Question: One of my medical device suppliers provided me with a supplier declaration for raw materials. On it, they reference “Pharmaceuticals and Medical Devices ISO 10993 & USP Biocompatibility” instead of the EU Medical Device Regulation (EU 2017/745). What is the difference between ISO 10993 and EU 2017/745? Does the declaration need to be updated to show “no substances over the limit” and list the directive?
Answer: The EU Medical Device Regulation (MDR) introduced a complete overhaul of existing medical device regulations by placing new and updated requirements on manufacturers to:
- Implement QMS standards (ISO 13485).
- Implement identification of substances contained within medical devices against referenced substance lists.
- Perform appropriate risk assessments (understand risk exposure scenarios, identify alternative substances, justify the use of a substance > 0.1% w/w threshold).
- Update packaging and labeling information.
You may not use an ISO 10993 declaration instead of an EU MDR declaration. EU MDR is focused on the identification and use of substances, performing risk reviews and justifying the use of a substance. The substances used need to be listed if they are on the suppliers products.
The ISO 10993 analysis is likely to be conducted ‘at a specific point in time’ reflecting the biocompatibility testing. It’s expected that ISO 10993 will be added to the list of harmonized standards being developed for supporting EU MDR substance declarations. ISO 10993 would form part of the analysis and justification for a medical device, but not a replacement for any product substance reporting. In response, you should:
- Complete the EU MDR template, stating if any EU MDR substances appear on the supplied products.
- Ensure your declaration shows both substances on products above threshold, and no substances on products above threshold.
- Attach the ISO 10993 declaration as supporting documentation to the EU MDR declaration, so the customer can evaluate the data to assess risk.
This content is accurate as of May 24, 2019.