Introducción El uso de los dispositivos médicos para la prevención, el diagnóstico y el tratamiento de enfermedades o problemas físicos, el alivio de síntomas o la contracepción; los convierte en un elemento indispensable para los servicios de salud. Su diversidad…
On 3 February 2026, the Medical Device Authority (MDA) became1 a participating national regulatory authority in the World Health Organization (WHO) Collaborative Registration Procedure for WHO prequalified in vitro diagnostics (IVDs). This reliance-based regulatory mechanism is designed to facilitate and…
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…
Introduction The use of medical devices for the prevention, diagnosis, and treatment of diseases or physical problems, symptom relief, or contraception makes them an indispensable element of healthcare services. Their diversity and widespread use require an appropriate regulatory system to…
On 12 January 2026, updates were made to the guidance on submitting an application for approval of a clinical trial that includes an in vitro diagnostic device (IVD)1. This update has clarified the documentation requirements where the device is not…
A new roadmap was published on 15 December 2025 to set out deliverables and timelines to support the development of safe in vitro diagnostic (IVD) medical devices1. The roadmap outlines broad timelines and deliverables for 2026 and 2027 across three…
The Council of Ministers has approved the text of the new Royal Decree on in vitro diagnostic medical devices (IVDs)1. This new Decree complements Regulation (EU) 2017/746, which established a new regulatory framework for IVDs with the aim of guaranteeing…
Revisions of several guidance documents were published in October 2025: GN-34: Guidance Document for IVD Analysers1 The second revision of GN-34 provides updated guidance to product owners and registrants concerning in vitro diagnostic (IVD) analysers and their associated accessories.…
MedTech Mitra’s In-Vitro Diagnostic [IVD] Innovators Handbook1 has been developed to support stakeholders involved in the development and evaluation of IVDs, including manufacturers, developers, regulators, healthcare providers, and academic researchers. The handbook addresses the complex requirements associated with IVD development…
Medical devices must bear the CE marking to be marketed within the European Union. However, in certain specific cases provided for by the Regulations, the French National Agency for Medicines and Health Products Safety (ANSM) may exceptionally grant a derogation…
During an emergency, appropriately safe and effective in vitro diagnostic (IVD) tests are critical to the diagnosis, treatment, tracking, and interruption of transmission of infectious diseases during outbreaks, as well as for diagnosing and treating diseases or conditions caused by…
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…
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…
On 16 October 2025, the Therapeutic Goods Administration published on its website Guidance on the regulatory framework for in vitro diagnostic (IVD) companion diagnostics (CDx) and for the medicine or biological that requires CDx testing1. The purpose of this guidance…
The UK government has announced its intention1 to amend the Medical Devices Regulations 2002 for Great Britain to incorporate European Union Common Specifications for high-risk in vitro diagnostics (IVDs) and to repeal regulations on Coronavirus Test Device Approvals (CTDA). Respondents…
MDCG 2025-5, Questions & Answers Regarding Performance Studies of In Vitro Diagnostic Medical Devices under Regulation (EU) 2017/746, was published in June 20251. This document is intended to provide guidance to sponsors of performance studies of in vitro diagnostic medical…
Guidance on the regulatory framework for in vitro diagnostic (IVD) companion diagnostics (CDx) and for the medicine or biological that requires CDx testing has been updated1. The title of the guidance has been changed from Complying with rules for IVD…
The Medical Devices (Amendment) (Great Britain) Regulations 2025 will come into force on 24 May 2025 to provide continuity in the regulation of medical devices by maintaining the regulatory status quo1. These Regulations extend to England, Wales, Scotland and Northern Ireland, but…
Licensing of in vitro diagnostics (IVDs) under the Medical Devices Rules, 2017 requires a detailed evaluation protocol for the performance evaluation of IVDs to evaluate their quality and performance. To facilitate this process, the Indian Council of Medical Research (ICMR)…
The In Vitro Diagnostic (IVD) Expert Panel has provided new scientific advice on SARS-CoV-2 to the Medical Device Coordination Group (MDCG)1, clarifying that while the virus can still cause serious illness, it no longer poses a life-threatening risk with a…
