Certificates of Free Sale, Manufacturing Certificates and Export Certificates will be issued electronically from 1 March 20261. Upon completion of the application and successful payment, the electronic certificate will be issued by the Medical Device Authority via email within seven…
The first edition of a guidance document entitled the Application for Confirmation Status of Obsolete and Discontinued Medical Devices (MDA/GD/0071) was published in March 20261. This document provides advice to industry players and healthcare professionals on the control and management…
An updated version of the International Medical Device Regulators Forum (IMDRF) technical document IMDRF/AE WG/N43, Terminologies for Categorized Adverse Event Reporting (AER): terms, terminology and codes, was published on 3 March 20261. The following Annexes to the technical guidance have…
The second edition of ISO 20417:2026, Medical devices – Information to be supplied by the manufacturer, was released in March 20261. ISO 20417 specifies the general requirements for information supplied by the manufacturer for medical devices and accessories, including identification,…
ISO 14155:2026, Clinical investigation of medical devices for human subjects – Good clinical practice (Edition 4) was published in March 20261. This standard specifies Good Clinical Practice (GCP) for the design, conduct, recording and reporting of clinical investigations carried out…
A Working Draft of ISO/AWI 8250, Cleanliness of medical devices – Process design and test methods, has been approved for registration as a Committee Draft1. This draft standard deals with the cleanliness of medical devices immediately after production (i.e. before…
Amendments have been proposed to the Medical Devices Rules, 2017 which would, among other things, add a new fee schedule for tests and evaluations as the Ninth Schedule to the Rules1. The proposed fees are listed in Table IN1 below.…
Guidance has been drafted1 for importers to assist them in the submission of product licence applications to the Central Drugs Standard Control Organisation (CDSCO) through ‘cdscomdonline’ and the National Single Window System (NSWS). The draft guidance specifies the information required…
The Central Drugs Standard Control Organisation’s In Vitro Diagnostic Medical Devices Division has released a second Addendum (dated 13 March 2026)1 to its frequently asked questions document CDSCO/IVD/FAQ/04/20222. This second Addendum adds 24 questions relating to the Medical Devices Rules,…
Interested parties have until 5 May 2026 to submit comments on the draft Clinical Evidence for IVD Medical Devices – Definitions and Principles of Performance Evaluation from the International Medical Device Regulators Forum (IMDRF)1. This document supersedes earlier documents produced…
Technical Reference document TR-010, Combination Products, was published on 1 April 2026 and became effective immediately1. This document aims to describe different categories of combination products and their examples. It also provides a reference regarding whether combination products meet the…
On 26 February 2026, the International Medical Device Regulators Forum (IMDRF) published technical document IMDRF/GRRP WG/N89, Playbook for Medical Device Regulatory Reliance Programs1. Although primarily intended for regulators, this document is relevant to all medical device stakeholders. The purpose of…
A consultation is being held until 10 July 2026 on the draft Technical Framework for Artificial Intelligence Life Cycle Management1. This document provides an internationally harmonised technical framework to help promote responsible innovation and a focus on patient needs by…
The Finnish Medicines Agency (Fimea) has published a clinical investigation plan template1 designed to ensure that clinical studies meet the basic requirements of both Regulation (EU) 2017/745 on medical devices and Finland’s national legislation. The new template provides a clear…
The Order of 24 February 2026 established the list of medical devices for individual use that may be restored to good working order pursuant to Article L. 5212-1-1 of the Public Health Code1. The medical devices for individual use that…
With the entry into force of Section 374a of Book Five of the German Social Code (SGB V), manufacturers of assistive devices and implants will be responsible1, from 1 July 2027, for offering interoperable interfaces so that collected health data can…
Technical Reference documents TR-007, Medical Device Software and Cybersecurity and TR-008, Artificial Intelligence Medical Devices have been updated and came into effect on 3 February 2026. TR-007, Medical Device Software and Cybersecurity1 The February 2026 update has modified the…
Mandatory use of four EUDAMED modules for medical devices will begin on 28 May 20261. The transition periods for these modules, where applicable, are as follows: Actor Registration: requirements apply to manufacturers, Authorised Representatives, importers, and system and procedure…
On 23 April 2026, an update was made to the manufacturer incident report (MIR) form (version 7.3.1)1. Use of this updated form becomes mandatory on 1 May 2026 for reporting serious incidents under Regulation (EU) 2017/745 on medical devices and…
Revised versions and new documents have been published in relation to the European Medical Device Nomenclature (EMDN): MDCG 2026-3 (April 2026) is an Excel spreadsheet of the EMDN 2026 version plus historical versions1; MDCG 2026-2 (April 2026) is an…
In the second quarter of 2026, the European Medicines Agency (EMA) intends to launch a pilot programme to support breakthrough medical devices and in vitro diagnostics (IVDs)1. The aim is to test a pathway that accelerates patient access to highly…
On 20 March 2026, the European Commission adopted two Delegated Regulations1 that will expand the list of well-established technologies referred to in Regulation (EU) 2017/745 on medical devices (MDR), with a view to exempting them from some legal requirements and…
The European Commission has updated its question-and-answer style guidance1 on the obligations to inform in case of interruption or discontinuation of supply of certain devices. It has also published a decision tree2 to help manufacturers of medical devices assess the…
In April 2026, the first revision of Medical Device Coordination group guidance MDCG 2021-24 Rev.1, Guidance on classification of medical devices, was released1. The changes made in this latest version affected the following sections: 1 General requirements (updated); 1.4…
