MDR Clinical Evaluation

Clinical Evaluation chapter VI of the new Medical Device Regulation 2017/745, article 61 details general safety and performance requirements to be met by all devices under normal conditions for use for the intended purpose of the device.

A detailed assessment of clinical data with sufficient clinical evidence pertaining to side-effects and acceptability of the benefit-risk-ratio to verify clinical safety and performance is called Clinical Evaluation.

Before obtaining CE Marking in the EU, medical device manufacturers must prove to the competent authority that their device meets the safety and performance standards and hence, the EU MDR necessitates the clinical evaluation of devices. It is required for all medical devices regardless of their classification.

MDR Clinical Evaluation compared to MDD

The requirement to perform Clinical Evaluation found in part I of Annex X of Medical Device Directive (MDD) is inadequate with the expectations. Therefore, the EU authorities published a guidance document Meddev 2.7/1 Rev. 4: Guide for manufacturers and notified bodies.

In the EU MDR, the requirements of Clinical Evaluation can be found in Article 61 and part A of Annex XIV. Part A is focused on pre-market phase and is an extension of part I of MDD Annex X. While the evaluation is still less detailed than the current Meddev 2.7/1 Rev. 4, it states the requirement of (a) Clinical Evaluation Plan (contents specified) (b) evaluation of clinical data and (c) clinical evaluation report (CER).

MDR Clinical Evaluation in Meddev 2.7/1 Rev.4.

Meddev 2.7/1 Rev.4 guides the manufacturers on how to undertake a robust and systematic clinical evaluation and how to demonstrate the scientific validity of the data and conclusions.

Important changes and corrections in Rev.4 are:

Frequency of updates of the CERs (clause 6.2.3)
Qualification of the clinical evaluators or authors (clause 6.4)
Requirement of specific objective for the CER which is to be linked to safety performance and risk-benefit end points (section 7 and appendix 5)
Establishing the State of the Art (clause 8.2)
Requirement of scientific validity of different type of dataset (sections: 8, 9 & 10, Appendices: 5,6& 7)
Detailed information on demonstration of equivalence (appendix 1)
Information on when a clinical investigation is required (appendix 2)
Some detailed information on risk-benefit (appendix 7.2)
Reinforced PMS and PMCF with the clinical evaluation (throughout the guideline)
Role and actions required by the notified bodies (appendix 12)

Due to the important and meaningful changes being introduced by the EU MDR, it is more likely that this guidance will be further revised to align with the upcoming legal requirements.

Frequently asked Clinical Evaluation Report (CER) related questions & answers.

How long does a Notified Body generally take to review the Clinical Evaluation Documents?

Clinical Evaluation Report (CER) review is a part of the Technical Documentation (Technical File / Design Dossier).

Generally, 2 months if the NB identifies appropriate Clinical Expert.

How Clinical Evaluation is related to IFU/User Manual?

Contraindications and warnings mentioned in IFU or User Manual must be considered while performing the systematic literature search during Clinical Evaluation. In other way around, IFU or user manual must be modified based on the outcomes of the Clinical Evaluation.

Will a Notified Body would ever inform a company that the clinical evaluation is inadequate, and need data from clinical trial?

Yes, the Notified Body will inform if they require a clinical trial in the below situations and also if the data are insufficient to prove the medical device safety and performance:

Where the clinical evidence and clinical data are not relevant and accurate to the device in question,
If the device is new with respect to technology,
If the device is new with respect to use, the material of construction and application,
No similar device is available in the market,
Multiple recalls on the similar device is reported.

The risk management and clinical evaluation processes should be inter-dependent and should be regularly updated. Why?

Clinical risks and residual risks from risk management should be considered for clinical evaluation to prove the safety and similarly, any new risk or adverse effect obtained in clinical evaluation should be reflected in the risk management considering the design or material change, if required.

They are updated regularly to prove the continuing clinical safety and performance of the device or for the need of modification/rejection of device from the market based on the adverse event or new risk observed.

External clinical experts - Who are they? What is there role?

External Clinical Experts are clinical professionals who have expertise in the subject device, chosen and trained by the Notified Body (NB) for the assessment of Clinical Evaluation. They provide advice to the NB with respect to the regulations, guidance, common specifications and harmonized standards.

Where can I download MDR Article 61?

Readers can download MDR Article 61 (page 55 of 175)