MDCG 2025-8 Rev. 1, Guidance on the implementation of the Master UDI-DI [Unique Device Identification-Device Identifier] solution for spectacle frames, spectacle lenses and ready-to-wear reading spectacles, was released by the Medical Device Coordination Group in March 20261. The changes introduced…
All Class II medical devices (including in vitro diagnostic (IVD) reagents) and all Class I IVD reagents manufactured from 1 June 2027 onwards must bear a Unique Device Identification (UDI)1; devices produced before that date do not require unique identification.…
Normative Instruction No. 426 of 13 February 2026, which entered into force on 1 March 2026, establishes the requirements for the transmission of data to, and management of, Brazil’s Unique Device Identification (UDI) database1. Medical devices must have their UDI…
At the 29th meeting of the Global Harmonization Working Party (GHWP) in Bangkok, Thailand on 4 December 2025, the following Working Group (WG) guidance documents were endorsed1 according to the simple majority rule: WG1-WG2-WG3, Guidance on Determining of Lead Authority…
Medical Device Coordination Group guidance document MDCG 2025-8, Guidance on the implementation of the Master UDI-DI solution for spectacle frames, spectacle lenses and ready-to-wear reading spectacles, was published in November 20251. This document aims to provide guidance on the implementation…
Guidance on how medical devices must comply with the Essential Principles was updated in November 2025 to include information on Essential Principle 131. Essential Principle 13 of Schedule 1 to the Therapeutic Goods (Medical Devices) Regulations 2002 specifies the requirements for information…
Interested parties had until 23 January 2026 to submit comments on a proposal to support sponsors who may not be able to meet the new Unique Device Identification (UDI) requirements by the compliance deadline1. In March 2025, the Therapeutic Goods…
Comments are being accepted until 6 December 2025 on a Draft Resolution of the Cabinet of Ministers of Ukraine ‘On Approval of the Technical Regulation on Medical Devices’ to update1 the provisions of the current Technical Regulation on Medical Devices…
In August 2025, the new [unique device identification] UDI Devices module in the national medical device database, swissdamed, became operational1. This module allows for the registration of medical devices, in vitro diagnostic devices, and systems and procedure packs. Devices authorised…
The Directorate for Medical Products has submitted for consultation, on behalf of the Ministry of Health and Care Services, proposals for amendments1 to Regulation No. 1476 of 9 May 2021 on medical devices. The consultation, which runs until 17 November…
Introduction The Unique Device Identification (UDI) system is a fundamental component of the medical device regulatory framework in Europe, which was established to strengthen traceability, improve post-market surveillance, and enhance patient safety. The UDI system uses a standardised coding system…
Comments have been sought recently on several proposed documents issued by the Global Harmonization Working Party (GHWP): UDI Application Guidance Considerations for Manufacture to facilitate an effective UDI Implementation1 This document provides an introduction and explanation regarding unique device…
Commission Delegated Regulation (EU) 2025/1920 of 12 June 2025 concerning the assignment of unique device identifiers for spectacle frames, spectacle lenses and ready-to-wear reading spectacles was published in the Official Journal on 23 September 20251. A discussion of the adopted…
Minor changes have been made in the first revision of Medical Device Coordination Group guidance MDCG 2024-14 Rev. 1, Guidance on the implementation of the Master UDI-DI [Unique Device Identification-Device Identifier] solution for contact lenses1. On page 4 of the…
Comments are being solicited on a draft guidance for industry and Food and Drug Administration staff entitled, Unique Device Identifier (UDI) Requirements for Combination Products1,2. This draft guidance outlines the requirements, recommendations, and best practices for UDI labelling and for…
The Medical Device Coordination Group (MDCG) Position Paper 2025-7 has been released1 to clarify the timelines for the implementation of the Master UDI-DI (Unique Device Identification-Device Identifier) for contact lenses, spectacle frames, spectacle lenses and ready-to-wear reading spectacles, as established…