The rule on the health classification of ultrasensitive C-reactive protein (CRP) tests has been revised and, as a result, the classification of these devices has been changed from risk Class III to risk Class II1. The classification rules that regulate…
Interested parties have until 23 May 2025 to submit comments on proposed changes to the classifications and definitions for in vitro diagnostic medical devices (IVDs)1. The consultation aims to confirm views on aligning Australia’s classification rules, principles, and definitions with…
Interested parties have until 10 March 2025 to submit comments on the draft guidance entitled, Validation of Certain In Vitro Diagnostic Devices for Emerging Pathogens During a Section 564 Declared Emergency, to ensure that the Agency considers those comments before…
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 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…
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 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…
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…
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 Therapeutic Goods (Medical Devices – Information that Must Accompany Application for Inclusion) Amendment Determination (No. 3) 20241 was published on 13 December 2024 to amend the Therapeutic Goods (Medical Devices – Information that Must Accompany Application for Inclusion) Determination…
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…
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…
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…
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…
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…
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 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…
On 4 September 2024, Collegiate Board Resolution (RDC) No. 848/2024 came into force, replacing RDC No. 546/20211,2. The new Resolution updates the essential safety and performance requirements applicable to medical devices and in vitro diagnostic medical devices (IVDs) in line…
A final rule1, which was published on 6 May 2024 and became effective on 5 July 2024, amends the Food and Drug Administration’s (FDA’s) regulations to make it explicit that in vitro diagnostic medical devices (IVDs) are devices under the…
Comments were solicited by the Medicines and Healthcare products Regulatory Agency (MHRA) on the inclusion of Common Specification requirements in the Medical Devices Regulations 2002 that would need to be met by certain high-risk in vitro diagnostics (IVDs) before they…
The Norwegian Medical Products Agency recently held a public consultation1 on a proposal for the implementation into Norwegian law of Commission Implementing Regulation (EU) 2023/2713 on the designation of European Union reference laboratories for in vitro diagnostic medical devices. The…
A new Guide for Health Institutions that Manufacture and Use In-house In Vitro Diagnostic Medical Devices in Ireland (SUR-G0052-1) has been published by the Health Products Regulatory Authority (HPRA)1. This guide provides an overview of the legislation and key concepts…
A third revision of Medical Device Coordination Group (MDCG) 2020-16, Guidance on Classification Rules for In Vitro Diagnostic Medical Devices under Regulation (EU) 2017/746, was published in July 20241. This latest update adds the following definition for a kit: ‘a…
On 9 July 2024, Regulation (EU) 2024/1860 was published in the Official Journal1 to implement a gradual rollout of the EUDAMED database, introduce an obligation to inform in case of interruption or discontinuation of supply, and set new transitional provisions…
The State Institute for Drug Control’s Medical Device Regulation Section has published Methodological Recommendations for the Implementation of IVDR [In Vitro Diagnostics Regulation] Requirements for In Vitro Diagnostic Medical Devices Manufactured and Used Only Within a Healthcare Facility1 (i.e. in-house…
Version 3.0 of the guidance on the regulatory requirements for in-house in vitro diagnostic medical devices (IVDs) was published by the Therapeutic Goods Administration on 1 May 20241. This guidance is intended to support Australian laboratories that manufacture in-house IVDs…
In May 2024, an updated version of the Classification Catalogue of In Vitro Diagnostic [IVD] Reagents was published1–3 and this version will become effective on 1 January 2025. The IVD reagents included in the Classification Catalogue refer to IVD reagents…
On 15 April 2024, the Medical Device Coordination Group (MDCG) released MDCG 2024-4, Safety reporting in performance studies of in vitro diagnostic medical devices under Regulation (EU) 2017/7461. This document defines serious adverse event reporting modalities and includes a summary…
