ISO 10993-1 revision nears critical deadline

Medical device manufacturers should take note that the ballot phase for the Final Draft International Standard (FDIS) of ISO 10993-1 closes on 15 July 2025.

With just days remaining, Mike Picchioni, Associate Director Regulatory Affairs at G&L, outlines what you need to know and how to prepare for the significant changes ahead.

What’s happening?

The Final Draft International Standard (FDIS) of the revised ISO 10993-1: Biological evaluation of medical devices Part 1 was released on 22 May 2025.

This revision marks a major shift in how biological safety is assessed. It affects all medical devices that come into contact with patients, whether active, non-active, implantable, or non-implantable.

Why it matters

ISO 10993-1 is a cornerstone of biological safety assessment. It outlines how to evaluate medical devices within a risk management framework, including:

• General principles of biological evaluation
• Device categorization based on body contact
• Evaluation of existing relevant data

The new version brings expanded requirements and a shift in strategy, moving away from rigid test plans toward flexible, risk-based evaluation.

Key obligations and opportunities for manufacturers

Once published, the updated standard will apply to all new and existing medical devices. Here is what manufacturers will need to do:

• Ensure new medical devices meet the updated requirements
• Review Risk Assessments, GSPR checklists, and Biological Evaluation Reports for all existing devices
• Prepare a Biological Evaluation Plan (BEP) for each device
• Apply risk management and scientific evaluation to determine required tests in place of predefined test paths, potentially reducing unnecessary testing for low-risk devices

What’s changing in the standard?

This is not a routine update. Key changes in the revised ISO 10993-1 include:

New title and scope:

• Title changed to: “Requirements and general principles for the evaluation of biological safety within a risk management process”
• Emphasis on risk-based approaches integrated with ISO 14971

Categorization updates:

• Devices are now classified by nature and duration of body contact, including:
  • Intermittent contact
  • Contact with:
    • Intact skin
    • Intact mucosal membranes
    • Breached/compromised surfaces
    • Blood

Expanded biological hazards and effects:

• New considerations include:
  • Absorption through skin/mucosa (e.g., barrier creams)
  • Neurotoxicity
  • Genotoxicity (now applies to all devices with prolonged contact, except intact skin)
  • Carcinogenicity (applicable to long-term mucosal contact)

Lifecycle-based risk assessment:

• Greater emphasis on changes over time:
  • Device degradation
  • Material breakage
  • Long-term exposure risks

Risk-based data gap analysis:

• Manufacturers will be expected to:
  • Identify gaps in current biocompatibility data
  • Determine additional data needs through risk analysis
  • Develop a Biological Evaluation Plan outlining how to address those gaps

What’s not included

The standard does not cover hazards related to:

• Bacteria, moulds, yeasts, and viruses
• TSE agents
• Other infectious pathogens

Final thoughts: Act now

The revised ISO 10993-1 places risk management at the heart of biological evaluation, with implications for every stage of the device lifecycle, from design to post-market.

With the 15 July ballot deadline fast approaching, now is the time to:

• Review your portfolio
• Assess the impact for each marketed device
• Assess the impact for devices under development
• Begin planning for compliance

This update represents a fundamental change for new submissions and the ongoing safety assurance of devices already on the market.