Clinical Evaluation Report writing for EU MDR

Learn the process of Clinical Evaluation Report writing and why it is necessary for the medical device industry under the EU MDR.

What is a Clinical Evaluation Report?

Clinical Evaluation process for the EU MDR

A Clinical Evaluation Report (CER) is an important technical document that summarises the Clinical Evaluation of a medical device. A CER details the process, findings and conclusions of Clinical Evaluation, and must be produced in relation to all medical devices under the MDR regardless of risk class.

The MDR - Medical Device Regulation 2017/745, fully in force from May 2021 - replaces the Medical Device Directive (MDD) and introduces a wide range of new regulatory requirements, including for the conduct of Clinical Evaluation and the writing of CERs. Because a properly structured CER is a key requirement for regulatory approval of all medical devices under MDR, it is vital that manufacturers understand the requirements for developing CERs under the new legislation. It is also important that manufacturers have access to a Clinical Evaluation support writer with sufficient knowledge and expertise to meet MDR requirements.

What are the requirements for Clinical Evaluation Reports under the MDR?

Article 61 of the MDR states that the Clinical Evaluation of each medical device shall be documented in a CER that must form part of the technical documentation portfolio for the device. Annex XIV Part A expands upon this requirement and provides detailed requirements for performing a Clinical Evaluation, requiring that the process:

  • is based on a documented plan
  • identifies all clinical data relevant to the device, whether favourable or not
  • appraises clinical data in a robust way
  • establishes a plan for filling any gaps in the clinical evidence portfolio
  • reaches conclusions about the safety and performance of the medical device
Clinical Evaluation Report

Although Annex XIV Part A outlines how to perform a Clinical Evaluation, it is comparatively light on requirements for writing a CER. It states only that “the results of the Clinical Evaluation shall be documented in a CER which shall support the assessment of the conformity of the device.”

More detailed guidance on writing CERs can be found in MEDDEV 2.7/1 rev 4 “Clinical Evaluation: A guide for manufacturers and notified bodies”, an advisory document published by the European Commission. It provides a useful section on CER structure but the guideline has not yet been updated (as of June 2020) to reflect changes in requirements introduced by the MDR. Because of this, adherence to MEDDEV 2.7/1 rev 4 alone will not be sufficient to achieve MDR compliance and manufacturers will need to consult externally for additional advice in order to ensure that MDR requirements have been met.

How should a Clinical Evaluation Report be structured?

According to MEDDEV 2.7/1 rev 4, a basic CER should consist of several sections that incorporate the following information as a minimum:

  • details of the medical device
  • a review of the clinical field the device sits within, including alternative treatments within the field and an assessment of the state of the art
  • appraised clinical data relating to the device and its clinical performance
  • results of Post-Market Surveillance (PMS), Vigilance system and Post-Market Clinical Follow-up (PMCF) activities
  • a benefit-risk assessment
  • an objective conclusion as to whether the device conforms with relevant MDR Annex I General Safety and Performance Requirements (GSPRs)

Each section should be carefully structured to ensure that the document can be understood by an assessor who does not have specialist knowledge of the medical device.

Language used by a CER writer should be scientific, objective and clear, and must convey a balanced appraisal of the device’s safety and performance that is sufficiently robust to meet the demands of regulatory scrutiny. CERs are ideally written by individuals who have a sufficient degree of medical, scientific and regulatory experience to achieve these requirements.

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What happens to a CER after completion?

Following completion, a CER will be assessed as a component of the technical documents required by Annex II MDR to be submitted in support of the device. The procedure by which this assessment will take place will vary according to the risk classification of the device, with a greater degree of regulatory scrutiny being required for higher risk devices.

Manufacturers of Class IIa, IIb and III devices must submit the CER to a Notified Body for regulatory scrutiny as a pre-requisite for achieving permission to affix a CE-mark to the device. The MDR outlines responsibilities for notified bodies in performing assessments of Clinical Evaluation Reports, requiring notified bodies to have access to individuals with sufficient scientific and technical expertise to make a reasoned assessment of the CER.

Manufacturers of Class I devices do not normally need to submit CERs to notified bodies for assessment. However, a Class I device is still subject to the MDR requirements to perform a Clinical Evaluation, demonstrate conformity with the Annex I GSPRs, and demonstrate benefit-risk acceptability. Therefore, a CER is still required for Class I devices and should be written with a similar degree of care and skill to those required for higher risk devices.

Furthermore, some categories of Class I device have special requirements that may require an assessment by a notified body. Class I devices that are supplied sterile, are a reusable surgical device, or have a measuring function, will require involvement of a notified body and manufacturers of these types of devices should prepare CERs with notified body involvement in mind.

Where can I find an expert Clinical Evaluation Report writer?

For devices seeking approval under the MDR, it is extremely important that CERs are produced to a sufficient standard. An experienced CER writer is required: if CERs do not meet the required regulatory standard, regulatory approval for the device could be withdrawn, leading to expensive reparative work, loss of market postion, and loss of customer confidence.

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