Clinical Evaluation

What is Clinical Evaluation? 

Clinical evaluation is an ongoing procedure to collect, appraise and analyze clinical data on a medical device (or its equivalent) to conclude whether there is sufficient clinical evidence for compliance with relevant General Safety and Performance Requirements (GSPR). Clinical evaluation is required for all medical devices (MDR, Article 61 (1)).

Clinical evaluation is part of manufacturer quality management

Clinical Evaluation should be aligned with and reflected in other aspects of the Technical Documentation, such as:

  •  the interface of the clinical evaluation with the risk management process and its appraisal and analysis of the preclinical and clinical evaluation and their relevance for the demonstration of conformity with the relevant requirements in MDR, Annex I;
  • Post-market surveillance (PMS) including any corrective and preventive actions involving the device;
  • Post-market clinical follow-up (PMCF) plan and, where appropriate the PMCF report; and
  • Instructions for use

What Notified Body (NB) expects from you?

The NB expectations regarding the company clinical evaluation process and documentation are clearly presented in MDCG 2020-13 Clinical evaluation assessment report template (July 2020) guidance.

Clinical Evaluation procedure

The manufacturer needs to have a procedure to keep the clinical evaluation plan up to date, taking into account state of the art (MDR, Annex IX, Chapter I (2.1).

Clinical Evaluation Plan (CEP) & Clinical Evaluation Report (CER)

Clinical Evaluation should be performed by the company Clinical Evaluation Plan (see MDR Article 61 and Part A of Annex XIV). The clinical evaluation results and the clinical evidence on which it is based shall be documented in a Clinical Evaluation Report (CER).

CEP content – For CEP content, see MEDDEV 2.7/1 revision 4 (2016) Sections 7 and MDR, Annex XIV, Part A (1a).

Type of clinical evaluation

You need to provide a statement about the data used in the clinical assessment. The data relevant to the clinical evaluation may be:

  • generated and held by the manufacturer or
  • available from scientific literature, or
  • both

CER should be consistent, self-sufficient and searchable

All product-related info (and others) in CER should be the same throughout the document and reflect what is written in other parts of Technical Documentation, such as labeling, IFU, and promotional materials.

CER should be self-sufficient and contain at least summaries of all referenced documents. You should write in a way it will be understandable for the reviewer.

CER should be in searchable text PDF format with bookmarks. The contents of the clinical evaluation report shall be cross-referenced to the relevant documents that support them.

Regarding the use of MEDDEV 2.7/1 Rev. 4

CER should comply with this MEDDEV guidance in addition to MDR requirements. Review Appendix I in MDCG 2020-6 (Sufficient clinical evidence for legacy devices, April 2020) for the sections of MEDDEV 2.7/1 rev. 4, which are specifically relevant under the MDR.

The literature search should be based on protocol

A literature search should be based on a search protocol that documents the search planning before execution. For the literature search methods and strategy review MEDDEV 2.7/1 revision 4, section A5 and MDCG 2020-13, Section D. The literature data should be retrieved from at least two databases. For, e.g., you can use PubMed & Cochrane Library database. The literature search should clearly distinguish between two types of data: the device under evaluation (or its equivalent device) and the SOA. The literature search should be documented in sufficient detail so that the methods can be appraised critically, the results verified, and the search reproduced if required.

 CER Appraisal

Perform appraisal of identified data based on the appraisal plan that describes the procedure and the criteria for the appraisal. The appraisal could be qualitative and/or quantitative; qualitative data may suffice for the well-established and lower-risk devices. For the possible appraisal method, you can refer to Appendix D of the GHTF SG5/N2R8:2007 on Clinical Evaluation

 CER Benefit/Risk Analysis

Ask yourself whether all the risks that could significantly impact the benefit-risk analysis have been identified in the clinical evaluation? Is there alignment between risk management and clinical evaluation?

 CER Articles

Provide a complete list of retrieved articles and rationale for those which were excluded.

 Position regarding additional clinical investigation

Provide a statement and rationale as to whether further clinical studies or other measures are necessary to generate missing data and eliminate compliance issues. To determine PMCF needs, consider residual risks and any uncertainties or unanswered questions.

 Regarding the CER evaluators

The clinical evaluation should be conducted by a suitably qualified individual or a team; the manufacturer should be able to justify the choice of the evaluators through reference to their qualifications and documented experience and present a declaration of interest for each evaluator.

 

We can assist you with the following tasks:

  • Build strategy to waive or reduce additional clinical investigations
  • Write Clinical Evaluation procedure
  • Write or review Clinical Evaluation Plan
  • Write or review Clinical Evaluation Report
  • Analyze and demonstrate equivalence to the comparator device
  • Review or update a Summary of Safety and Clinical Performance (SSCP)
  • Review or update a Periodic Safety Update Report (PSUR)

If you plan to write your first Clinical Evaluation Report (CER) and don’t know how to start – we advise you to use our CER template, which could be easily customized to your product – see here.

If you are interested in Clinical Evaluation training for the company – please email to: daniel.albahari@bioregservices.com

 

CONTACT US

In order to inquire about our services or ask for immediate regulatory advice for your product, contact us.

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