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Medical Device Clinical Evaluation Report (CER) Development and Review

Under the European Medical Device Regulation (MDR 2017/746), clinical data has been greatly elevated in importance. Notified Bodies expect to see robust clinical data in accordance with MEDDEV 2.7/1 rev 4. Many companies are struggling to meet strict CER requirements, especially for legacy devices. We can help.

How We Help

Let Our MDR CER Team Address These Key Issues for You…

To satisfy the requirements of the European Union Medical Device Regulation, every medical device sold in EU – irrespective of its classification – must have an up-to-date Clinical Evaluation Report (CER) as part of its Technical Documentation.

  • Do we have adequate clinical data to meet EU MDR requirements?
  • How does MEDDEV 2.7/1 rev 4 differ from previous requirements?
  • How much additional preclinical or nonclinical data will be needed?
  • Are our technical literature reviews adequate?
  • How do we determine what is considered current “state of the art”?

Let Us Help You Comply With MEDDEV 2.7/1 rev 4

To satisfy the technical documentation requirements of the EU MDR, every medical device must have an up-to-date clinical evaluation report. MEDDEV 2.7/1 rev 4 “Clinical Evaluation: A Guide for Manufacturers and Notified Bodies” provides a systematic and very robust approach for CER processes. The MEDDEV places much more emphasis on content of the CER, postmarket planning, and supporting clinical evidence. This applies to all medical devices, regardless of class or how long they have been safely sold on the European market.

A 5-Step Approach to CER Compliance

You can't formulate a plan for where you need to be without understanding where you are currently. After working with hundreds of medical device companies – from startups to multinationals – we have found that the following 5-step approach works best.

STEP 1 Define What Clinical Data Is Needed

Define the scope of the clinical evaluation based on the device family, indications for use, performance and safety objectives, clinical benefits, and technological characteristics.

STEP 2 Develop a Clinical Evaluation Plan

Complete a clinical evaluation plan (CEP) that identifies what data will be gathered, analyzed, and compiled for a device or family of devices. This includes evaluating options for equivalence, current state of the art, and potential sources of data (including nonclinical data).

STEP 3 Identify Existing Data and Define Path Forward

Evaluate suitability of clinical data sets, including peer-reviewed clinical literature, for proving safety and performance of the device. We will develop a gap analysis report that defines and prioritizes the risks facing your company and provide recommendations on when and how to mitigate the risks.

STEP 4 Detailed Analysis of All Clinical Evidence

Conduct a thorough analysis of all clinical evidence gathered to determine if your data are adequate to demonstrate compliance with the general safety and performance requirements (GSPR) of the MDR. We will also determine if additional data need to be generated through clinical investigations or postmarket clinical follow-up (PMCF).

STEP 5 Develop or Improve Clinical Evaluation Reports

Compile the clinical evaluation report for the medical device (or device family), outlining how each clinical data set substantiates the safety and performance of the device when used according to its indications for use.

Only Need a Review of Clinical Literature?

Oriel STAT A MATRIX can conduct a safety and performance clinical literature review (using multiple databases) that includes a compliant literature review protocol; identifies, appraises, and analyzes the literature to substantiate the clinical need, safety, and performance; and concludes with a report summarizing the findings.

Not enough staff resources? We also help manufacturers maintain their existing “inventory” of clinical evaluation reports to ensure ongoing compliance with the EU MDR, given that the CERs for many devices now need to be updated annually.

We Are Ready to Help

Oriel STAT A MATRIX has a deep team of regulatory professionals that are well versed in the requirements of the European medical device regulation and, especially, clinical evaluation reports. Contact us today to discuss your needs and how we might be able to assist.

Provided below are a variety of practice related white papers, market updates and case studies.

Oriel STAT A MATRIX’s Goal

Help our life science customers meet regulatory requirements, boost efficiency, and improve patient outcomes

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