Last April, the Medical Device Coordination Group endorsed this guide for establishing the clinical evidence needed for medical devices previously CE marked under the MDD or AIMDD. This is what we call a “legacy device”.

Sufficient clinical evidence is not defined but it is mentioned in the MDR. To reach sufficient clinical evidence, the amount and quality of the clinical data and clinical evaluation results should “allow a qualified assessment of whether the device is safe and achieves the intended clinical benefits when used as intended by the manufacturer”. The qualified assessment must be done on a continuous basis since the clinical evaluation is a continuous process.

In case you need to perform a first MDR conformity assessment for a legacy device, pre-market and post-market clinical data generated for the purpose of MDD/AIMDD can be considered. However, clinical data used for conformity assessment under the Directives might not provide sufficient clinical evidence for the purpose of MDR requirements.

Post-market clinical data and the clinical data generated for the conformity assessment under the MDD/AIMDD are needed for the clinical evaluation of legacy devices under the MDR. Remember that during the period of validity of the MDD/AIMDD certificates, the MDR requirements for the post-market surveillance apply from the MDR date of application.

Therefore, the additional requirements in MDR concerning post-market surveillance, including post-market clinical follow up are applicable.

Post-market surveillance data and clinical evaluation plans and reports need to be produced and updated.

The MDR compliant clinical evaluation for a legacy device must contain the identification of available clinical data as well as their appraisal / analysis / evaluation and shall lead to a demonstration of conformity to the MDR GSPR based on clinical data providing sufficient clinical evidence as part of a lifecycle approach.

When assessing the conformity of legacy devices under the MDR, it is important to verify whether post-market clinical follow up studies considered necessary under the MDD/AIMDD (and where applicable, during the transition period, under the MDR) have been appropriately conducted, and results are taken fully into account in the clinical evaluation for the conformity assessment under MDR.

Remember that for the clinical evaluation for legacy devices, you should:

• Establish or update a clinical evaluation plan, including:
  • The applicable General Safety and Performance Requirements (GSPR) instead than the Essential Requirements.
  • The specification of the intended purpose, target groups, indications, contraindications.
  • The detailed description of intended clinical benefits with relevant and specified clinical outcome parameters.
  • The specification of methods to be used for the examination of qualitative and quantitative aspects of clinical performance and clinical safety in the clinical evidence, with clear reference to the determination of residual risks and side-effects.
• Identify all available sources of clinical data from pre-market phase, including those from:
  • Clinical investigation reports of your device;
  • Clinical investigation reports or other studies reported in scientific literature of an equivalent device to yours in accordance with the MDR;
  • Reports published in peer reviewed scientific literature on other clinical experience of either your device or a device for which equivalence to your device can be demonstrated;
  • Other pre-market data, e.g. case reports on experience with the use of the device in question, such as compassionate or humanitarian exceptional use reports.
• Identify all available sources of clinical data from post-market phase, including those from:
  • Post Market surveillance clinical data, complaint and incident reports;
  • Post-Market clinical follow up studies, including post-market clinical investigations;
  • Independent clinical studies conducted using the device;
  • Device registries;
  • Data retrieved from the literature.
• Appraise the clinical data sets with respect to their relative contribution to the overall clinical evaluation. This includes an analysis of the methodological quality of data obtained from different sources to identify and assess the level of evidence, bias, other inherent weakness or other possible shortcomings. Clinical data appraisal should be conducted using verified/validated assessment tools.
• Generate new clinical data if data on the devices themselves in the post-market phase are not sufficient.
• Demonstrate compliance with the GSPRs (applicable to the device in question) based on:
  • the usage of reliable, justified and sound analytical methods;
  • results of performed comprehensive analysis;
  • identification of any missing data and/or gaps;
  • determination of post-market clinical follow up.

All the following aspects must be considered:

• clinical benefits,
• risks,
• benefit-risk determination,
• state of the art,
• alternative treatment options,
• the level of clinical evidence available to demonstrate conformity based on clinical data providing sufficient clinical evidence,
• lack of clinical data providing sufficient clinical evidence.

In summary, MDR requires to revaluate the sufficient clinical evidence for legacy devices. Among all, it is important to highlight that the additional requirements in MDR concerning post-market surveillance, including post-market clinical follow up are applicable from the MDR date of application also for legacy devices.

We provided a quick overview on the topic, and we recommend you refer to the MDR, the MEDDEV 2.7/1 rev. 4 guide, the MEDDEV 2.12/2 rev 2 guide and to the MDCG 2020-6 if you need to establish clinical evidence for a legacy device.

If you have questions or need support, please contact us at info.ch@confinis.com.

If you liked this blog and you are interested in clinical evaluation for Medical Device Software, stay tuned for our next post in two weeks!

Authors: Dr. Martina Coscia, Dr. Andrea Biasiucci

Credits: the picture for this blog series has been inspired from a poster by R. Pradhan, S. Shrestha and U. Satyal entitled “Development of a digital tool for risk management, clinical evaluation and post-market surveillance of medical devices” for the 2020EuroConvergence conference.