ISO 10993-1, the core standard for the biological evaluation of medical devices, has been under revision over the past few years. A Final Draft International Standard (FDIS) was published earlier this spring, and the voting was closed the July 17. The standard was approved and is now under publication.

What’s changing?

The new version of ISO 10993-1 strengthens the alignment between biological evaluation and risk management principles.

Key changes include:

  • Closer integration with the risk management process as defined in ISO 14971. The biological evaluation is now more explicitly linked to the stages of the risk management process.
  • A revised method for calculating total exposure, focusing on the number of days from first to last exposure, rather than total contact time.
  • The table in former Annex A covering biological endpoints is replaced by several smaller tables integrated into the main text. The term biological endpoint is replaced by the term biological effect. The tables list which effects to consider for different types of device contact (intact skin, mucosal membranes, internal tissues, circulating blood). Notably, material-mediated pyrogenicity is no longer listed as a biological effect in any of these tables.
  • New requirements for the Biological Evaluation Plan, which should include or reference criteria for the acceptability of specific biological risks associated with the medical device.
  • A new annex with guidance on characterization

What does this mean for you as a manufacturer?

Manufacturers will be expected to apply the new version whenever a biological evaluation needs to be updated (for example, due to changes in the device design, materials, or manufacturing process).

To prepare, we recommend performing a gap analysis of your current biological evaluations against the new standard. In particular, consider the following:

  • Does the revised method for calculating total exposure change which biological effects you need to evaluate? If so, plan ahead to ensure future compliance.
  • Do your SOPs and templates for biological evaluation need to be updated? If yes, take steps to align them with the new requirements.

How we can support you

At Aurevia (formerly QAdvis), we closely monitor regulatory developments and help our clients stay ahead of changes. We offer:

  • Gap analyses and documentation reviews
  • Support in updating biological evaluations

Want to know more?

Feel free to reach out if you’d like to discuss how the upcoming version of ISO 10993-1 may affect your products and documentation. We’re here to help you stay compliant, informed, and ready.

 

Post-Market Surveillance (PMS) is more than complaint handling – it’s a strategic tool for patient safety, regulatory compliance, and continuous improvement. Under the EU MDR, a structured, proactive approach with strong links to risk management and authority dialogue is essential.

PMS has become a cornerstone of regulatory work under EU MDR 2017/745 and IVDR 2017/746. It’s not just about responding to incidents – it involves systematically and continuously collecting, analyzing, and acting on real-world data from medical device use, both from one’s own products and from competitors. The goal is to detect hidden risks, prevent recurring issues, and strengthen patient safety.

In my work with PMS and vigilance – both as a regulatory assessor at the Swedish Medical Products Agency (Läkemedelsverket) and as a consultant – I’ve seen how often PMS is mistaken for simple complaint handling. That’s a dangerous oversimplification. True PMS is integrated into the quality management system and requires collaboration with distributors, importers, and authorized representatives. Deficiencies in documentation, traceability, or training can lead to serious consequences, including recalls or regulatory intervention and, in the worst case, severe patient harm.

Five Common Pitfalls in PMS – and How to Avoid Them

  1. Insufficient documentation and traceability:
    Missed safety signals can be costly. Establish clear processes for collecting, recording, and analyzing data.
  2. Passive data collection:
    Don’t wait for incidents to arise. Be proactive – use (e.g. real-world information from healthcare professionals using the device), PMCF/PMPF studies, and market feedback.
  3. Neglecting old products:
    Older products may develop new issues over time. Continue monitoring even years after market entry.
  4. Lack of clear event investigation procedures:
    When something happens – gather all relevant information, including the affected product, determine the root cause, update the risk analysis, and implement CAPAs.
  5. Poor communication and training:
    Your representatives, distributors, and resellers need the right knowledge to identify and report incidents in time.

Success Requires a Structured PMS Process:

  • A clear plan for data collection, analysis, and reporting.
  • Continuous monitoring of all products – including those already in use.
  • Engagement in regulatory dialogues with authorities and notified bodies for quicker risk mitigation and transparency.
  • Alignment with guidance documents such as MDCG 2023-3.
  • Sufficient resources – with the option .

Final Note
PMS reflects an organization’s approach to quality. It’s about viewing issues as opportunities for learning and improvement – not as failures. An active and effective PMS system is not just a regulatory requirement; it’s essential to protect both patients and your company’s future.

Contact us to learn how we can support you with PMS strategy, documentation, training, and regulatory guidance – so you can focus on what matters most: safety.