Direct Links to important GMP Medical Device Guidelines

Medical Device Regulatory Audit Reports

The scope of this guidance document is limited to the information that participating MDSAP Regulatory Authorities require in medical device regulatory audit reports, the format of reports and the information necessary for participating MDSAP Regulatory Authorities to effectively use the audit reports in accordance with their legislation.

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WHO Global Model Regulatory Framework for Medical Devices including in vitro diagnostic medical devices

regulatory framework for medical devices, invitro diagnostics

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FDA Medical Device Reporting for Manufacturers

This guidance document describes and explains FDA´s current regulation that addresses reporting and recordkeeping requirements applicable to manufacturers of medical devices for device-related adverse events and certain malfunctions.

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Requirements for Medical Device Auditing Organizations for Regulatory Authority Recognition

In the past, various Regulatory Authorities have identified shortcomings in the standards being utilized for the recognition of organizations that conduct medical device audits for regulatory purposes. These standards were considered to be too generic and focused on commercial entities for commercial purposes. However, many organizations that work in the regulated environment of medical devices must comply with these generic requirements for other purposes.

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Common Data Elements for Medical Device Identification

This document outlines the common data elements for medical device identification that may be used through regulatory activities or processes, including the future possibility of electronic regulatory submission of device identification information. This document will cover the harmonization of terms and their definitions.

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Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions

FDA has developed this guidance document to provide clarity for FDA staff and industry regarding the benefit and risk factors FDA may consider in prioritizing resources for compliance and enforcement efforts to maximize medical device quality1 and patient safety.

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Medical Device Regulation

This Regulation aims to ensure the smooth functioning of the internal market as regards 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.

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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

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Software as a Medical Device: Clinical Evaluation

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

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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.

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GMP Conferences by Topics

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