Direct Links to important GMP Medical Device Guidelines

IVD Regulation

This Regulation aims to ensure the smooth functioning of the internal market as regards in vitro diagnostic medical devices, taking as a base a high level of protection of health for patients and users, and taking into account the small and medium-sized enterprises that are active in this sector


Software as a Medical Device: Clinical Evaluation

his document, delivers an approach to making Software as a Medical Device (SaMD) clinically meaningful to users


Medical Devices: Post-Market Surveillance: National Competent Authority Report Exchange Criteria and Report Form.

This document concerns a two way communication system involving confidential information for serious public health issues. This document will provide guidance, procedures and forms for exchange of reports between IMDRF members.


GMP Conferences by Topics

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