Following a period of public consultation, the European Commission adopted a Delegated Regulation on 12 June 20251 concerning the assignment of unique device identifiers for spectacle frames, spectacle lenses and ready-to-wear reading spectacles. Regulation (EU) 2017/745 on medical devices provides…
All Class IV medical devices manufactured from 10 July 2025 must display their Unique Device Identification (UDI) on their labels1. Circular Letter No. 2/2025/SEI/GGTPS/DIRE3/ANVISA2 has been published to provide guidance on the provisions of Resolution RDC No. 591/2021 that became…
The phased introduction of mandatory Unique Device Identification (UDI) compliance begins on 1 July 2026, starting with high-risk devices1. At the relevant time, it will be mandatory for manufacturers and sponsors supplying most medical devices in Australia to identify their devices with…
A period of public consultation has been held on a draft Commission Delegated Regulation amending Regulation (EU) 2017/745 on medical devices with respect to the assignment of Unique Device Identifiers (UDIs) for spectacle frames, spectacle lenses and ready-to-wear reading spectacles1.…
Comments are being accepted until 26 May 2025 on a draft Normative Instruction that establishes the requirements for the transmission of data to, and management of, the database on the Unique Device Identification (UDI) of medical devices1, as established by…
Sponsors and manufacturers have been provided with new guidance1 to help them understand their regulatory obligations under the Australian Unique Device Identification (UDI) system for medical devices and in vitro diagnostics. The guidance outlines the requirements for obtaining and applying…
Global Unique Device Identification Database (GUDID) – Guidance for Industry and Food and Drug Administration [FDA] Staff was issued on 17 December 20241, superseding guidance of the same name from June 2014. This guidance update reflects upcoming changes to the…
In November 2024, the Medical Device Coordination Group (MDCG) released guidance on the implementation of the Master UDI-DI [unique device identification – device identifier] solution for contact lenses (MDCG 2024-14)1. This guidance sets out the relevant terminology, rules for assignment…
Commission Implementing Decision (EU) 2024/2120 was published on 1 August 2024 to renew the designation of the four issuing entities designated to operate a system for the assignment of Unique Device Identifiers (UDIs) in the field of medical devices1. Commission…
In October 2024, the second phase of the pilot project for Unique Device Identification (UDI) implementation began, and will run until the first half of 20251. During this second phase, new functionalities will be implemented. The plan is to register…
A tabulated summary of the UDI requirements, with hyperlinks to the legislation, for Australia, Brazil, China, Egypt, the European Union, India, Korea (Republic of), Malaysia, Saudi Arabia, Singapore, Taiwan, Turkey and the USA. AUSTRALIA Links https://www.tga.gov.au/how-we-regulate/manufacturing/manufacture-medical-device/unique-device-identification-udi-hub Comments In February 2021,…
On 7 June 2024, the Medical Device Authority launched the first phase of a pilot survey to assess the readiness of medical device establishments in Malaysia to provide all the information required for the Unique Device Identification (UDI) of their…
Revision 3 of the Regulatory Guidelines for Software Medical Devices – A Life Cycle Approach1 has added a new paragraph to section 3.4, Design Verification & Validation, to read: ‘A traceability analysis should be provided that links product design requirements,…
In response to a Decision from the General Registration Technical Committee Meeting, the Medical Device Authority (MDA) has determined1 that, from 1 January 2024, only the recognised Quality Management System (QMS) standards stated in Table MY1 will be accepted for…
In November 2023, the Global Harmonization Working Party (GHWP) finalised and released the following guidance documents: GHWP/WG1-WG2-WG3/F002:2023, Principles of Regulatory Requirements for Electronic Instructions for Use (eIFU)1 GHWP/WG2/F001:2023, Guidance for Additional Considerations to Support Conformity Assessment of In vitro…
On 20 October 2023, the European Commission published1 Commission Delegated Regulation (EU) 2023/2197 to amend Regulation (EU) 2017/745 on medical devices (MDR) with respect to the assignment of unique device identification device identifiers (UDI-DIs) for contact lenses. The published text…
Comments were accepted until 3 October 2023 on Working Group 9’s proposed document entitled GHWP [Global Harmonization Working Party] UDI [Unique Device Identification] Rule1. This document outlines a UDI system, which should include a UDI identifier, a UDI carrier, and…
