Medical Device Regulatory Consulting
MDR defines Risk as the combination of the probability of occurrence of harm and the severity of that harm. A Risk Benefit Analysis helps to balance the benefit with the inherent Risk. As per article 10 of MDR, Manufacturers shall establish, document, implement and maintain a system for risk management as described in Section 3 …
A medical device label helps to identify the individual device and to communicate with the user about the safety and effectiveness of the device. Where appropriate the labelling should use symbols and its additional explanation text should be include in information supplied by manufacturer complies with harmonised standard EN ISO 15223-1: 2012 . Apart from …
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Definition of Medicinal Product: According to the second paragraph of Article 1 (2) of Directive 65/65/EEC provides the definition of the medicinal product, ‘Any substance or combination of substances which may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in …
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Medical Device CE Marking 