International Benchmarks both in Health and GRPs are critical elements to consider while working towards advancing the Regulatory Convergence agenda, as well as to prevent the creation of Technical Barriers to Trade.

A wealth of resources to learn and apply these benchmarks are available in a condensed form in here.

International References

World Health Organization

The WHO has four principle international benchmark documents constituing the global consensus regarding medical device regulatory frameworks and guidance for medical device national regulatory authorities.

Global Model Regulatory Framework for Medical Devices Including IVD Medical Devices
Good regulatory practices in the regulation of medical products
Good reliance practices in the regulation of medical products: high level principles and considerations
Guidance for post-market surveillance and market surveillance of medical devices, including in vitro diagnostics

World Trade Organization

The WTO has one principle international benchmark document constituting the global consensus and treaty-based legal obligations regarding regulatory processes applicable to medical device regulatory frameworks medical device national regulatory authorities.

Technical Barriers to Trade Agreement (TBT)

WTO/TBT website
WTO/TBT Agreement Text
English
Spanish
Portuguese

International Medical Device Regulators Forum (IMDRF)

The IMDRF maintains dozens of international benchmark documents constituting the global consensus regarding medical device regulatory frameworks and guidance for medical device national regulatory authorities. The following IMDRF documents comprise the core IMDRF guidance, beginning with the “N47 – Essential Principles”.

International Medical Device Regulators Forum (IMDRF) documents (all), including:

2a. IMDRF N47 – “Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices”
2b. IMDRF N51 – “Optimizing Standards for Regulatory Use”
GHTF/SG1/N071/2012 – Definition of the terms “Medical Device” and In Vitro Diagnostic (IVD) Medical Device
GHTF/SG1/N055:2009 “Definitions of the Terms Manufacturer, Authorized Representative, Distributor and Importer
GHTF/SG1/N77:2012 – Principles of Medical Devices Classification
WG/N64FINAL:2021 – Principles of In Vitro Diagnostic (IVD) Medical Devices Classification (formerly GHTF/SG1/N045:2008)
IMDRF/GRRP WG/N52 FINAL:2019 Principles of Labeling for Medical Devices and IVD Medical Device
IMDRF/UDI WG/N7FINAL:2013 – UDI Guidance Unique Device Identification (UDI) of Medical Devices
IMDRF MDCE WG/N57FINAL:2019 (formerly GHTF/SG5/N3:2010) – Clinical Investigation
IMDRF MDCE WG/N56FINAL:2019 (formerly GHTF/SG5/N2R8:2007) – Clinical Evaluation
IMDRF MDCE WG/N55 FINAL:2019 (formerly GHTF/SG5/N1R8:2007) – Clinical Evidence – Key Definitions and Concepts

Medical Device Single Audit Program (MDSAP)

The MDSAP is a global approach to auditing and monitoring the manufacturing of medical devices. The MDSAP allows an MDSAP recognized Auditing Organization to conduct a single regulatory audit of a medical device manufacturer that satisfies the relevant requirements of the regulatory authorities participating in the program.

International Standards

There are over 200 international standards from standards developing organizations (SDOs) that are used by medical device regulatory authorities and industry for regulatory purposes. These documents are developed in open processes consistent with the requirements of the World Trade Organization, are updated at pace with technological changes and constitute the global consensus regarding medical device technical requirements.

A compendium of these standards is included within the following two standards from the International Organization for Standardization (ISO):

ISO 16142-1:2016 – Medical devices — Recognized essential principles of safety and performance of medical devices — Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards
ISO 16142-2:2017 – Medical devices — Recognized essential principles of safety and performance of medical devices — Part 2: General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards

These documents can be obtained via the 168 ISO member national standards bodies, or for MDRC project countries, through the MDRC.