clinical evaluation

The manufacturer of a medical device must produce a clinical evaluation report, CER, to document the  clinical evaluation  and its result.   MEDDEV Guideline 2.7 / 1 rev.4 defines  clinical evaluation  as a procedure that involves the collection, estimation, analysis, and evaluation of available clinical data to support the compliance of the medical device with the Essential Requirements.   The clinical evaluation report or CER must contain sufficient information to be read and understood by an independent agent. You must provide sufficient detail to understand the search criteria adopted by the evaluators, the available data, the assumptions made, and all the conclusions reached.   WHAT MUST CONTAIN IN A CER The report must describe the different stages of the  clinical evaluation  :   Stage 0, the scope of clinical evaluation : - explains the scope and context of the assessment, the technology on which the medical device is based, t...

   Getting a clinical information technology system challenges every company's senior administration team. Unlike various other management applications that aid take care of a center, the clinical information technology system touches directly the lives of people as well as the workflow of medical professionals, nurses, as well as other clinicians. Professions and also whole companies can be ruined by bad supplier selections and also botched applications (e.g., setup of the software application and hardware) as well as implementations (e.g., the intro of applications to end-users). Improperly selected clinical information technology systems can drive doctors to rival institutions, impact facility accreditation, and in many cases welcome lawsuits because of unforeseen morbidity or mortality.  Clinical evaluation  is an ongoing process and is first conducted during the development stage of the medical device throughout its life cycle.    As frightening as thi...

When you start a project to import products subject to a prior import license, mainly cosmetics, health products, and food, you find two alternatives to start: Authorize your facilities and obtain your license or sanitary registration number as an importer. Subcontract importation activities to an already authorized third party. In this second case, the repercussions on the ownership and responsibility of imported products must be taken into account in order to protect the present and future rights of the entrepreneur, especially if a private brand is to be implemented or a strong investment in marketing is to be made  Technical File  . In the event of subcontracting the import activities, all legal rights and responsibilities over the products fall on the importing company, leaving the company or person initiating the project as a mere commercial intermediary  Medical Device CE Marking  . Although confidentiality and exclusivity agreements are signed between both pa...

  According to Annex VIII of the new EU Regulation 2017/745, the classification of medical devices is based on the intended use and the worst-case rule (the highest applies between the multiple applicable classes; the most critical of the multiple intended uses applies).   Substance-based DM : non-invasive consisting of a substance or mixture of substances, intended for in vitro use, fall into class III . Invasive DMs : they fall into class I if their duration of use is temporary; in- class IIA if the duration is short-term; in-class IIB if long-term. Invasive surgical DM : for short and medium-term use they fall into class IIA; if absorbed or administering medicinal products are in class IIB; if related to the heart, they fall into class III . Class III also includes breast and ear implants, surgical nets, disc prostheses, and active implants. Medical software : class IIA if the software provides...

  The requirements for the   periodic safety update report   are defined in Article 86 of the   EU MDR   2017/745. Specifically, the PSUR should include: the conclusion of the risk-benefit analysis the main results of the post-marketing  clinical follow-up Sales volume of the device and other characteristics of the population using it and, where possible, frequency of use of the device. The PSUR must be prepared for each medical device or category of medical device and must include the results and conclusions of the  post-market surveillance  analyzes data collected as a result of the  post-market surveillance plan  together with a justification and description of any preventive actions and corrective measures undertaken. Benefit-risk analysis The benefit-risk analysis is part of the  risk management process  and must be performed throughout the life cycle of the medical device. The assessment of the risks and benefits of the d...

  The requirements for the periodic safety update report are defined in Article 86 of the EU MDR 2017/745. Specifically, the PSUR should include:   the conclusion of the risk-benefit analysis the main results of the post-marketing clinical follow-up Sales volume of the device and other characteristics of the population using it and, where possible, frequency of use of the device.   The PSUR must be prepared for each medical device or category of medical device and must include the results and conclusions of the post-market surveillance analyzes data collected as a result of the post-market surveillance plan together with a justification and description of any preventive actions and corrective measures undertaken.   Benefit-risk analysis   The benefit-risk analysis is part of the risk management process and must be performed throughout the life cycle of the medical device. The assessment of the risks and benefi...

  The clinical evaluation of medical devices is undoubtedly one of the cornerstones of the new regulation. It is a very complex institution, the application of which requires an in-depth analysis of the regulation itself and which can help to dispel some doubts.   What is clinical evaluation? The clinical evaluation is a systematic and planned process aimed at continuously producing, collecting, analyzing, and evaluating clinical data relating to a device to verify its general safety and performance , including clinical benefits, when it is used as intended by the manufacturer.    It is therefore a business process that must be "systematic" and "programmed" and which aims to produce clinical data. The collection and analysis of such data serve to verify the safety and performance of the medical device.   What is clinical data? Clinical data is information relating to the safety and performance of the device. Such data can come from 4 sources” ...