Medical Device Clinical Evaluation Report – Medral Global
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 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 face the significant challenge of updating their Clinical Evaluation Report (CER) documentation across their entire product portfolio. This critical task must be completed before submitting technical documentation, including the CER, to Notified Bodies for CE Certification.
Globally, many device manufacturers remain unprepared for the comprehensive demands of MDR compliance. Numerous organizations lack a clear strategy to address gaps in their clinical documentation, such as literature review processes, CER planning, and clinical data collection—key elements for achieving CE Marking under the MDR effective from May 2021.
During the transition to MDR compliance or when applying for new CE Marking with Notified Bodies, many manufacturers experience uncertainty regarding specific requirements detailed in Article 61 of MDR 2017/745, causing delays in compliance—a significant concern in the evolving regulatory landscape.
EU MDR Clinical Evaluation Report
The EU MDR Clinical Evaluation Report (CER) has long been mandatory for high-risk medical device manufacturers. However, following high-profile scandals highlighting deficiencies in previous standards, the European Commission introduced the stricter Medical Device Regulation (MDR) in May 2017. MDR 2017/745 significantly tightens CER requirements to ensure better patient safety and device performance.
To obtain 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 Medral Global, we assist clients in preparing EU MDR Clinical Evaluation Reports strictly in accordance with Article 61 and Annex XIV of the MDR, as well as guidelines in MEDDEV 2.7/1 Rev 4. Our CER writers possess strong backgrounds in biology and related scientific disciplines combined with deep expertise in medical device regulation, development, patient usage, and design technology. This 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 approach to achieving regulatory compliance efficiently. Leveraging the extensive experience and specialized skills of external experts significantly enhances the quality of Clinical Evaluation Reports (CERs) while enabling your internal regulatory team to focus on other critical operations.
For organizations lacking in-house expertise in CER writing, literature search, or technical documentation preparation, Medral Global 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. This allows us to begin work immediately and ensure successful outcomes.
Attempting to manage MDR compliance internally often requires hiring, training, and supporting new employees, which can be costly and time-consuming, with no guaranteed success. Effective coordination between EU MDR clinical evaluation consultants and internal teams is essential for timely and successful project completion.
MDD vs MDR Clinical Evaluation
Under the previous Medical Device Directive (MDD), the Clinical Evaluation requirement (Annex X, Part I) was insufficient to meet modern expectations. Consequently, EU authorities issued the guidance document MEDDEV 2.7/1 Rev 4 to clarify requirements for manufacturers and Notified Bodies.
In contrast, 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 MDD Annex X requirements. The MDR 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 device safety and performance through clinical data must develop a robust EU MDR Clinical Evaluation Plan (CEP). This plan outlines a comprehensive strategy for identifying, collecting, and analyzing clinical data according to a defined schedule. The CEP must address the scope of the clinical evaluation, considering the device’s intended use, indications, and current state of the art. This ensures all relevant aspects of device performance and safety are thoroughly evaluated in line with EU MDR requirements.