The blood collection device for cell-free nucleic acids – which is intended for medical purposes to collect, store, transport and handle blood specimens and to stabilise and isolate cell-free nucleic acid components prior to further testing – has been classified…
Technical information report (TIR) 109 is being developed by the Association for the Advancement of Medical Instrumentation (AAMI) to define best practices for ensuring packaging integrity during transportation of sterile medical devices1. The new guidance document is expected to be…
On 21 October 2024, the draft post-market surveillance Statutory Instrument was laid in Parliament1. The new regulations will introduce clearer and more robust requirements for post-market surveillance that should improve patient safety. The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great…
Interested parties had until 24 October 2024 to submit comments on proposals to amend the Medicines and Healthcare products Regulatory Agency’s (MHRA’s) statutory fees1. The proposed implementation date for these changes is 1 April 2025. With respect to medical devices,…
On 30 September 2024, the third revision of the Guideline on the Implementation of the Regulation on the Sale, Advertising and Promotion of Medical Devices was published1. Issues regarding the technical service activities and warranty certificate within the scope of…
The provisions of Regulation (EU) 2023/607 amending the transitional provisions of certain medical devices and in vitro diagnostic medical devices contained in Regulations (EU) 2017/745 and 2017/746 have been implemented in Turkey in line with the European Union Member States.…
The first module of swissdamed – the Swiss database for registering economic operators and medical devices, including in vitro diagnostics, on the Swiss market – went live on 6 August 20241. This first module (the Actors module) enables economic operators…
The Spanish Agency for Medicines and Medical Devices (AEMPS) has just published the results of a survey1 it conducted of Spanish manufacturers of in vitro diagnostic products (IVDs), between 5 December 2023 and 31 January 2024, to evaluate their level of implementation…
Interested parties had until 21 October 2024 to submit comments on a draft Guidance on Change Management Program (CMP) for SaMD [software as a medical device]1. The draft guidance outlines the Health Sciences Authority’s new optional regulatory pathway – the…
An amendment1 to Administrative Order (AO) 2013-0031, Requirements for the Operation of Therapeutic X-ray Facility Utilizing Medical Linear Accelerators has been proposed to address the non-compliance of most therapeutic x-ray facilities with the manpower requirements and to accommodate dedicated radiation…
The Food and Drug Administration (FDA) is currently developing the FDA eServices Portal System – an online platform for, initially, a streamlined initial application of a Certificate of Medical Device Notification (CMDN)1. An implementation pilot for submitting initial CMDN applications…
A Regulation has been proposed for the registration, control and sanitary surveillance of in vitro diagnostic medical devices (IVDs), including their accessories, in order to ensure the protection of public health1. The provisions contained in this proposed Regulation will be…
Medsafe, the New Zealand Medicines and Medical Devices Safety Authority, has been seeking feedback on proposed updates to the Guideline on the Regulation of Therapeutic Products in New Zealand: Clinical Trials1 and, among others, a new document entitled, Clinical Trial…
Comments have been sought on the draft Mexican Official Standard PROY-NOM-240-SSA1-2024, Installation and operation of technovigilance1, which aims to guarantee the protection of patient health, as well as the safety of medical devices marketed and used in Mexico. The purpose…
A period of public consultation has been held on draft Mexican Official Standard PROY-NOM-241-SSA1-2024, Good Manufacturing Practices for Medical Devices1. The purpose of this draft standard is to establish the minimum requirements for the processes of design, development, manufacturing, storage…
The Medical Device Authority has confirmed1 that it will allow expired EC Certificates pursuant to Directive 90/385/EEC, Directive 93/42/EEC, or Directive 98/79/EC, as well as Declarations of Conformity pursuant to Directive 98/79/EC (only applicable to Class B in vitro diagnostics…
In October 2024, the Pharmaceutical and Medical Device System Subcommittee issued proposals1–3 for amendment of the Pharmaceuticals and Medical Devices Act (PMD Act) with respect to, among other things, streamlining the registration and certification process for medical devices. For in…
On 8 August 2024, a Memorandum of Understanding was signed1 to confirm the collaboration between the Ministry of Health and all the actors involved and identified by Italy’s National Plan for the elimination of the use of dental amalgam. The…
On 19 September 2024, the following three voluntary standards concerning ophthalmic optics were published and entered into force: SI 798-1, Ophthalmic Optics – Uncut Finished Spectacle Lenses – Part 1: Specifications for single-vision and multifocal lenses1; SI 798-2, Ophthalmic…
Comments were accepted until 30 October 2024 on the proposed fees for 2025 for medical device related activities conducted by the Health Products Regulatory Authority (HPRA)1. A general fee increase of 5% has been proposed. It has also been proposed…
New guidance (SUR-G0053-1) has been issued1 in the form of a frequently-asked-questions document to explain to in-house manufacturers of medical devices and in vitro diagnostic medical devices (IVDs) about the requirement to notify the Health Products Regulatory Authority of their…
Circular Letter No. HK.02.02/E/1753/20241 concerns the implementation of Good Distribution Practice (GDP) certificates for medical devices as a requirement for listing in Indonesia’s electronic catalogue system. This Circular Letter clarifies that every distributor of medical devices is required to have…
On 6 September 2024, the Department of Pharmaceuticals issued a Uniform Code for Marketing Practices in Medical Devices (UCMPMD) 20241 to all medical device industry associations; strict compliance with this Code is expected by all member companies. All medical device…
In August 2024, updates were made to the following guidance documents: GN-01, Overview of the Medical Device Administrative Control System (version 6.1)1 Amendments were made to Sections 3.2.1.1 to 3.2.1.4 (Scope of Medical Device Administrative Control System), Section 5.5…
