MDCG 2021-6 Updated: MDR Q&A Regarding Clinical Investigations
13 December 2023
UK MHRA Medical Device & IVD Registration: Step-by-Step Guide
18 December 2023Table of Contents
Team NB released a new position paper today, to provide guidance regarding medical device lifetime. It is available: HERE
Overview
The paper aims to:
- Create a common understanding of the term ‘medical device lifetime’
- To “…promote consistency in approach…and…”to provide an overview of existing guidance and standards”
- Illustrate (generally) how manufacturers may determine a device’s lifetime for active, software (MDSW), implantable, and biological devices
- Further, set expectations on what manufacturers are expected to consider and manage, as part of the device lifetime planning
- Identify the relationship between medical device lifetime and clinical data requirements
- Provide a brief overview of statistical analysis methods
- Provide Team Notified Body’s recommendations to manufacturers
Recommendations from Team NB
Below are snippets of each recommendation.
- Manufacturers are expected to define the time period for lifetime or expected lifetime or service lifetime in the technical documentation and the instructions for use.
- “Unlimited lifetime or undefined lifetime is practically impossible to claim” and “lifetime is expected to be defined in quantitative terms of number of years, number/intensity of uses, or operational period.
- Device lifetime should be part of design inputs where possible, and include testing and acceptance criteria as part of design outputs. It should be clear how each element determining the device’s lifetime was verified, with supporting evidence for normal conditions of use.
- Clinical data can be used for supportive evidence of a device’s lifetime, e.g., from post-market surveillance. The device’s positive benefit-risk profile must be maintained throughout its lifetime.
- “Where there is no clinical study data available, data from literature, or whether a PMCF study is required, as well as applicable device characteristics and pre-clinical performance evaluation…could be considered”.
- Manufacturers may provide justifications for their device testing and analysis methods. However, “any such justification should correspond to reasonable risk of severity and likelihood of failure modes for the device and SOTA [state of the art] irrespective of procedures, and take into consideration how long the device is reasonably likely to be safe and effective for use and of the duration in the body (where applicable) to decommission.”
Please refer to the Position Paper for the full overview.
Further Reading
Overview: Shelf-life, Expiration Date, Expected Lifetime/Useful Life, Service Life, Lifecycle
