Recently, we described – using a fruit label as an example – how an independent consultancy such as bibra could act as a third-party broker, providing a manufacturer with a safety evaluation of a multicomponent product while also protecting suppliers’ confidentiality over chemical composition. Here, we describe another example, in this case relating to a medical device submission to a Regulator or Notified Body.
Chemical characterisation
A key early step in establishing the biological acceptability of a medical device is the chemical characterisation. From that, your toxicologist learns much about the identity and levels of the chemicals involved, and can review their toxicology profiles, leading to an opinion on risk tolerability and device safety. [Further chemical characterisation, in the form of extractables/leachables studies, might also be needed, depending upon the device and its application category.] However, suppliers of the main materials used in device construction might well be reluctant to divulge full details of their compositions. SDSs usually contain only incomplete data on chemical makeup, and a full toxicological evaluation is not really possible without a complete understanding of the full device composition.
Confidentiality
As described previously, suppliers can provide bibra with detailed compositional information under NDAs, allowing bibra to carry out a full toxicological risk assessment and bibra can provide the device manufacturer with an overview opinion on the device safety without mentioning the relevant chemicals. However, such an overview report would not be sufficient in itself for the purposes of a submission. A Regulator/Notified Body will (quite rightly) expect full disclosure because they need to evaluate the assessment and establish whether they concur with the toxicologist’s conclusions. There is a simple solution to this conundrum, and one we have employed very effectively. The device manufacturer explains to the suppliers that the authority will need full disclosure, and obtains their agreement that bibra can do that. Bibra generates a comprehensive, guideline-compliant, toxicological risk assessment (with named chemicals) on the device, alongside a separate overview report that omits all confidential information. The latter is delivered to the device manufacturer who notifies the authority of an intent to submit. On the submission day, bibra sends the full report directly to the authority.
The Regulator/Notified Body is thus privy to the detailed composition and has a full. independent toxicological risk assessment, the device manufacturer has an overview report stating that independent experts are satisfied over safety, and the suppliers’ confidentiality needs are met. All of this enhances the approval and marketing process, and accelerates the process of getting safe and effective devices to the market and the patients.
[If this service would be of value, don’t hesitate to contact us. We are here to support you on any aspect relating to medical devices and their safety.]