Under the Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR), devices need to meet the applicable “harmonized standards” to demonstrate conformity with the essential requirements. If a harmonized standard referenced in the technical documentation (including the DHF) is updated, manufacturers are expected to assess the impact and incorporate any necessary changes to ensure continued conformity with the latest version of the standard.
The specific sections of the MDR and IVDR that require manufacturers to update the technical file when a relevant standard is revised are as follows:
- MDR Article 10(9) – General obligations of manufacturersi
- IVDR Article 10(8) – General obligations of manufacturersii
“Manufacturers shall ensure that procedures are in place to keep series production in conformity with the requirements of this Regulation. Changes in device design or characteristics and changes in the harmonized standards or CS by reference to which the conformity of a device is declared shall be adequately taken into account in a timely manner. Manufacturers of devices, other than investigational devices, shall establish, document, implement, maintain, keep up to date and continually improve a quality management system that shall ensure compliance with this Regulation in the most effective manner and in a manner that is proportionate to the risk class and the type of device.”
When a standard that applies to a medical device or IVD is updated, it may require changes to the technical file associated with the device. The technical file contains all the necessary documentation and information related to the design, manufacture, and performance of the device, and it serves as evidence of conformity with applicable regulations and standards.
As for the U.S. Food and Drug Administration (FDA), it recognizes and references various voluntary consensus standards in the medical device industryiii. These standards serve as important guidelines for manufacturers to ensure the safety and effectiveness of their devices. While compliance with these standards is typically voluntary, they are widely considered industry best practices and may be referenced by the FDA during the regulatory review process. When a voluntary standard that is relevant to the design of a medical device changes, the design documents may need to be updated to ensure compliance with the updated standard. Ensuring compliance with these standards can enhance the safety and effectiveness of your medical device and facilitate regulatory approval from the FDA.
Here are the steps you can take to incorporate the changes into your design documents:
Stay Informed: Regularly monitor updates from the EU, FDA, and other relevant regulatory bodies to stay informed about changes in standards that may impact your medical device or IVD design.
Review the Changes: Carefully review the updated standard to understand the specific modifications and requirements that have been introduced. Identify the sections or clauses that have changed and how they relate to your device’s design and intended use. Conduct a gap analysis to identify the gaps between your current design documents and the requirements outlined in the updated standard.
Perform Impact Assessment: Evaluate the impact of the standard changes on your existing products and design documents.
- Determine which documents, such as design specifications, risk management files, and/or design verification and validation documents, may need to be updated.
- Consider the impact on your risk management documentation, including hazard analysis, risk control measures, or risk mitigation strategies.
Perform any necessary testing: If the updated standard affects any verification or validation activities, modify your protocols or test plans accordingly and perform any necessary testing. Ensure that the testing adequately addresses the updated requirements and can demonstrate compliance with the new standard.
Maintain Regulatory Compliance: Document the results of your impact assessment, including any justifications to not perform any further testing as a result of the updated standard. Update any active regulatory submissions and your product technical documentation with any new test results.
Communication and Training: Communicate the changes to relevant stakeholders, including design teams, quality assurance personnel, and manufacturing partners. Provide appropriate training on the updated standard requirements to ensure everyone involved in the device’s design and development understands and implements the necessary changes.
In summary, while the FDA and EU does not provide explicit guidance on updating the DHF or the technical documentation when a standard changes, both the FDA and the EU expect manufacturers to evaluate the impact of updated standards and incorporate any necessary changes to maintain compliance and demonstrate conformity with the latest requirements. It’s important for manufacturers to proactively monitor updates to relevant standards and assess their impact on the design and development processes of their medical devices and in-vitro diagnostic devices.
[1] https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32017R0745
[2] https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32017R0746
