The Medicines and Healthcare products Regulatory Agency’s guidance page on clinical investigations for medical devices1 has undergone numerous updates over the past couple of months. In August 2025, the wording in the ‘Payment for a clinical investigation’ section was revised…
In September 2025, the Standardised format for post-market surveillance report (PMSR)1 was published to guide manufacturers on what data to include within a PMSR in accordance with The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024. It is…
New guidance on clinical trials conducted in Great Britain that include an in vitro diagnostic device (IVD) was published1 by the Medicines and Healthcare products Regulatory Agency (MHRA) on 1 October 2025. IVDs, including companion diagnostic devices, may be used in…
From 1 April 2026, Regulation 53 of the UK Medical Devices Regulations 2002 will introduce a new annual fee and updated fee structure that will apply for the financial year 2026–271,2. The key changes to fees and charges are as…
On 5 September 2025, the Ministry of Public Health issued a draft Announcement1 on the criteria, methods, and conditions for preparing and maintaining records and reports on the production, import, or sale of medical devices. The draft Announcement will take…
To assist holders of medical device licences or notifications who face difficulties renewing their licences, the Food and Drug Administration has announced1 that certain information, documents, or evidence may be exempt from submission at the time of renewal, as necessary…
An Announcement has been issued by the Ministry of Public Health concerning advertisements for medical devices in national academic exhibitions or international or academic conferences that do not require permission (B.E. 2568)1. The Announcement defines ‘national or international academic exhibition’…
An amended version of the Technical Guidelines for Inspection and Registration of Computer-Assisted Detection (CADe) and Computer-Assisted Diagnosis (CADx) Medical Devices Using Artificial Intelligence/Machine Learning Technologies was published in August 20251. These updated guidelines provide industry stakeholders with a reference…
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…
Swissmedic has adopted1, with immediate effect, the new European Union (EU) requirements for the electronic provision of instructions for use for medical devices as provided for by Commission Implementing Regulation (EU) 2025/1234 of 25 June 2025 amending Implementing Regulation (EU)…
The Ministry of Health is preparing a Digital Health Bill to regulate the use of big data in research and clinical trials1. The future law will ensure that all citizens, both in the public and private sectors, have access to…
The Spanish Agency for Medicines and Medical Devices (AEMPS) has published a memorandum1 that establishes the basis for collaboration and communication between the AEMPS – as the Competent Authority for medical devices and in vitro diagnostics (IVDs) – and the…
The second revision of GL-08, Regulatory Guidelines for Laboratory Developed Tests (LDTs), was released in September 20251. This document provides guidance and clarity to clinical laboratories on the regulatory requirements applicable to LDTs under the Health Products Act 2007 and…
In September 2025, the fifth revision of GN-35, Guidance on Special Access Routes (SAR), was issued1. Under the Health Products Act and the Health Products (Medical Devices) Regulations 2010, all Class B, C and D medical devices are required to be…
A public consultation has been held on the document Draft Financial Agreement – Clinical Research on Medical Devices1, an initiative launched by the Working Group for the Promotion of Clinical Research on Medical Devices in Portugal, which includes representatives from…
Implementation of Administrative Order No. 2024-0016, Implementing Guidelines on the New Schedule of Fees and Charges of the Food and Drug Administration1, had been temporarily suspended for a period of 60 working days to allow the Food and Drug Administration…
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…
Circular Letter of the Medical Device Authority No. 2 of 2025, Policy on Implementation and Enforcement under the Medical Device Act 2012 [Act 737]: Conformity Assessment Procedures for Medical Device Approved by Recognised Countries1, took effect on 30 September 2025,…
The second edition of MDA/GD/0070, Establishment Guide to Medical Device Registration Submission in MeDC@St Through Conformity Assessment by Way of Verification Process for Class A Medical Device Submission and for Class B, C, and D Medical Device Submission via Conformity…
The second edition of MDA/GD/0068, Conformity Assessment Body (CAB) Guide for Conducting Conformity Assessment by Way of Verification, was released in September 20251. This guidance document sets out the requirements for the verification process for Class B, C and D…
The seventh edition of the guidance document Requirements for Labelling of Medical Devices has been drafted and circulated for public comment1. This draft guidance updates and clarifies the requirements for medical device labelling, particularly the inclusion of electronic labelling requirements…
A draft guidance document entitled, Application for Confirmation Status of Obsolete and Discontinued Medical Device, has been circulated for public comment1. This draft guidance document specifically outlines the eligibility criteria, application procedures, and the responsibilities and obligations of establishments when…
The Medical Device Authority (MDA) has been officially recognised as an Affiliate Member of the Medical Device Single Audit Program (MDSAP) by the MDSAP Regulatory Authority Council with effect from 16 September 20251. With this recognition, the MDA will begin…
The Medical Device Authority has published a guidance document for comment entitled, Application for Confirmation Status of Orphaned Medical Device1, which outlines the eligibility criteria, application procedures, and the responsibilities and obligations of healthcare facilities when managing orphaned medical devices.…
