Medical Device Clinical Evaluation Report

EU MDR Clinical Evaluation

The EU MDR Clinical Evaluation, as outlined in Chapter VI of the Medical Device Regulation (MDR) 2017/745, particularly in Article 61, sets forth the General Safety and Performance Requirements (GSPR) that all medical devices must meet under normal usage conditions for their intended purpose. Clinical Evaluation is a systematic and thorough assessment of clinical data to ensure that there is sufficient evidence regarding the safety, performance, side effects, and the acceptability of the benefit-risk ratio of a device.

EU MDR Clinical Evaluation Documentation

Under the new MDR 2017/745, manufacturers are faced with the significant challenge of updating their Clinical Evaluation Report (CER) documentation across their entire product portfolio. This task is critical and must be completed before submitting the technical documentation, which includes the CER, to Notified Bodies for CE Certification.

It has become evident from inquiries received globally that a large percentage of device manufacturers are currently unprepared for the comprehensive demands of MDR compliance. Many lack a clear strategy to address gaps in their clinical documentation, including processes for literature review, CER planning, and clinical data collection—essential elements for achieving CE Marking under the new MDR requirements effective from May 2021.

During the transition to MDR compliance or when applying for new CE Marking with Notified Bodies, many manufacturers continue to face uncertainty regarding the specific requirements detailed in Article 61 of MDR 2017/745. This uncertainty is causing delays in achieving compliance, which is a significant concern for those navigating the new regulatory landscape.

EU MDR Clinical Evaluation Report

The EU MDR Clinical Evaluation Report (CER) has long been a requirement for high-risk medical device manufacturers, but following high-profile scandals that raised concerns about the adequacy of existing standards, the European Commission introduced the more stringent Medical Device Regulation (MDR) in May 2017. This new regulation, MDR 2017/745, significantly tightens the requirements for CERs to ensure better patient safety and device performance.

To achieve and maintain CE Certification under MDR 2017/745 and secure authorization to market medical devices within the EU, every device classified as Is, Im, Ir, IIa, IIb, or III must have its technical documentation, including the CER, rigorously evaluated and approved by a Notified Body.

At Iqzyme, we assist our clients in preparing EU MDR Clinical Evaluation Reports in strict accordance with Article 61 and Annex XIV of the MDR, as well as the guidelines set forth in MEDDEV 2.7/1 Rev 4. Our CER writers are experts with a strong background in biology or related scientific disciplines and possess deep expertise in medical device regulation, development, patient usage, and design technology. This expertise ensures that the CERs we produce meet the stringent requirements necessary for CE Marking and regulatory compliance in the EU.

EU MDR Consultant

Collaborating with an EU MDR consultant is a strategic move for any organization aiming to achieve regulatory compliance efficiently. By leveraging the extensive experience and specialized skills of outsourced experts, organizations can significantly enhance the quality of their Clinical Evaluation Reports (CERs). Working with an external EU MDR consultant allows the regulatory compliance team to focus on other critical day-to-day tasks, improving overall productivity.

For organizations lacking the necessary in-house expertise in CER writing, literature search, or technical documentation preparation, Iqzyme offers professional EU MDR consulting services. Our consultants are well-versed in MDR Article 61 and MEDDEV 2.7/1 Rev 4, bringing cross-platform experience and deep regulatory knowledge to every project, enabling us to begin work immediately and ensure successful outcomes.

Attempting to manage MDR compliance tasks in-house often requires hiring, training, and supporting new employees, which can be costly and time-consuming, with no guarantee of success. The coordination between EU MDR clinical evaluation consultants and internal team members is crucial for the successful completion of projects.

MDD vs MDR Clinical Evaluation

Under the Medical Device Directive (MDD), the requirement for Clinical Evaluation, as outlined in Annex X, Part I, was insufficient to meet current expectations. As a result, the EU authorities issued the guidance document MEDDEV 2.7/1 Rev 4 to provide clearer direction for manufacturers and notified bodies.

In contrast, the MDR Clinical Evaluation requirements are more stringent and detailed, as specified in Article 61 and Part A of Annex XIV. Part A focuses on the pre-market phase and expands upon the MDD Annex X requirements. The MDR now mandates (a) a Clinical Evaluation Plan (CEP), (b) thorough evaluation of clinical data, and (c) a comprehensive Clinical Evaluation Report (CER).

EU MDR Clinical Evaluation Plan

Manufacturers needing to demonstrate the safety and performance of a medical device through clinical data must develop a robust EU MDR Clinical Evaluation Plan (CEP). This plan should outline a comprehensive strategy for identifying, collecting, and analyzing clinical data according to a well-defined schedule. The CEP must cover the scope of the clinical evaluation, taking into account the device's intended use, indications, and current state of the art. This ensures that all relevant aspects of the device's performance and safety are thoroughly evaluated in line with EU MDR requirements.

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