Clinical Evaluation under EU MDR

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General Background

Clinical evaluation is a systematic and planned process to continuously generate, collect, analyze & assess the clinical data pertaining to a device in order to demonstrate the safety and performance, including clinical benefits, of the device when used as intended. Clinical evaluation is required under Article 61 and Annex XIV of the European Medical Device Regulation 2017/745 (EU MDR).

This process involves evaluating the available clinical evidence, such as clinical studies, clinical literature and pre-clinical data to demonstrate that the device is safe and effective for its intended use in line with the generally recognized state of the art (SOTA). The clinical evaluation report is an output that summarizes the results of the clinical evaluation process and is used to support the device’s conformity with the EU MDR. The report must be updated regularly throughout the device’s lifecycle to ensure continued compliance with the EU MDR and forms part of the holistic technical documentation for the device.

The clinical evaluation process typically includes the following key documents:

This documentation includes:

The clinical evaluation procedure describes the relevant processes and responsibilities defined by the manufacturer to meet the expectations of EU MDR and relevant state of the art guidance.

To conduct clinical evaluation, the following steps can be taken:

Support & Training

Contact AKRA TEAM for support, hands on implementation services and personalized training by experts with key competencies in the areas listed below.

Key points

  • State of the art (SOTA) is heavily scrutinized during notified body review. A thorough review of the clinical background, medical conditions, guidelines/standards, current medical practice, alternative therapies, similar devices, benchmark devices, SOTA benefit-risk analysis and benchmarks of safety and performance are expected to be provided.

  • Clinical claims for the subject device must be specified in the CER and supported with sufficient clinical data.

  • Clinical benefits shall be defined for every device and linked to appropriate measurable performance outcomes. The clinical benefit should reflect the intended purpose of the device.

  • Safety and performance outcomes should be quantitative and patient relevant established from benchmark values obtained from the state of the art literature review.

  • Choosing the correct clinical strategy is key under EU MDR. Whether the device can claim equivalence, well-established technology, clinical data not deemed appropriate (Art 61(10), or sufficient. The subject device will dictate the quality and quantity of clinical evidence required.

Our Services


AKRA TEAM provides training regarding general Clinical evaluation and CER writing as well as specific topics regarding SOTA, safety and performance outcome development, clinical strategy and more.

Process and Templates Development

Proven procedure and document templates are available for all aspects of clinical evaluation including:

  • Clinical evaluation procedure
  • Clinical Evaluation Plan
  • Clinical Evaluation Report
  • Literature Search Protocol/Report
  • State of the art (SOTA) structure

Gap Assessment

AKRA TEAM offers comprehensive gap assessments of clinical documentation to highlight areas of risk or improvement prior to submission. AKRA TEAM will rank risks from high to low while offering mitigations to close any identified gaps.


AKRA TEAM has an experienced team of medical writers, clinicians and regulatory experts available to write clinical evaluations and related documentation for all device categories and risk-classes. We offer custom tailored solutions or comprehensive solutions to addresses the needs of any manufacturer. Additionally, if the clinical evaluation is currently under review we can provide targeted updates based on any open deficiencies.

Continuous update of documentation

AKRA TEAM additionally offers solutions for continuous documentation updates. AKRA TEAM will schedule and revise documentation at defined intervals to ensure regulatory compliance is maintained according to the expectations of EU MDR.

Interested in our services?

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