The Medical Device (Amendment) Regulations 2025 have been published1 and will come into operation on 1 January 2026. These new Regulations amend the Fifth Schedule to the Medical Device Regulations 2012 to restructure the fees charged for the registration of…
In August 2025, the Pharmaceuticals and Medical Devices Agency (PMDA) posted on its website1 items that should be checked before applying for a general medical device consultation. Anyone wishing to enquire about whether a product under development is a medical…
Two Ministerial Decrees of 7 August 2025 – which define the new fee rates for services offered by the Ministry of Health relating to the medical device1 and in vitro diagnostic (IVD)2 sectors – entered into force on 26 September…
The fourth edition of ISO 7405:2025, Dentistry – Evaluation of biocompatibility of medical devices used in dentistry, has been issued1. ISO 7405 provides a set of biological test methods to evaluate the biocompatibility of medical devices used in dentistry. These…
Comments were accepted until 31 October 2025 on the proposed fees for 2026 for medical device related activities conducted by the Health Products Regulatory Authority (HPRA)1. A general fee increase of 2.5% has been proposed. It has also been proposed…
The showcase of drugs, medical devices, and health service support equipment in version 5 of the Electronic Catalogue ended on 30 September 2025, and version 6 of the Electronic Catalogue became active on 1 October 20251. Drugs, medical devices, and…
The first batch of standard in vitro diagnostic medical device (IVD) evaluation protocols has been released by the Indian Council of Medical Research (ICMR) and the Central Drugs Standard Control Organisation (CDSCO) for use by IVD manufacturers’ testing laboratories1. Licensing…
A draft Guidance Document on Medical Device Software1 has been circulated for stakeholder comment. The purpose of this document is to provide guidance to Indian manufacturers and importers for the submission of an application to the Licensing Authority to obtain…
Comments are being solicited until 8 December 2025 on a proposed document from the International Medical Device Regulators Forum (IMDRF) entitled, Essential Principles and Content of Predetermined Change Control Plans1. The purpose of this document is to share high-level principles…
Guidance document GN-00, Guidance on Definitions and Abbreviations in the Administrative System for Medical Devices, was updated on 2 October 2025 with immediate effect1. The latest change modified Section 2.42.3 to read as follows: ‘Adaptable medical device means a…
A new Technical Reference document TR-008, Artificial Intelligence Medical Devices, was published on 2 October 2025 to set out definitions and listing requirements for artificial intelligence (AI) medical devices1. According to TR-008, the information on AI medical devices specified in…
A new Technical Reference document TR-007, Medical Device Software and Cybersecurity, was published on 1 September 20251. This document provides an overview of software developed for medical purposes, the concepts and principles for the classification of medical device software under…
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…
The Finnish Medicines Agency (Fimea) has published1 a new online tool that allows operators to assess whether they are covered by national cybersecurity legislation in accordance with the European Union’s Directive (EU) 2022/2555 on measures for a high common level…
The European Union’s (EU’s) Regulation (EU) 2024/1689 laying down harmonised rules on artificial intelligence (the AI Act)1, as well as Finland’s complementary national legislation (HE 46/2025)2, impose new obligations on the Finnish Medicines Agency (Fimea) regarding the supervision of AI…
Commission Implementing Regulation (EU) 2025/2086 was published on 20 October 20251 to set out the procedural rules for the interaction during, exchange of information on, and participation in, the preparation and update of joint clinical assessments of medical devices and…
At the Medical Device Coordination Group (MDCG) plenary meeting on 24 September 2025, the European Commission presented an updated status of the development of EUDAMED1. The new timetable means that mandatory use of the first four modules – Actor, UDI/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…
In September 2025, the fourth 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…
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…
Commission Implementing Decision (EU) 2025/20781 amends the Annex to Implementing Decision (EU) 2021/1182 with respect to harmonised standards for surgical clothing and drapes, medical face masks and sterilisers for medical purposes. Implementing Decision (EU) 2021/1182 lists the references of harmonised…
On 18 August 2025, the Central Administration for Pharmaceutical Policies and Market Support and the Central Administration for Medical Supplies issued a regulatory guide1 on the rules and procedures governing the import and export of samples of medical supplies, laboratory…
Comments are being sought on a partial amendment1 of the Sanitary Technical Regulations for obtaining a certificate indicating whether or not health registration, a health notification or a mandatory health notification is required for products for human use and consumption…
The Danish Medicines Agency has expanded the regulatory advice it offers1 to include advice on the European Union’s (EU’s) Regulation (EU) 2024/1689 laying down harmonised rules on artificial intelligence (the AI Act). Start-ups, small to medium sized enterprises and educational/research…
Comments are being accepted until 4 November 2025 on the following draft standards: National Standard of the People’s Republic of China, Implants for surgery – Metallic materials – Part 1: Wrought stainless steel1 This document specifies the performance requirements and…
A period of public consultation has been held on draft Regulations on the Filing and Management of Internet Drug and Medical Device Information Services1. The purpose of these Regulations is to standardise the filing of Internet drug and medical device…
