Essentials of European Medical Device Regulatory Affairs

MDR Requirements when equivalence is demonstrated Article 61, paragraph 5  A manufacturer of a device demonstrated to be equivalent to an already m rk ted d vice not manufactured by him, may also rely on paragraph 4 in order not to perform a clinical investigation provided that the following conditions are fulfilled in addition to what is required in that paragraph:  the two manufacturers have a contract in place that explicitly allows the manufacturer of the second device full access to the technical documentation on an ongoing basis, and  the original clinical evaluation has been performed in compliance with the requirements of this Regulation,  and the manufacturer of the second device provides clear evidence thereof to the notified body. MDR Requirements when equivalence is demonstrated

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Demonstration of Equivalence

CER should include the following information: • Identification of the equivalent device and its manufacturer (exact name, models, sizes, software versions, accessories, etc…) • Relationship to the device under evaluation (predecessor/ successor, others) • Regulatory status (if not CE-marked, justification for the use of the data) • Level of access manufacturer has to technical and clinical data for the equivalent device • Comparison of clinical, biological and technical characteristics • Comparison of indications, contraindications, precautions, target patient groups, target users, mode of application, duration of use/ number of re-applications, etc • Identification of differences, evaluation of impact on clinical performance and clinical safety of the device, reasons for assumptions made. • Manufacturer conclusions concerning equivalence

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