From 1 January 2025, the Medical Device Division will not process renewal applications for scheduled medical devices that arrive at the Division less than 12 weeks before the scheduled expiration date1. The Local Responsible Person must submit the renewal application…
In August 2024, changes were made to the following five Codes of Conduct: COP-01, Code of Conduct for Local Responsible Persons (version 3)1 Sections 4.2 to 4.2.4 (Appeals) have been amended and Section 4.2.5 has been added. COP-02, Code…
The Expedited Approval Scheme for Medical Device Listing Applications has been extended to include Class B/C/D in vitro diagnostic medical device (IVD) listing applications with effect from 26 July 20241. The purpose of the Expedited Approval Scheme is to streamline…
On 14 August 2024, Rule 14 of Section 7.1 of Technical Reference TR-003, Classification of General Medical Instruments, was updated1. According to Rule 14, all devices manufactured from or containing animal or human cells/tissues/derivatives (whether viable or not) are classified…
Comments have been solicited on the following draft guidance documents prepared by the Global Harmonization Working Party (GHWP) ahead of its 28th annual meeting in December 2024: GHWP/WG7/PD002:2024, Guidance Document for Medical Device Organisations – Product Localisation for Manufacturing…
As part of ongoing monitoring of medical devices containing cobalt, the National Agency for the Safety of Medicines and Health Products (ANSM) has established a dedicated, temporary scientific committee to evaluate medical devices containing cobalt (implants and prostheses)1. This scientific…
The first revision1 of MDCG 2021-4 has been published to provide updated guidance on the application of the transitional provisions for the certification of Class D in vitro diagnostic medical devices (IVDs) according to Regulation (EU) 2017/746 (IVDR). According to…
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…
Commission Implementing Regulation (EU) 2024/2699 of 18 October 20241 sets out detailed procedural rules for the cooperation of the Member State Coordination Group on Health Technology Assessment and the European Commission with the European Medicines Agency in the form of…
In October 2024, the Medical Device Coordination Group (MDCG) released new guidance entitled, Guidance on qualification of in vitro diagnostic medical devices (MDCG 2024-11)1. This guidance document clarifies which products fall within the scope of Regulation (EU) 2017/746 on in…
MDCG 2024-12, Corrective and preventive action (CAPA) plan assessment: guidance and templates for conformity assessment bodies, notified bodies, designating authorities and joint assessment teams, was released by the Medical Device Coordination Group (MDCG) in October 20241. This guidance document provides…
The first update of Medical Device Coordination Group (MDCG) guidance MDCG 2021-25 Rev. 1, Regulation (EU) 2017/745 – application of MDR requirements to ‘legacy devices’ and to devices placed on the market prior to 26 May 2021 in accordance with…
The five-part EN ISO 18113 series has been published to set out key requirements that manufacturers must provide for information accompanying in vitro diagnostic medical devices (IVDs), including the product label and instructions for use. Specific parts in the standard…
In August 2024, the European Medicines Agency (EMA) launched a pilot programme to support the development and assessment of orphan medical devices in the European Union (EU)1. The pilot programme offers free advice from the medical device expert panels to…
In late August/early September 2024, feedback was sought on a proposed Commission Implementing Regulation1 to amend Implementing Regulation (EU) 2022/1107, which sets out the Common Specifications for certain Class D in vitro diagnostic medical devices (IVDs). For Class D devices…
The European Artificial Intelligence Act (AI Act) – the world’s first comprehensive regulation on AI – entered into force on 1 August 20241. The AI Act is designed to ensure that AI developed and used in the European Union (EU)…
Commission Implementing Decision (EU) 2024/2631 of 8 October 20241 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) 2024/2631 adds the following…
The Estonian Board of Health has updated its procedure for processing conformity assessment exemptions for medical devices and has developed two new application forms1,2. The Board of Health, which is the Competent Authority in Estonia, may exceptionally, on the basis…
The Egyptian Drug Authority has published procedures for local factories to follow to import fully manufactured samples of medical and laboratory supplies and devices, and laboratory and diagnostic reagents, for non-commercial purposes (i.e. research and development, validation or evaluation, reverse…
The Egyptian Drug Authority has published details of a mechanism for handling changes mentioned in the letters extending the deadline issued by a European Notified Body granting quality certificates where those changes are not documented in the medical device’s registration…
On 8 October 2024, a new Guideline for Preclinical Testing and Clinical Investigation for Medical Devices (EDREX.GL.Bioinn.010) was published by the Central Administration of Biological and Innovative Products and Clinical Studies and entered into force with immediate effect1. This document…
On 22 September 2024, the Egyptian Drug Authority announced1 that with regard to the registration files for sterile parts of imported dental implants that have obtained an initial acceptance number from the General Administration of Registration at the Central Administration…
The Danish implementation of the NIS 2 Directive – Directive (EU) 2022/2555 on measures for a high common level of cybersecurity across the Union – has been postponed until 1 March 20251. This European Directive replaces the previous NIS 1…
The National Technical Responsible Unit for Clinical Evaluation Standardisation of Medical Devices has drafted the following two industry standards1: Terminology and Definitions for Real-World Data of Medical Devices; Biological Sample Management Requirements for Clinical Trials of In Vitro Diagnostic…
The Center for Medical Device Evaluation (CMDE) has selected1 typical products from among the following product types recommended for clinical trials: passive implantable devices; neurological and cardiovascular surgical devices; dental devices; radiotherapy devices; medical imaging devices; and medical diagnostic…
Comments were accepted until 30 August 2024 on a proposed update1 to the Catalogue of Medical Devices Exempted from Clinical Evaluation, which was last published in 20232. The currently-in-effect catalogue contains 1025 medical device types, of which 821 are Class…
