Article supplied by Medilink Member:
Biocompatibility of Medical Devices – Responsibilities of the Supply Chain
The requirement to demonstrate the biological safety/biocompatibility of medical devices is described in EU Medical Device Regulation (MDR). Similar requirements apply in the UK and other regions around the world. All of these regulations indicate that the evaluation process and testing methods described in the ISO 10993 series of standards (Biological Evaluation of Medical Devices) should be used as part of this process. Although it is ultimately the responsibility of the legal manufacturer to demonstrate compliance with the regulatory requirements, and to have appropriate biological evaluation plans and reports in their technical file, members of the supply chain can make significant contributions to this process. There are 3 key areas where suppliers can contribute; addressing specific regulatory requirements, providing biocompatibility study data on manufactured devices/sub components or providing biocompatibility study data on raw materials.
Regulatory requirements – The MDR states that manufacturers should demonstrate conformity with the General Safety and Performance Requirements (GSPRs) set out in Annex I. These include addressing safety concerns over certain chemicals including substances which are carcinogenic, mutagenic or toxic to reproduction (CMR), endocrine disruptors, nanomaterials, and materials of biological origin. These requirements are best addressed by statements provided by materials/components suppliers regarding the presence/absence of such materials. If appropriate statements can not be sourced from the supply chain, then the legal manufacturer may need to resort to complex and expensive chemical analysis to demonstrate conformity.
Component biocompatibility data – if members of the supply chain manufacture significant sub assemblies, or the entire device, then they may be best positioned to arrange appropriate biocompatibility testing and to provide this information to the legal manufacturer. MHRA have recently updated their guidance for virtual manufacturers and Original Equipment Manufacturers (OEM); MHRA – Guidance – Virtual manufacturing of medical devices, v3.0, updated 17 May 2023*. Amongst the guidance, it notes that manufacturers: (a) have to fulfil their obligations themselves regardless of any partial or total outsourcing of the production via subcontractors or suppliers; (b) do not fulfil their obligation to have at their disposal the full technical documentation by referring to the technical documentation of a subcontractor or supplier; and (c) all virtual manufacturers, including those manufacturing Class I medical devices, are required to comply with the revised requirements. These requirements apply to biocompatibility data as well as other technical documentation.
Materials biocompatibility data – Biocompatibility and/or chemical analysis test data on raw materials to be used in medical devices may be helpful in materials selection or supporting changes to an existing device. However, the final device is not just a collection of materials and ultimately it is the biological safety of the final device which must be demonstrated. We have seen EU notified bodies identifying deficiencies such as this when manufacturers rely on a collection of raw material testing data: “the raw material data set is supportive but not suitable and sufficient for demonstration of biological safety of the final finished device as the test items are not representative for possible residues of the manufacturing process and degradation products developing after the sterilization ….”
All of this information should be made available in full to the legal manufacturer for inclusion in their technical file. Rather than seeing this as an additional burden, members of the supply chain should see this as an opportunity to add a commercial advantage to the products they supply to the medical device industry.
When identifying suppliers, device manufacturers are far more likely to work with those who can help providing appropriate data that can help support the biocompatibility of the device. If you are a device manufacturer, or a member of a device supply chain, and have any questions around the biocompatibility of your material or device, then please contact us at [email protected].