Introduction Unique Device Identification (UDI) provides important regulatory and supply chain functions for medical devices. It allows for tracking of devices throughout the global supply chain to the patient, it offers global visibility to device adverse event reporting, and it…
On 10 July 2023, the European Commission adopted1 the text for a Delegated Regulation to amend Regulation (EU) 2017/745 on medical devices (MDR) with respect to the assignment of unique device identification device identifiers (UDI-DIs) for contact lenses. The draft…
Two Decrees relating to the obligations for registration and storage of unique device identification (UDI) information by healthcare institutions and healthcare professionals for medical devices1 and in vitro diagnostic medical devices (IVDs)2 have been published in the Italian Official Gazette.…
Comments have been sought on a proposal to create a single identifier for similar, highly individualised medical devices under the European Union’s Unique Device Identification (UDI) system1. Regulation (EU) 2017/745 on medical devices (MDR) provides for a UDI system for…
A list of Class II devices that must meet China’s Unique Device Identification (UDI) requirements from 1 June 2024 has been published by the National Medical Products Administration1. These devices include single-use products with great clinical demand, devices listed in the scope…
New requirements for the creation and affixing of Unique Device Identification (UDI) information to medical devices to aid traceability throughout the supply chain came into force on 1 May 2021. These UDI requirements were phased in gradually, starting with the…
To help stakeholders prepare for end of the Food and Drug Administration’s (FDA’s) enforcement policy regarding use of National Health Related Item Code (NHRIC) and National Drug Code (NDC) numbers on device labels and packages, it has posted a frequently…
A period of public consultation has been held on a third batch of medical devices for which Unique Device Identification (UDI) will be required1 based on the degree of risk they pose and regulatory needs. These devices include single-use products…
A period of public consultation has been held on the following three proposals: Draft amendment of the Charge Standards of Administrative Fees for Medical Devices1: addition of a fee of NT$30,000 for Good Distribution System inspection or its follow-up…
Final guidance has been published1,2 entitled Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices, Direct Marking, and Global Unique Device Identification Database Requirements for Certain Devices, which updates the previous guidance from July 2020. The updated…
In February 2021, the Australian Parliament amended the Therapeutic Goods Act 1989 to enable the establishment of a Unique Device Identification (UDI) database. The Therapeutic Goods Administration (TGA) has now consulted on the proposed regulatory requirements needed to operationalise the…
Answers have been provided1 to some of the most commonly asked questions on the Unique Device Identification (UDI) system established under Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). The…
On 26 June 2022, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) published1 its response to the consultation on the future regulation of medical devices and in vitro diagnostics (IVDs) in the UK. The consultation was held between September…
The dates for complying with Saudi Arabia’s Unique Device Identification (UDI) system for medical devices have been postponed for a second time1,2. Entering information in the UDI database for Class D (high risk) medical devices was originally postponed from 1 August…
Clarification has been provided on the identification information that must be included on a medical device recall incident report form1. According to paragraph 1 of Article 16 of the Measures for the Administration of a Medical Device Recall, if a…
On 10 January 2022, Resolution RDC No. 591/2021 came into force, specifying the identification of medical devices through a Unique Device Identification (UDI) system1. This Resolution applies to all medical devices regulated by the National Health Surveillance Agency (ANVISA), except…
Labellers of soft (hydrophilic) contact lenses have been granted another extension1 to comply with the requirements of the Unique Device Identification (UDI) system established by a 2013 final rule2. The Food and Drug Administration (FDA) had already granted two extensions…
