What Essential Clinical Evidence is Needed for Legacy Devices?

The Regulatory Shift: From MDD/AIMDD to MDR

This shift has introduced more rigorous requirements for clinical evidence, impacting all devices previously CE marked under MDD or AIMDD.

What are the key changes?

What Clinical Data Can You Use to Support Your Legacy Device?

Pre-market:

• Clinical investigation reports of the device concerned.
• Clinical investigation reports or other studies reported in scientific literature for an equivalent device.
• Reports published in peer reviewed scientific literature on other clinical
experience of either the device in question or a device for which equivalence to
the device in question can be demonstrated.
• Other pre-market data, e.g. case reports.

Post-market:

• PMS clinical data, complaint and incident reports.
• PMCF studies, including post-market clinical investigations.
• Independent clinical studies conducted using the device.
• Device registries.
• Data retrieved from the literature.

Note: All clinical data needs to be analysed (where appropriate-appraised) to determine clinical benefits, risks and benefit-risk ratios.

What Factors Does MDR Reinforce, With Respect to the  Clinical Evaluation Report (CER)?

• The acceptability of the benefit-risk ratio.
• Consideration of available alternative treatment options.
• Clinical data.
• Equivalence.
• The incorporation of PMS data.
• The term “clinical evidence” is introduced and the level of clinical evidence.

What Should You Do?

Comprehensive GAP Analysis: perform a thorough analysis of all available clinical data and assess whether sufficient clinical data exists. Assess the quality, relevance, and completeness of the data, involving as required input from statisticians and clinical study experts, if required.

Determine if a clinical study expert is required: if additional clinical data is required, call on a clinical study expert to review, plan and conduct pre (clinical investigations) and post market (post market clinical follow-up) studies.

Ensure robust documentation preparation: ensure your clinical evaluation is comprehensive and well-structured, in particular, collection and presentation of robust clinical data from the literature, supplemented with any available data for your device, providing scientific justifications, including thorough risk analysis and mitigation strategies.

Disclaimer. The views and opinions expressed in this article are solely those of the author and do not necessarily reflect the official policy or position of Test Labs Limited. The content provided is for informational purposes only and is not intended to constitute legal or professional advice. Test Labs assumes no responsibility for any errors or omissions in the content of this article, nor for any actions taken in reliance thereon.