Annex XVI products

If your product is now regulated under the MDR, the first step is to assess where your product and company stand in relation to the new requirements. We offer support through a detailed gap analysis, identifying where your current setup falls short and working with you to create a roadmap for compliance.

A well-defined strategy is crucial when bringing Annex XVI products to market. This strategy should outline the end goal and the steps needed to reach compliance. Our team of medical device experts can assist you in crafting a clear and actionable plan that meets all regulatory requirements.

Bringing your company and products into compliance is a complex process that requires dedicated effort. Depending on your needs, our experienced medical device team can become an integral part of your team, offering support across various roles, such as regulatory affairs (RA), quality assurance (QA), clinical evaluation, risk management, and more.

Under the MDR, clinical evaluation is the process of confirming a device's conformity with the relevant general safety and performance requirements outlined in Annex I. For Annex XVI products, demonstrating clinical benefit is interpreted as proving the performance of the device, which further complicates the clinical evaluation process. Our clinical experts are ready to provide essential insights or even conduct a complete clinical evaluation for your Annex XVI product, ensuring compliance with these stringent requirements.

Annex XVI products, although without a medical purpose, are now subject to the same rigorous clinical investigation requirements as medical devices. This means they must meet high industry standard ISO 14155. By following this standard and adopting a tailored approach for Annex XVI products, manufacturers can generate clinical data that is both sufficient in quantity and high in quality. A well-structured clinical development program is crucial for successful compliance. Our clinical experts are here to assist you in developing and implementing such a program.

The general risk management approach outlined in ISO 14971, which is commonly used for medical devices, also applies to Annex XVI products. This can be particularly challenging if you are not familiar with the standard. ISO 14971 requires building and maintaining a risk management system, applying it to all products, identifying potential hazards, mitigating risks to an acceptable level, and ensuring user safety. The Common Specifications provide a detailed list of hazards and risks that must be addressed for each category of Annex XVI products. Our medical device team is ready to assist you in navigating the complexities of risk management for your Annex XVI product, ensuring compliance and safety.