Clinical Evaluation Report Template

We are confident that the clinical evaluation report templates are of the highest quality and that they adhere to MDCG, MDR and the MEDDEV 2.7/1 Rev. 4 requirements.

The CER templates cover all aspects of clinical evaluation reports, including selecting and analyzing clinical data, assessing the state-of-the-art, and identifying clinical risks and benefits. By having access to these templates, companies can save a lot of time and effort in writing their reports. Instead of starting from scratch each time, they can utilize the clinical evaluation report template to create their reports more efficiently.

The templates are not designed for the general public. These CER templates are drafted for professionals such as PRRC, MR, QA, RA, subject experts and technical writers engaged in MDR /UKCA technical documentation inhouse without the need for consulting support.

We have developed procedures for each activity involved in clinical evaluation, and corresponding templates have been created for each procedure. These documents and contents have been developed based on our extensive experience from multiple submissions to notified bodies for various classes of devices. They are presented in a format that has consistently obtained approval from Notified Bodies.

The clinical evaluation procedure describes the entire clinical evaluation process, from defining the scope and plan through to the Clinical Evaluation Report. It gives detailed instructions on:

• Defining the scope and plan of the clinical evaluation
• Identification of pertinent data
• Literature search and review
• Appraisal of pertinent data
• Analysis of clinical data
• Generating the CER

It instructs your QA/RA team on how to carry out each activity in line with MDR 2017/745 and MEDDEV 2.7/1 Rev 4, specifying for every step what needs to be done, when, and what must be documented and reported.

Both the QMS standard and the MDR require it:

• EN ISO 13485:2016, clause 7.3.7 requires the organisation to perform clinical evaluations as part of design and development validation, in accordance with applicable regulatory requirements.
• MDR Article 5(3) requires demonstration of conformity with the General Safety and Performance Requirements to include a clinical evaluation in accordance with Article 61.
• MDR Article 10(3) obliges manufacturers to conduct a clinical evaluation in accordance with Article 61 and Annex XIV, including PMCF.
• MDR Article 61(3) requires the clinical evaluation to follow a defined and methodologically sound procedure, and Article 61(11) requires it to be updated throughout the device lifecycle with data from the PMCF plan (Annex XIV Part B) and the post-market surveillance plan.

No exemption is allowed for legacy devices. Devices previously CE marked under the MDD must still have a clinical evaluation plan and report that meet MDR requirements. MDCG 2020-6 provides guidance on the clinical evidence expected for legacy devices, and its Appendix II sets out the minimum content of a clinical evaluation plan for legacy devices.

Yes. The quality of a CER depends on the experience of the people preparing it, and our CER writers have experience preparing reports and answering Notified Body questions. We offer two options:

• Full-Service Option: a comprehensive package that includes the services of a clinical evaluator.
• Standard Option: for new or patented devices, our standard service without a clinical evaluator.

See our CER writing fees for pricing.

All documents are made in Microsoft word. No limitation on use.

We will NOT issue a refund once the softcopy document has been submitted.

The purchased softcopy document will be accompanied by an attached copy of the invoice. The invoice will be from PayPal, and there will be no separate or alternative invoice provided.

The files you purchased are NOT instantly downloaded.

However, within 1-5 hours of receiving the payment confirmation (excluding Sundays as they are holidays), you will receive an email. Please ensure to check the email address provided during the purchase process.

The email will contain a DROPBOX link through which you can access and download the purchased files or documents.