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…
In April 2026, the fifth version of the Manual on borderline and classification for medical devices under Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices was published1. This document presents the borderline…
The recently published EN IEC 60601-2-57:2026, Medical electrical equipment – Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring, cosmetic and aesthetic use, specifies essential safety and performance…
Commission Implementing Decision (EU) 2026/193 of 28 January 20261 amends the Annex to Implementing Decision (EU) 2021/1182, which lists the references of harmonised standards drafted in support of Regulation (EU) 2017/745 (MDR). Commission Implementing Decision (EU) 2026/193 adds the following…
An announcement was made by the Egyptian Drug Authority to representatives of companies importing medical supplies, equipment, and diagnostic reagents regarding accreditation procedures in accordance with European regulations for medical supplies and diagnostic reagents1. If a company wishes to rely…
The Egyptian Drug Authority (EDA), represented by the Central Administration of Medical Devices, has announced1 the facilitation of the following registration procedures for medical devices: Registration samples. The sample is requested from the company for review by the Scientific…
Reporting on nomenclature and coding is now a mandatory requirement for the marketing of medical devices and in vitro diagnostic reagents in Colombia, following the end of the transition period established by the National Institute for Food and Drug Surveillance…
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.…
A Notice regarding matters relating to the pre-review of clinical trial protocols for innovative medical devices was issued by the Center for Medical Device Evaluation on 13 March 20261. This initiative allows applicants developing innovative devices to request a pre-review…
On 13 March 2026, the following two medical device industry standards were repealed1: YY/T 0605.8-2007, Surgical Implants – Metallic Materials – Part 8: Forged Cobalt-Nickel-Chromium-Molybdenum-Tungsten-Iron Alloys; YY/T 0728-2009, Surgical Implants – Use of the Terms ‘Eversion’ and ‘Inversion’ in…
In the event of a discrepancy between the country of origin stated in the marketing certificates and the country indicated on the invoices and labels, the provisions of Regulation (EU) No 952/2013 (European Union Customs Code) shall apply to items…
The Egyptian Drug Authority has announced a simplification to the technical file requirements for locally manufactured medical supplies1. Local manufacturers holding a European CE Certificate are permitted to submit registration (or re-registration) files without needing to submit the following documents:…
In April 2026, use of the regulatory enrolment process (REP) became mandatory for medical devices (version 4.0.0)1. The REP facilitates the filing and processing of regulatory information relating to the company, the dossier and product, the regulatory activity, and the…
The following Guiding Principles1 have been issued by the National Medical Products Administration’s Center for Medical Device Evaluation: Guiding Principles for the Registration Review of Intravascular Ultrasound Diagnostic Equipment (13 April 2026); Guiding Principles for the Registration Review of…
New guidance1 has been issued by Health Canada to outline the regulatory framework for imposing and amending terms and conditions (T&Cs) on medical device licences. The guidance provides direction to both licence holders and Health Canada staff on the application…
Guidance on clinical evidence requirements for medical devices (April 2026) provides updated advice to manufacturers of Class II, III and IV medical devices and regulatory representatives on the clinical evidence requirements for medical devices1. Guidance is provided on when clinical…
In April 2026, Health Canada published new guidance aimed at helping medical device manufacturers comply with key provisions of the Medical Devices Regulations relating to post-market oversight1. The document, entitled Guidance on summary reports and issue-related analyses for medical devices,…
Updated pre-market guidance1 for manufacturers of machine learning-enabled medical devices (MLMDs) was released by Health Canada in April 2026 to set out expectations for licence applications and amendments under the Medical Devices Regulations. The guidance applies to Class II, III…
Health Canada has published updated guidance to help manufacturers interpret the term ‘significant change’ under the Medical Devices Regulations and determine when a licence amendment is required1. The guidance focuses on Class III and IV medical devices, outlining when proposed…
Health Canada has revised the classification1 of COVID-19 testing devices under the Medical Devices Regulations, reflecting changes in scientific evidence, disease risk profile and the broader public health context since the COVID-19 pandemic. During the pandemic, SARS-CoV-2 was considered a…
Provision 224/2026 from the National Administration of Drugs, Food and Medical Devices (ANMAT) has amended the procedure governing the importation of used and refurbished medical devices1. The new regulations, which replace ANMAT Provision 806/2007, align the health regulations with the…
Provision No. 236/2026 has entered into force, establishing a new, simplified registration procedure for the importation and marketing of certain medical products1. Under this Provision, the submission of a sworn statement (Declaración Jurada) is now required for imported medical products…
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…
Software that meets the definition of a medical device under Section 41BD of the Therapeutic Goods Act 1989 will be regulated by the Therapeutic Goods Administration unless it has been excluded. Excluded products are listed in the Therapeutic Goods (Excluded…
Comments were accepted until 16 January 2026 on a draft guidance entitled, Menstrual Products – Performance Testing and Labeling Recommendations1,2. This draft guidance document provides recommendations for performance testing, labelling, and information for inclusion in pre-market notification (510(k)) submissions, when…
On 2 February 2024, the Food and Drug Administration (FDA) issued the final rule entitled, Medical Devices; Quality System Regulation Amendments (the Quality Management System Regulation (QMSR) Final Rule). This rule amended the device current Good Manufacturing Practice (cGMP) requirements…
