Clinical Evaluation & Clinical Investigation MEDDEV 2.7.1 Rev.4: 2016

Medzus consultancy of Clinical Evaluation & Clinical investigation in medical device helps manufacturer to maintain & supporting regulatory records to obtain high ethics value to the products.

Medzus follows various harmonised standards and delivers quality services through our highly competent technical expertise. Medzus adheres to widely accepted writing practices and follows GCP while preparing clinical evaluation report according to MEDDEV requirements.

Services as-

  • Clinical Evaluation
  • Clinical Investigation
  • Post Market Clinical Follow-up
  • Post Market Surveillance
  • Vigilance System

 

Summary of Clinical Evaluation:

Clinical Evaluation is to present the data & information to support the clinical safety & effectiveness of the device by review of clinical data, post market clinical incident data, published literatures, and production & post production information.

  • This clinical evaluation is analysis of available pre- and post market data relevant to the intended use of the device, including clinical performance data and safety data.
  • Identify and discuss any literature data on products aimed for a similar indication of product that supports the safety and performance claims of product. The whole process is documented in a clinical evaluation report (CER).
  • This evaluation also address any clinical claims made about the device, the adequacy of product labeling and product information (particularly contraindications, precautions / warnings) and the suitability of instructions for use (IFU).
  • The instructions for use for the device are reviewed during the process to ensure that data is gathered from the same population using the device in the same way for the same indications, as described in the IFU.
  • Essential requirements and Risk Management.
  • Evaluate data in terms of its suitability for establishing the safety and performance of the device generate any clinical data needed to address outstanding issues.
  • Published / unpublished articles of clinical investigations and adverse event reports for the product from the service of the National Library of Medicine and additional life science journals.
  • Evaluate results of clinical (case) studies and Post Market Surveillance data supporting the clinical performance and safety of product.
  • Achieve essential information for assessing clinical benefits and foreseeable risks of product. In case risks are identified, an assessment is made if risks are acceptable when weighted against the clinical benefit and a verification is made if sufficient control measures have been taken including information provided in the Instructions for Use.
  • Assess if product is safe when used as intended and complies with the safety requirements of the MDD 93/42/EEC & 90/385/EEC, Now as per MDR 2017/745.

 

Clinical Evaluation Plan:

Clinical evaluation shall based on the documents of Clinical literature search/Clinical Investigation,

Data & Report with –

  • Current Knowledge and State of the Art in the Medical Field Concerned.
  • Identification and Justification of Potential Equivalent Device(s).
  • Results from Scientific Publications in Journals.
  • Results from Post Market Surveillance Reports.
  • Results from Publicly Available Safety Databases.
  • Results from Other Scientific or Medical Sources.

 

European Legislation

  • MDR 2017/745 

 

International Standards

  • ISO 14155-1: 2003 Clinical investigation of medical devices for human subjects – Part 1
  • General requirements
  • ISO 14155-2: 2003 Clinical investigation of medical devices for human subjects – Part 2 Clinical investigation plan
  • EN ISO14971: 2012 Medical devices – application of risk management to medical devices.

 

 European guidance documents

  • MEDDEV 2.7.1 Rev.4: 2016 Clinical Evaluation: A Guide for manufacturers and notified bodies
  • MEDDEV 2.12/2 Rev.2:2014 Guidelines on post-market clinical follow up.

 

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