Direct Links to important GMP Medical Device Guidelines

Software as a Medical Device (SaMD): Key Definitions

This document IMDRF SaMD WG N10/Software as a Medical Device: Key Definitions focuses on a common definition for when software is considered to be a medical device and a reminder of other key terms, some previously defined in Global Harmonization Task Force (GHTF) documents, with relevance to SaMD.

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UDI System for Medical Devices

This guidance provides a framework for those regulatory authorities that intend to develop their own UDI Systems – such that, when implemented, it achieves a globally harmonized approach to UDI.

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COMMISSION RECOMMENDATION of 24 September 2013 on the audits and assessments performed by notified bodies in the field of medical devices

The Recommendation aims at ensuring that the notified body carries out a proper verification of the fulfilment of the legal requirements by the manufacturer.

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COMMISSION IMPLEMENTING REGULATION (EU) No 920/2013 of 24 September 2013 on the designation and the supervision of notified bodies under Council Directive 90/385/EEC on active implantable medical devices and Council Directive 93/42/EEC on medical device

The common interpretation of the criteria for designation provided by this Regulation does not suffice to assure their consistent application. The assessment methods in the Member States differ. They have a tendency to differ ever more due to the mentioned increased complexity of the work of conformity assessment bodies. Furthermore, many ad hoc questions arise in the day-to-day designation practice, in relation with new technologies and products. For these reasons, it is necessary to provide for procedural obligations which ensure a constant dialogue between Member States on their general practices and on ad hoc questions. This will bring to the surface discrepancies in the methods used to assess the conformity assessment bodies and in the interpretation of the criteria for their designation set out in Directive 90/385/EEC and Directive 93/42/EEC. Bringing the discrepancies to the surface will permit to develop a common interpretation of the assessment methods, especially with regard to new technologies and

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Requirements for Medical Device Auditing Organizations for Regulatory Authority Recognition

This is one document in a collection of documents produced by the International Medical Device Regulators Forum (IMDRF) intended to implement the concept of a Medical Device Single Audit Program (MDSAP). This document applies to Auditing Organizations that audit medical device manufacturers and may perform other related functions.

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Competence and Training Requirements for Auditing Organizations

This document applies to recognized Auditing Organizations conducting audits of a medical device manufacturer for regulatory purposes. Adherence to this document and its requirements will help mitigate the risk of inconsistent or ineffective assessments of manufacturers by ensuring that Auditing Organization personnel have the necessary commitment, competence, experience, and training before conducting an audit or undertaking a decision making function.

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Non-In Vitro Diagnostic Device Market Authorization Table of Contents (nlVD MA ToC)

This document was developed for non-In-vitro diagnostics device (nIVD) market authorization submissions. Market authorization submissions for combination products are out of scope; refer to each specific regulator for guidance regarding combination products.

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In Vitro Diagnostic Medical Device Market Authorization Table of Contents (IVD MA ToC)

This document was developed for in-vitro diagnostics medical device (IVD) market authorization submissions. Market authorization submissions for combination products are out of scope; refer to each specific regulator for guidance regarding combination products.

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Software as a Medical Device": Possible Framework for Risk Categorization and Corresponding Considerations

The purpose of the document is to introduce a foundational approach, harmonized vocabulary and general and specific considerations, for manufacturers, regulators, and users alike to address the unique challenges associated with the use of SaMD

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

This document provides guidance on: • the criteria to be used for deciding when to exchange information, • the procedures to follow when exchanging information, • the forms to use for exchanging information, • the requirements for IMDRF members participation in the NCAR Exchange Program.

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GMP Conferences by Topics

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