May 07, 2025

In today’s evolving regulatory environment, medical device lifetime has emerged as a critical area of focus—especially in light of the Team Notified Body (Team NB) Position Paper released on 15th December 2023. While the EU Medical Device Regulation (EU MDR 2017/745) does not provide a specific definition of device lifetime, it emphasizes through the General Safety and Performance Requirements (Annex I) the need for manufacturers to establish and document device longevity as part of compliance.

This article offers manufacturers an integrated overview of the Team NB guidance and practical steps to define, justify, and communicate the expected service life of medical devices an essential element for CE marking and market continuity.

What Is Medical Device Lifetime?

Medical device lifetime refers to the period during which a device is expected to safely and reliably perform its intended function under normal or foreseeable conditions of use. This includes maintaining compliance with specifications and safety standards throughout its operational life.

Key factors influencing device lifetime include:

  • Mechanical wear and tear: Physical degradation due to use.
  • Material degradation: Changes in device materials over time.
  • Battery life or power source reliability: For active devices.
  • Software obsolescence and updates: Especially relevant for medical device software (MDSW).
  • Reprocessing cycles: For reusable devices, the number of safe reuses.

It is important to distinguish device lifetime from service intervals or maintenance schedules, which refer to periodic upkeep rather than total operational life.

Key Takeaways from the Team NB Position Paper

1. Clear Definition and Justification of Lifetime

Manufacturers must clearly define the device lifetime in measurable terms - such as years, number of uses, or operational hours - supported by robust evidence. Ambiguous or unsupported claims like “unlimited lifetime” are not acceptable.

This definition should be based on:

  • Design inputs and verification data
  • Risk analysis and mitigation strategies
  • Pre-clinical and clinical evidence
  • Post-market surveillance (PMS) and post-market clinical follow-up (PMCF) data

The lifetime claim must be scientifically justified and documented to withstand scrutiny during conformity assessments.

2. Integration into Design and Risk Management

Device lifetime should be an integral part of the design validation and risk management processes. Manufacturers need to:

  • Anticipate potential degradation and performance decline over time.
  • Identify failure modes related to lifetime and evaluate their severity and probability.
  • Define risk control measures that remain effective throughout the device’s lifecycle.

This proactive approach ensures that lifetime considerations are embedded in the product’s safety profile from the earliest stages.

3. Consistency Across Technical Documentation

Lifetime expectations must be consistently reflected across all regulatory documents, including:

  • Design Dossier or Technical File
  • Clinical Evaluation Report (CER)
  • Risk Management File
  • PMS and PMCF Plans
  • Instructions for Use (IFU)

Discrepancies between documents can lead to delays or rejection during regulatory review, so alignment is critical.

4. Clear Labeling and Instructions for Use (IFU)

The device lifetime, along with any relevant conditions or limitations, must be clearly stated in the IFU. This transparency supports safe use by healthcare professionals and patients, ensuring users understand the device’s expected operational duration and any restrictions.

Lifetime Considerations by Device Type

Active Devices

For active devices powered by batteries or electrical sources, lifetime is often expressed in years. Manufacturers should:

  • Analyze component durability and usability.
  • Simulate real-world usage scenarios.
  • Define maintenance and servicing activities.
  • Align clinical follow-up with real-world performance data.

Medical Device Software (MDSW)

For software-based devices, lifetime considerations include:

  • Software versioning and planned obsolescence.
  • Compatibility with evolving operating systems and hardware.
  • Cybersecurity updates and AI algorithm management.
  • Change management and end-of-life planning.

Manufacturers must document how the software remains safe and effective throughout its lifecycle.

Implantable Devices

Implantable devices require lifetime definitions that cover the entire implantation period. Key factors include:

  • Biocompatibility and material endurance.
  • Functional and pre-clinical testing results.
  • Power source longevity for active implants.
  • Benefit-risk assessment over the implantation duration.

Biological Devices

Devices with pharmacological, immunological, or metabolic effects require:

  • Evaluation of absorption or degradation rates.
  • Ongoing risk-benefit assessments.
  • Mechanical integrity for the functional lifetime of the biological component.

Impact on EU MDR Conformity Assessment

Under EU MDR Article 61 and Annex II, Notified Bodies are intensifying scrutiny on lifetime claims. Manufacturers must be prepared to:

  • Justify lifetime parameters with empirical or simulated data.
  • Align lifetime claims with the overall benefit-risk profile.
  • Update PMS and PMCF activities with real-world performance insights.
  • Maintain traceability of all lifetime-related decisions and data.

Failure to adequately define and support device lifetime can result in delays, additional queries, or rejection during conformity assessment.

Best Practices for Manufacturers

To ensure compliance and market success, manufacturers should:

  • Start Early: Define and justify device lifetime during the design and development phases.
  • Leverage Real-World Data: Use field performance, user feedback, and complaint data to validate and refine lifetime expectations.
  • Document Thoroughly: Maintain clear, auditable records of all assumptions, tests, and risk-based decisions related to lifetime.
  • Engage Notified Bodies Early: Seek early feedback during conformity assessment to align expectations and prevent surprises.

 

Conclusion

The Team NB Position Paper offers clear guidance on defining and documenting medical device lifetime under EU MDR. By addressing lifetime early, supporting claims with solid data, and ensuring consistent documentation, manufacturers can achieve smoother regulatory approval and maintain market access with confidence.

If you need expert support with lifetime documentation, risk assessments, or EU MDR compliance, our team at Maven is here to help. From technical documentation to Notified Body interactions, we ensure a smooth path to CE marking and market continuity.