The Food and Drug Administration (FDA) has updated its ‘Recognized Consensus Standards’ database (List 63)1, which includes, among other changes, three newly recognised standards for medical device sterilisation and interoperability: ISO 11737-3, Sterilization of health care products – Microbiological…
The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 20241 amend the UK’s Medical Devices Regulations 2002 by inserting a new Part 4A on post-market surveillance (PMS) requirements for medical devices, including in vitro diagnostic medical devices (IVDs) and…
On 14 November 2024, the Medicines and Healthcare products Regulatory Agency (MHRA) published a consultation1 on routes to market and in vitro diagnostic devices (IVDs) in Great Britain; the consultation closed on 5 January 2025. The consultation document focused on…
A fourth revision of the Guide on the Implementation of the Medical Device Sales, Advertising and Promotion Regulation (TCS-KLVZ-08) was published on 30 December 20241. Topics addressed in the update include: issuance of warranty certificates; technical service responsibilities; qualification…
At its meeting on 20 November 2024, the Federal Council decided1 to modify the Ordinance on In Vitro Diagnostics (IVDV) to extend the transition periods for the new requirements for in vitro diagnostics (IVDs) in line with European Regulation (EU)…
The Medical Devices Cluster of the Health Sciences Authority (HSA) is piloting its Change Management Program (CMP) for software as a medical device (SaMD), including machine learning (ML)-enabled SaMD1. The CMP is a new, optional regulatory pathway specifically for SaMD…
On 12 December 2024, a Notice was issued1 concerning a list of medical devices (within the Register of Medical Devices) that can be sold at closed sales points where other retail trade is carried out in accordance with the regulations…
In November 2024, Administrative Order No. 2024-15 introduced updated rules, requirements and procedures for initial, renewal and variation Licence to Operate (LTO) applications submitted via the Food and Drug Administration eServices Portal System1. According to this Administrative Order, the following…
Administrative Order No. 2024-0016 (9 December 2024) sets out the new schedule of fees and charges for licensing, registration, and other authorisations and regulatory services performed by the Food and Drug Administration1,2. The fees that apply to medical devices and…
Food and Drug Administration (FDA) Advisory No. 2024-1089-A1 formally announced the conclusion on 29 November 2024 of the pilot implementation of the FDA eServices Portal System for the initial application of a Certificate of Medical Device Notification (CMDN) within the…
Interested parties have until 3 February 2025 to submit comments on the second edition of the guidance document MDA/GD/0066, Importation of Medical Device for Personal Use1. This guidance document has been designed to assist individuals who intend to bring any…
A period of public consultation has been held on a new draft guidance document concerning the control of obsolete and discontinued medical devices in healthcare or related facilities1. In March 2024, the Medical Device (Exemption) Order 2024 went into effect…
The Ministry of Food and Drug Safety (MFDS) has recently issued a raft of legislative proposals pertaining to digital medical products: Enforcement Decree of the Digital Medical Products Act1 The purpose of this proposed Decree is to prescribe matters…
Guidelines for the correct labelling of medical surgical devices were formalised through publication of the Decree of the Director General of 17 December 20241. These guidelines have been designed to help protect the health of the consumer and the professional…
The Directorial Decree of 29 March 20231 provided for a progressive revocation of the marketing authorisations for intact skin disinfectant products as medical surgical devices prior to medical treatment, as this type of activity no longer falls under the medical…
On 31 December 2024, the administrative extension of validity granted to registration certificates in the Medical Equipment Register (AMR certificates) expired1, affecting: medical equipment registered in the Register where the validity of the registration certificate expired between 1 December…
A new mandatory Israeli Standard, SI 1147, The elastic properties of flat, non-adhesive, extensible fabric bandages1, is set to replace mandatory standards SI 1147, SI 1147-1, SI 1147-2 and SI 1147-3. The newly-proposed SI 1147 would adopt the British Standard…
International Workshop Agreement (IWA) 48:2024, Framework for implementing environmental, social and governance (ESG) principles (Edition 1), was published in November 2024 by the International Organization for Standardization (ISO)1. Its development was a collaborative effort by national standards bodies including the…
A guidance document has been published1 on the validation of rapid diagnostics for pathogen identification and antimicrobial susceptibility testing. This guidance specifies a comprehensive framework to evaluate and confirm systematically the diagnostic performance of a given test, ensuring its reliability…
A period of public consultation has been held1 on proposed updates to the medical device classification lists for interventional radiology, radiotherapy, oncology, and Class A (non-sterile and non-measuring) medical devices. The existing classification lists for these categories of medical devices…
Interested parties have until 15 February 2025 to submit comments on the in vitro diagnostic medical device (IVD) evaluation protocols drafted by the Indian Council of Medical Research (ICMR) and the Central Drugs Standard Control Organisation (CDSCO) for use by…
A new Decree on the fees charged by the Finnish Medicines Agency (Fimea) has been published1 to replace Ministry of Social Affairs and Health Decree 1282/20232. The new Decree took effect on 1 January 2025 and is expected to remain in…
Regulation (EU) 2025/40 of the European Parliament and of the Council of 19 December 2024 on packaging and packaging waste, amending Regulation (EU) 2019/1020 and Directive (EU) 2019/904, and repealing Directive 94/62/EC, was published in the Official Journal on 22…
The European Chemicals Agency (ECHA) and authorities from Denmark, Germany, the Netherlands, Norway and Sweden have released a progress update on the process to restrict per- and polyfluoroalkyl substances (PFAS) in Europe, opening up possible exceptions in the area of…
