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Criteria for the exemption of medical Devices from Premarket Clinical consultations

A new interpretation of Medical Device Regulation (MDR) recently updated Article 54 (2)b has been forwarded by the Medical Device Coordination Group (MDCG). According to MDCG, there are certain criteria under which medical devices can be exempted from premarket clinical evaluation consultations to be held before an expert panel.<br>

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Criteria for the exemption of medical Devices from Premarket Clinical consultations

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  1. Criteria for the Exemption of Medical Devices from Premarket Clinical Consultations www.vistaar.ai

  2. Contents 1 Circumstances under which consultation is not required 2 Details to be submitted to the Notified Body 3 About VISTAAR www.vistaar.ai

  3. Criteria for the Exemption of Medical Devices from Premarket Clinical Consultations A new interpretation of Medical Device Regulation (MDR) recently updated Article 54 (2)b has been forwarded by the Medical Device Coordination Group (MDCG). According to MDCG, there are certain criteria under which medical devices can be exempted from premarket clinical evaluation consultations to be held before an expert panel. www.vistaar.ai

  4. Circumstances under which consultation is not required When a firm is undertaking the renewal process under the Medical Device Regulations norms. A manufacturer designs a device through the modification of a pre-existing and pre-marketed medical device and they both serve the same purpose. In such cases, the manufacturer must satisfy the notified body with the ratio of risk and benefit that might be encountered while using this modified medical device. www.vistaar.ai

  5. Circumstances under which consultation is not required 3. If the clinical evaluation principles of the device have been highlighted in a common specification referred to in Article 9 and the same needs to be confirmed by the notified body that the medical device’s clinical evaluation as conducted by the manufacturer is compliant with the form of evaluation needed for the medical device. www.vistaar.ai

  6. Details to be submitted to the Notified Body In addition to the filed application for conformity assessment, the following things are to be submitted by the manufacturer to the Notified Body. a. A statement that the medical device in question has already been marketed as per the previous directive for the pre-intended purpose. b. Last issued certificate’s copy along with its history. c. List of modifications that have been implemented to make the medical device compliant to the Medical Device Regulations www.vistaar.ai

  7. Click here to Read full Article Criteria for the Exemption of Medical Devices from Premarket Clinical Consultations www.vistaar.ai

  8. ABOUT VISTAAR: VISTAAR is a Global Clinical and Regulatory Intelligence Software help the expertise to compete with the top notch professionals. Powered through artificial intelligence (AI) and guided by machine learning (ML), VISTAAR provides automatic clinical and regulatory data in compliance with the global norms. Our regularly updated data offers you a cost effective solution and at the same time saves much of your time. VISTAAR is an active combination of knowledge base and technology. The database is enriched with over 370k+ regulatory information gathered from over 100+ countries. This knowledge is transferred to you through our unique features like Summarize, HUNT, Standards, and Product Intel and so on. www.vistaar.ai

  9. THANK YOU www.vistaar.ai

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