Medical Device Clinical Evaluation Report

If you are a multinational medical device manufacturing conglomerate or a small medical device manufacturer, intending to import your medical devices to the European market, creating and maintaining a Clinical Evaluation Report [CER] could be a complex and resource demanding task!

A Clinical Evaluation Report (CER) for medical device consists of documents collected either from clinical trials , or from similar or equivalent data search online. The Clinical Evaluation Report conclusion demonstrates your device achieves its intended purpose without posing any risk to patients.

Clinical Evaluation Reports are part of the Technical File submitted to Notified Body. We support Clinical Evaluation documentation as per Article 61 of New MDR and Meddev 2.7/1 Revision 4.

What Is Clinical Evaluation?

As per MEDDEV 2.7/1 Rev.4, Clinical Evaluation is the evaluation of clinical evidence (clinical data) of the medical device under evaluation or such as the scientific publications of substantially equivalent devices, necessary to demonstrate conformity with general relevant safety and performance requirements.

Some of the sources of clinical evaluation that can be favorable or unfavorable are:

  • Data from Clinical Investigations
  • Scientific literature reviews on equivalent device
  • Data from Internal CAPA
  • Post-market Surveillance Data and Post Market Clinical Follow-up Data

MEDDEV Clinical Evaluation is considered as a tool to provide the Notified Bodies with complete overview of the continuous process to demonstrate safety and performance of the medical device. During the process, all data that could provide information on the safety and performance of the device is analysed and assessed.

Clinical Evaluation Procedure

Clinical Evaluation Procedure is to be made in line with the following requirements:

1. Requirements of Clinical Evaluation Procedure as per EN ISO 13485:2016.

ISO 13485 Clause 3.3, Clinical Evaluation assessment and analysis of clinical data pertaining to a medical device requires to verify the clinical safety and performance of the device when used as intended by the manufacturer.

ISO 13485 clause 7.3.7 design and development validation, the organization shall perform a clinical evaluation of medical device in accordance with applicable regulatory requirements.

2. Requirements of Clinical Evaluation Procedure as per MDD 93/42/EEC.

As per Annex X, to establish conformity with the essential requirements concerning the characteristics and performance of the medical devices, a Clinical Evaluation Report shall be written and completed with relevant scientific literatures currently available based on the intended purposes and techniques associated with the medical devices and its use.

3. Requirements of Clinical Evaluation Procedure as per MDR 2017/745 released April 2017

As per Article 5, section 3 of Placing on the Market and putting into service, manufacturer must demonstrate the conformity with the general safety and performance requirements of the medical devices and shall include a clinical evaluation in accordance with Article 61.

As per Article 10, section 3 of General Obligation, manufacturer shall conduct a clinical evaluation in accordance with the requirements set out in Article 61 and Annex XIV, including a PMCF.

As per Article 32, section 2 of Summary of Safety and Clinical Performance, shall summarize safety and clinical performance with at least the aspects of the summary of clinical evaluation as referred to in Annex XIV, and relevant information on post-market clinical follow-up.

As per Article 61 on Clinical Evaluation, the manufacturer shall plan, conduct and document in detail throughout the lifecycle of medical devices in accordance with this article and part A of Annex XIV and shall be updated with the clinical data obtained from PMCF plan in accordance with Part B of Annex XIV and the post-market surveillance plan referred to in Article 84.

Clinical Evaluation Plan

For medical device CE Marking, MEDDEV 2.7/1 Revision 4 recommends Clinical Evaluation Scope which must be analysed and detailed in the Clinical Evaluation Report of each device. The Clinical Evaluation Scope must include Clinical Evaluation Plan in Stage 0. The EU MDR 2017/745 requires that the Clinical Evaluation Plan needs to be attached as a separate document.

Clinical Evaluation Report

Clinical Evaluation Report [CER] should be created and maintained in compliance with the MEDDEV 2.7/1 Rev.4 and the MDD or the MDR 2017/745. The CER, thus consists of the results of the clinical evaluation and the clinical evidence, which will support the assessment of the conformity of the medical device. Clinical evaluation is the methodologically sound on-going procedure to collect, appraise and analyze clinical data of medical devices.

The CER prepared by the manufacturer should convince the European competent authority before obtaining the CE marking for the EU market penetration that their medical device confirms the safety and performance standards. Depending on the risk of the medical devices, the clinical evaluation can be simple, or it can be quite extensive. The depth and extent of the CER will be proportionate to the nature, classification, intended purpose and risk and the manufacturer’s claims on the medical device in question.

CER is a significant portion of the technical file and it is required for all the medical devices irrespective of their classification. A CER should prove that the medical device has undergone rigorous evaluation. It should be continuously updated in accordance with the Post Market Surveillance and/or the Vigilance activities. The clinical evaluation is an on-going process throughout the lifetime of the medical device. Any notable changes that would impact the initial data collection should be recorded and must be appended in the CER.

Advantages of Outsourcing Medical Device Clinical Evaluation To MedDeviceCorp.

MedDeviceCorp Clinical Evaluation Consultants will simplify and organize the Clinical Evaluation documents for early stage Notified Body approval or to safeguard CE Certificate validity.

It needs to be understood that the Medical Device Clinical Evaluation is a recurring activity throughout product lifecycle as far as you are planning for CE Certification or holding a valid CE Certificate. Medical device companies must develop and maintain procedures readily available along with the report and supporting evidences which includes the complete product information, post market surveillance, risk management and equivalent device data.

Looking at the workload and the monumental task of developing and reviewing documentation for their entire medical devices covered in each of the technical files by the company employees, may not be ideal. In a recent report, 68% of medical device companies’ Clinical Evaluation reports prepared and submitted by in-house team are either rejected by the notified bodies or multiple major gaps were found in their CERs and supporting evidences.

When it comes to writing CER, Medical device firms can make the process more efficient through the documentation done by trained external professionals like the Clinical Evaluation consultants of MedDeviceCorp. It is to be noted that the investment needed for the training of in-house team is much higher than hiring a consulting /medical writing company.

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