Medical device evaluation procedures
Manufacturers shall carry out an assessment of the conformity of the product prior to placing on the market.
In accordance with the following evaluation procedures:
- Based on a quality management system and the evaluation of technical documentation: The manufacturer will implement, and maintain it throughout the life cycle of the product, a quality management system, subject to Audit by the selected Notified Body.
- The application of the quality management system will guarantee compliance with the legislation applicable to the manufactured product.
- The Notified Body will carry out a complete review, by personnel with sufficient experience and knowledge, to ensure that the product conformity assessment is compliant and sufficient and that it has been documented in accordance with the applicable requirements.
- Type-Examined-Based: A procedure by which a Notified Body checks and certifies that a product, including its technical documentation, its relevant processes during the life cycle of the product, and a corresponding representative sample of production, complies with the relevant legally established provisions.
- The manufacturer shall apply in writing to the Notified Body for its request.
- The Notified Body will review the application by personnel with knowledge and experience in the technology and intended purpose. It will examine the technical documentation to ensure compliance with the applicable legislation.
- Review the clinical evaluation report.
- It will document its conclusions by means of a report, in a report of the preclinical and clinical evaluation.
- It shall carry out or cause to be carried out the tests necessary to confirm compliance with the General Requirements.
- It shall carry out the necessary tests to confirm that the Harmonised Standard selected by the manufacturer is suitable.
- Draw up the type EU examination report.
- Based on the verification of product conformity: It aims to guarantee that the products are compliant for the type for which the CE Marking certificate has been issued. Once the EU examination certificate has been issued, the manufacturer may apply the production quality assurance procedure or the product verification procedure:
- Production quality assurance: The manufacturer shall ensure that the approved quality management system is in place and shall be subject to appropriate monitoring.
- Product verification: This is the procedure by which, after examining each manufactured product, the manufacturer issues an EU declaration of conformity, guaranteeing and declaring that the products have undergone the appropriate procedure and are in conformity with the type defined in the certificate issued by the Notified Body.
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