REGULATORY AFFAIRS SUPPORT
We support our customers with regulatory affairs questions related to antimicrobial materials and their intended applications.
We understand that antimicrobial functionality is not only a technical topic, but also a regulatory one. Depending on the material, application, market, and claim, different requirements may apply. This is why early regulatory assessment is an important part of a successful development process.
Our team helps customers understand which regulatory aspects may be relevant for their product, including material documentation, antimicrobial claims, test requirements, biocompatibility considerations, and the distinction between product protection and user protection claims.
We support our customers in preparing the technical basis needed for regulatory discussions, customer documentation, and validation planning. This may include selecting appropriate test strategies, aligning laboratory results with intended claims, and identifying the documentation required for further product development.
Not automatically. Two separate questions decide it.
Under MDR Annex VIII, Rule 14 covers devices incorporating, as an integral part, a substance that would be a medicinal product if used separately, and whose action is ancillary to that of the device. Where Rule 14 applies, the device is Class III.
The first question is therefore whether the antimicrobial substance would meet the medicinal product definition on its own. Many additives do not. Where the answer is no, Rule 14 is not engaged and classification follows the other rules — commonly IIa or IIb depending on the device.
The second question arises only if the first is answered yes: is the substance available to the body? MDCG 2022-5 addresses this — a substance fixed in the device matrix so that it does not leach may be considered to have no ancillary action. An additive that releases ions or molecules cannot make that argument.
Classification remains the device manufacturer’s responsibility. What we contribute is the characterisation data the assessment rests on.
Not with respect to that substance. MDCG 2022-5 is explicit: where a manufacturer demonstrates that an incorporated substance has no ancillary action, no benefit claim relating to that substance may be made in the instructions for use, labelling, packaging, advertising, or any other communication. A bare assertion is not enough either — the position must be supported by state-of-the-art scientific data.
This is a real trade-off and worth deciding early rather than late. We would rather discuss it at the start of a project than after a submission strategy is set.
Neque porro quisquam est, qui dolorem ipsum quia dolor sit amet, consectetur, adipisci velit, sed quia non numquam eius modi tempora incidunt ut labore et dolore magnam aliquam quaerat voluptatem. Ut enim ad minima veniam, quis nostrum exercitationem ullam corporis suscipit.