Medical device manufacturers who wish to sell their products through the European Economic Area must perform a clinical evaluation of their device that is conducted in accordance with Annex X to Directive 93/42/EEC or with Annex 7 to Directive 90/385/EEC. MEDDEV 2.7/1 Rev. 4 does not impose device-specific requirements for these evaluations, as the depth and extent of clinical evaluations should be matched to
A clinical evaluation is an ongoing procedure to collect, appraise and analyze clinical data that pertains to a medical device, to determine whether there is enough clinical evidence to confirm compliance with the relevant essential requirements for safety and performance. MEDDEV 2.7/1 indicates that clinical evaluations should be carried out throughout the life cycle of the medical device, and clinical evaluations are considered mandatory for initial CE-marking of medical devices.
MEDDEV 2.7/1 recommends a five-stage process for conducting a clinical evaluation of a medical device:
Stage 0: Scoping - determine the scope and context of the clinical evaluation, including which products are being tested, what product sizes and settings are covered in the evaluation, an explanation of the technology on which the device is based and any claims made about the device's clinical performance or safety.
Stage 1: Identification of pertinent data - pertinent data can include data that is generated and held by the manufacturer, including from pre-market clinical investigations, as well as data retrieved from literature when required.
Stage 2: Appraisal of pertinent data - the clinical evaluators should create a plan for appraising the data, including criteria for determining the validity of each data set, its relevance to the clinical evaluation, and how each data set should be weighed in terms of its contribution to the overall clinical evaluation.
Stage 3: Analysis of the clinical data - complete the analysis itself, determining compliance with each of the essential requirements relating to clinical performance and safety of the device.
Stage 4: Clinical evaluation report, including post-market surveillance plan - a report must be produced with describes all five stages of the clinical evaluation and outlines what steps will be taken to conduct post-market surveillance and post-market clinical follow-up for the medical device.
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Clause 6.2.3 of MEDDEV 2.7/1 requires that clinical evaluation reports be updated at least annually for new or high-risk devices and every 2-5 years for lower-risk devices. Greenlight Guru's eQMS software ensures that all data generated by your clinical evaluation process is securely stored and accessible, ready to be updated at the first requirement by an authorized member of your team.
Secure cloud storage and document controls ensure that you will never lose any of the important results, literature, data, statistical analysis, risk-benefit analysis, or any other documentation related to establishing the safety, performance, and regulatory compliance of your medical device.