Clinical Evaluation Procedure

Clinical Evaluation Consultants and Writers

Clinical Evaluation according to MDR article 61 and MEDDEV 2.7/1 Revision 4 states that every medical device affixing CE Logo, regardless of its classification, must have a clinical evaluation report in its Technical Documentation

The Directive specific focus on implantable or class III medical devices gives the false impression that clinical investigation does not apply to other Medical devices. This has lead to the current situation where clinical trials are rarely done in the pre-market steps of development.

Clinical investigation is rarely conducted because of the investment in time, human resources and costs. In addition, clinical investigation is sometimes perceived as risky or harmful. As with the implementation of MDR, clinical evaluation has become a central element of regulatory compliance.

Manufacturers face the greatest impact, as they must present complete and sufficient clinical evaluation files to ensure timely assessment and favorable review of their products.

Benefits of Conducting Clinical Evaluation

  1. Regulatory conformance: Conforming to the regulatory framework is necessary and should be done in order to get Notified Body approval for Technical file followed by CE Certification. Choosing to perform a clinical investigation is the best answer to conform to the new requirements of MDR article 61
  2. Early detection and resolution of safety issues: Over 25% of safety alerts are due to manufacturing defects. This high proportion demonstrates the importance of an early detection of potential safety issues. Early assessment gives the manufacturer time to take corrective action and to provide potential damages to the company reputation.
  3. Manufacturer Image: An early clinical evaluation most often results in a positive image and greater usage of the product throughout the healthcare system. A well-designed clinical investigation based on a robust methodology gives a chance to publish a scientific article in a peer-reviewed journal.

How regulatory Consultants helps in Clinical Evalaution (CER)

Medical Device Clinical Evaluation is an ongoing procedure to collect, appraise and analyses clinical data pertaining to a medical device in question. The data from any equivalent devices, scientific literature about the target device, current knowledge of the dieseas condition to be treated, and information held by the manufacturer about benefit risk, pre-clinical including clinical trials and or any clinical investigations, post-market surveillance, and the IFU / User manual. The clinical data are analyzed for consistency and to identify any gaps or uncertainties that require further evaluation, and to show the safety and performance of the device with GSPR requirements in MDR.

Regulatory Consultants provide strong support in above described areas during Clinical Evlaution of Medical Device

How Medical Writers helps in Clinical Evalaution (CER)?

CER writers systematic approach includes support in protocol generation, develop fast method to complete clinical evaluation documentation and complete proper and detailed conclusion with the touch of an expert.

  1. Experience count!! and will reduce the challenge of meeting the CER MDR article 61 by writing a clear and concise document that effectively communicates the relevant data.
  2. Expert and comprehensive review of clinical data derived from various sources to demonstrate performance and safety of the device and results of studies on equivalent devices
  3. Inclusion of regularly updated systematic literature reviews of the relevant State of the Art and of published reports relevant for assessing the device`s performance and safety