The ‘COMBINE’ programme strategy was published1 in December 2024 to clarify the vision, the structure and governance, overall plan of activities, the ways of working and approach to evaluation of the activities in the second phase of COMBINE. Member States’…
In January 2025, minor changes have been introduced to MDCG 2023-3, Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 and Regulation (EU) 2017/746, via a second revision1: Question 1, Footnote 8 has…
The Medical Device Coordination Group (MDCG) has released MDCG 2024-131 to summarise the regulatory status of ethylene oxide (EtO) intended for the sterilisation of single-use medical devices during their manufacturing process, which has been discussed in relation to the Review…
On 12 January 2025, Regulation (EU) 2021/2282 on health technology assessment (HTA) became applicable, creating a European Union (EU) framework for the assessment of health technologies (e.g. medical devices) by fostering collaboration and coordination between Member States1,2. The Regulation should help…
Commission Implementing Regulation (EU) 2025/117 was published on 27 January 2025 to set out rules for the application of Regulation (EU) 2021/2282 on health technology assessment with respect to the procedures for joint scientific consultations on medical devices and in…
A minor change was made to Medical Device Coordination Group guidance MDCG 2022-5 Rev. 1, Guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devices in October 20241. Section 1.2.6.1 of the guidance lists…
A question-and-answer style document has been published1 on the practical aspects relating to the implementation of the obligations to inform about interruption or discontinuation of supply of certain devices laid down in Article 10a of Regulation (EU) 2017/745 on medical…
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…
A question-and-answer document has been published1 on practical aspects relating to the implementation of the gradual roll-out of EUDAMED pursuant to Regulations (EU) 2017/745 and 2017/746, as amended by Regulation (EU) 2024/1860. Regulation (EU) 2024/1860 enables a gradual roll-out of…
MDCG 2024-15, Guidance on the publication of the clinical investigation reports and their summaries in the absence of EUDAMED, was published by the Medical Device Coordination Group (MDCG) in November 20241. Article 77(5) of Regulation (EU) 2017/745 on medical devices…
The European Commission has released guidelines1 to facilitate the harmonised application of the provisions on the removability and replaceability of portable batteries and light means of transport (LMT) batteries in Regulation (EU) 2023/1542, which entered into force on 17 August…
A first revision of MDCG 2022-3, Verification of manufactured class D IVDs by notified bodies, was published in December 20241. This Medical Device Coordination Group (MDCG) document aims to provide guidance to Notified Bodies to clarify their role and responsibilities…
A European Parliament Resolution (C/2025/485) on the urgent need to revise Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostics (IVDR) was published in the Official Journal on 29 January 20251. In this Resolution,…
Interested parties have until 21 March 2025 to submit comments on a targeted evaluation1 of Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostics, which has been designed to help the European Commission take stock…
From 1 January 2025, the role of Competent Authority in the field of medical devices will be transferred from the Estonian Health Board to the State Agency for Medicines1. Together with the tasks, people who have been working in the…
The Egyptian Drug Authority has announced1 that as of 10 January 2025, companies wishing to apply to the Scientific Committee and obtain import approvals for medical supplies and devices classified in Class IIb and Class III must commit to submitting…
Comments are being sought on draft Technical Regulations for Health Products and/or Medical Devices1. The purpose of this draft Regulation is to control the manufacture, preparation, quality, supply, circulation, distribution, marketing, information, advertising and promotion, import, export, storage, dispensing, evaluation,…
The National Institute for Food and Drug Surveillance (Invima) is preparing a package of measures that should substantially reduce the time taken to grant health registrations and marketing authorisations, as well as modernise the process1. Part of the strategy is…
In order to further optimise the medical device standard system, the National Medical Products Administration has decided to abolish the following two medical device industry standards1: YY/T 0771.1-2020, Medical Devices of Animal Origin – Part 1: Application of Risk…
Comments were sought until 3 December 2024 on a proposed update to the Catalogue of In Vitro Diagnostic [IVD] Reagents Exempted from Clinical Trials1. This draft document contains 387 IVD reagents, of which 24 are Class III and 363 are…
In response to recent amendments to the Tariff Codes, and the Fee-Charging Standards for Lot Release, Reference Materials, and Testing of Foods, Drugs and Cosmetics, Attachment 1 of Article 3, Attachment 2 of Article 6, and Attachment 3 of Article…
In order to improve the quality and efficiency of the consultation process for technical reviews and correction of medical device registrations, from 2 December 2024, it is now possible to make an appointment for on-site/video consultation instead of an online…
The following draft Guiding Principles have been issued by the Center for Medical Device Evaluation for the purpose of seeking feedback from interested stakeholders1: Guiding Principles for the Registration Review of Changes in In Vitro Diagnostic Reagents (24 January 2025);…
The most recent version of the Classification Catalogue of In Vitro Diagnostic Reagents came into effect on 1 January 2025. To ensure the smooth progress of registration applications for in vitro diagnostic (IVD) reagents, manufacturers should take note of the…
The Fees in Respect of Drugs and Medical Devices Order has been amended to specify the new fees for medical device applications that will apply from 1 April 20251. Details of the fees that will apply from 1 April 2025…
The Regulations Amending Certain Regulations Made Under the Food and Drugs Act (Agile Licensing) amend the Food and Drug Regulations and the Medical Devices Regulations (MDR) to deliver on Health Canada’s modernisation commitments and leverage long-standing policies and practices. They…
