Most medical device companies that currently sell CE-marked medical devices are getting nervous thinking about implementation of EU-MDR compliance and new certification. Especially related to the necessity to present sufficient clinical evidence to support the general safety and performance requirements. The Medical Devices Regulation applicable as of 26 May 2020 will significantly raise the bar for clinical data.
Among the new requirements:
A clinical evaluation plan and a clinical evaluation report is required for all device including class I.
The clinical evaluation shall follow a defined and methodological sound procedure and be based on MEDDEV 2.7.1/rev.4 and Annex XIV of the MDR
Especially related to the necessity to present sufficient clinical evidence to support the general safety and performance requirements
The clinical data should be sufficient to demonstrate compliance with the safety and performance requirements .
The clinical evaluation should include a critical evaluation of the results of all available clinical investigations whether positive or negative
The method of appraising the literature need to be documented to assure your critical evaluation, without any bias or underexposure of unfavorable data.
Consideration of currently available alternative treatment options for that purpose
State of the artagainst which to measure safety and performance must be established from Literature Review
In order to rely on clinical evidence of an similar device already marketed, the biological, technical and clinical equivalence will need to be demonstrated scientifically. Furthermore manufacturer will need to have sufficient access to design data of the t device with which he claims equivalence.
Results of clinical investigations and/or Post Marketing Clinical Follow Up Studies that you performed in the past or that are currently ongoing, will be very valuable for your clinical evaluation. Similarly results from your post market surveillance process including some form of active collection of data will also represent an important input into your clinical evaluation which will be part of your Technical Fileto be assessed by your Notified Body.
It is therefore urgent for all medical devices manufacturers to critically and objectively analyze the foundation of their Clinical Evaluation Report and assess whether they have clinically sufficient evidence for future MDR compliance? Some devices will surely lack sufficient clinical evidence and might indispensably require some form of active data collection (PMS/PMCF).
As EU Consultant, Obelis can help you understand the new requirements, perform a gap analysis, and assist you to develop a solid plan for clinical data compliance.