Stronger together: The regulatory bond between suppliers and manufacturers

Evolving regulations are forging a closer relationship between plastics suppliers and medtech manufacturers says Adam Price, director of product, Rimsys.

Manufacturers of medical-grade plastics continue to play a critical role supplying high-grade materials to the medtech industry for medical and drug delivery devices, their components and diagnostics. Medtech manufacturers rely on purchasing controls within their quality management system to identify, assess, classify, and apply appropriate controls to each supplier partner. As the industry works to accommodate evolving standards, regulations, and certification processes and manufacturers adjust quality management systems as a result, partners within the supply chain are often affected by these changes. Medtech manufacturers must take steps to identify and best equip businesses playing the role of a critical supplier to be prepared to respond to changing requirements; they must also acknowledge the role critical supplier partners play in maintaining Notified Body (NB) certifications, and take action to ensure audit success.

Regulatory Authorities responsible for ensuring the safety and efficacy of medical devices in the market are increasingly reliant on NBs — independent, non-governmental organisations accredited to evaluate devices and medtech manufacturers’ quality management systems for conformance to applicable standards and regulations. NBs play a key role conducting certification and surveillance audits to establish this conformance and are especially prevalent in the application of the new European Medical Device Regulation (MDR), In Vitro Diagnostic Regulation (IVDR), and corresponding CE certification for sale of devices into the European Union (EU).

NB jurisdiction had been largely limited to legal manufacturers of the sellable medical devices with the responsibility to demonstrate purchasing controls lying solely within that manufacturer’s quality system. As Regulatory Authorities continue to expand the usage of NBs under MDR and IVDR to assess the medtech industry, these organisations have undertaken expanded roles and corresponding increased scope of responsibility. As a component of this new responsibility, an NB now expects audit access to all critical suppliers and to all sites where devices or critical materials and components are produced. Medtech manufacturers must identify and understand this exposure to ensure critical supplier partners are prepared and capable to manage an NB inspection should that need arise. It’s important to note that NBs may notify medtech manufacturers and their critical suppliers of an upcoming audit, but are within their power to arrive onsite unannounced for an audit. Regulatory Authorities require NBs to conduct unannounced inspections at some frequency as part of the certification process.

Medtech manufacturers placing devices into the EU should determine critical suppliers in partnership with their NB. The contracts put in place between the manufacturer and the critical supplier should clearly acknowledge this role when appropriate and anticipate the need for both announced and unannounced NB inspections at the manufacturer as well as critical supplier facilities. Although there is no requirement for manufacturers to notify supply chain partners of their status as a critical supplier, the communication of this role and ensuring that critical suppliers have sound understanding of how to best support an onsite NB audit are key. The support is especially important in guiding those critical suppliers who have minimal experience managing an audit of this fashion.

Communication and awareness are the first steps in aligning for this partnership, along with shared regulatory insight and information. Medtech manufacturers should consider shared access to regulatory information management or other systems where product and manufacturing information is consolidated. They can provide this access to critical suppliers to develop the capabilities and confidence to manage NB audits on their behalf.

Medtech manufacturers can plan for success by opening lines of communication with supply chain partners identified as critical suppliers. With an aligned understanding of this relationship and appropriate preparation, partners can be prepared and confident in their capability as a critical supplier to the medtech industry.