials or components that contain CMRs (carcinogenic, mutagenic or toxic to reproduction) may need to cooperate with manufacturers to collect data, perform additional testing if required to demonstrate compliance with the 0.1% by weight limit, and if necessary, discuss with the manufacturer the possibilities for a material change or a rationale for continued use of the material.

As another different example, suppliers of software or components of electrical devices employing software may need to cooperate with manufacturers to demonstrate evidence of adequate IT security measures, including protection against unauthorized access necessary to run the software as intended.

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