The first revision of Medical Device Coordination Group (MDCG) guidance MDCG 2022-9, Summary of Safety and Performance Template, was issued in April 20241. The guidance is divided into two main sections: Section 1 concerns the Summary of Safety and Performance…
On 21 March 2024, the Medical Devices In Vitro Diagnostic Devices etc. Amendment Regulations 2024 entered into force, introducing provisions required for implementing Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) in Northern Ireland1. These provisions include the…
The Center for Devices and Radiological Health (CDRH) has announced1 its intention to reclassify most in vitro diagnostic medical devices (IVDs) that are currently high risk Class III devices into Class II (moderate risk). These tests are mostly infectious disease…
On 6 March 2024, the National Health Surveillance Agency (Anvisa) approved the proposed standard on the essential safety and performance requirements applicable to medical devices and in vitro diagnostic medical devices (IVDs) and published the final requirements as Resolution RDC…
The Therapeutic Goods Administration (TGA) is soliciting comments on its updated draft guidance document on companion diagnostics (CDx)1. The proposed updates aim to provide sponsors and manufacturers of medicines, biologicals and in vitro diagnostic medical devices (IVDs) with further clarification…
According to the Medicines and Related Substances Act of 2013, applicants should register their medical devices, including in vitro diagnostics (IVDs), with the Botswana Medicines Regulatory Authority (BOMRA) in line with the voluntary and mandatory registration rules outlined below1. …
The first edition of MDA/GD/0065, Placement of HIV Self-Test (HIVST) Kit in Malaysia Market, was published on 19 February 20241. This guidance has been developed to help applicants understand the pre-market, placement on the market, and post-market requirements for human immunodeficiency…
Introduction The date of application for Regulation (EU) 2017/746 on in vitro diagnostics (IVDR) was 26 May 2022; this is when the Regulation came into force with transitional arrangements for different device classes. Before looking at the lessons learnt, it…
Requirements in GCP guidelines and ISO 20916 Conducting a performance evaluation study is a complex process. From the initiation of study procedures to the stage of meeting specific objectives, the study should be subject to close monitoring, which is one…
The European Commission has proposed a new Regulation1 to amend Regulations (EU) 2017/745 (MDR) and (EU) 2017/746 (IVDR) with respect to the gradual roll-out of EUDAMED, a notification obligation in case of interruption of supply, and the transitional provisions for…
On 6 December 2023, Commission Implementing Regulation (EU) 2023/2713 was published, designating five European Union reference laboratories in the field of in vitro diagnostic medical devices (IVDs)1. These reference laboratories will be involved in the conformity assessment of Class D…
Comments were accepted until 26 January 2024 on a draft guide for health institutions who manufacture and use in-house in vitro diagnostic medical devices (IVDs) in Ireland1. The purpose of this guide is to help health institutions and medical laboratories…
Draft Resolution No. 734 of 22 October 2019, which proposed the updating of Resolution RDC No. 36 of 26 August 2015, which establishes the risk classification, control scheme of notification, registration, market authorisation and technical requirements for labelling and usage instructions…
Technical Reference TR-006, In vitro diagnostic medical device classification1, was revised in December 2023 in line with the International Medical Device Regulators Forum’s Principles of In Vitro Diagnostic (IVD) Medical Devices Classification (IMDRF/IVD WG/N64FINAL:2021). Amendments have been made to the following…
The classification lists for in vitro diagnostic medical devices (IVDs) under the provisions of sub-rule (2) of rule 4 of the Medical Devices Rules, 2017 have been updated and supplemented1. The classification list of IVD analysers has been updated and…
In November 2023, the Global Harmonization Working Party (GHWP) finalised and released the following guidance documents: GHWP/WG1-WG2-WG3/F002:2023, Principles of Regulatory Requirements for Electronic Instructions for Use (eIFU)1 GHWP/WG2/F001:2023, Guidance for Additional Considerations to Support Conformity Assessment of In vitro…
Comments are being accepted until 4 December 2023 on a proposed rule to improve the safety and effectiveness of laboratory developed tests (LDTs)1. LDTs are in vitro diagnostic medical devices (IVDs) that the Food and Drug Administration (FDA) has described…
Interested parties have until 20 November 2023 to submit comments to the Global Harmonization Working Party (GHWP) Secretariat (secretariat@ghwp.info) on the following proposed guidance documents: Guidance Document on the Risk-Based Approach to Quality Management System Aspects: ISO 13485:20161 Guidance for…
A third revision of GN-14, Guidance on the Risk Classification of In Vitro Diagnostic Medical Devices, has been released1. In this version, a new definition of standalone software has been added: ‘software and/or mobile application that is intended to function…
Introduction It has become common practice for hospitals or other healthcare institutions to develop their own tests to be used on their own patients, referred to as ‘in-house tests’ or ‘laboratory-developed tests’. In this situation, a healthcare institution manufacturing a…
Regulatory authority State registration is a mandatory procedure necessary for the legal circulation of medical devices in the Republic of Serbia. The following authorities are involved in the approval and marketing of medical devices: Ministry of Health (www.zdravlje.gov.rs) is…
The European Commission’s Comitology Committee has confirmed that draft Common Specifications for certain Class D (highest risk) in vitro diagnostic medical devices (IVDs) will be released soon for public consultation, with adoption by the Commission currently set for the fourth…
In July 2023, guidance was published on the regulation of in vitro diagnostic medical devices (IVDs) in Great Britain1. This guidance summarises the current controls on the sale and supply of IVDs in Great Britain and explains the main features…
Final guidance has been issued to launch a voluntary pilot programme for sponsors of oncology drug products used with certain in vitro diagnostic tests1,2. Under current Food and Drug Administration (FDA) policy, an in vitro companion diagnostic test is one…
Guidance has been released to help sponsors and manufacturers transition to the new manufacturer evidence requirements for in vitro diagnostic (IVD) medical devices1. Manufacturer evidence comprises documents, usually certificates or records of regulatory approval by a comparable overseas regulator, that…
Singapore’s Health Sciences Authority (HSA) has been recognised by the World Health Organization (WHO) as a WHO Stringent Regulatory Authority (SRA) for high-risk Class C and D in vitro diagnostic medical devices (IVDs), making it one of only six regulatory…
During May 2023, a consultation was held on a draft update to GN-14, Guidance on the Risk Classification of In Vitro Diagnostic Medical Devices1. This latest revision includes the following definition for standalone software (also known as software as a…
Regulatory essentials Regulatory authority Directorate of Medicines and Pharmacy (Direction du Médicament et de la Pharmacie, DMP) Classification system Medical devices: Classes I, Im (measuring), Is (sterile), IIa, IIb, III In vitro diagnostic reagents: None Registration requirements Application form, administrative…
A second revision of the Medical Device Coordination Group’s guidance on the classification rules for in vitro diagnostics (IVDs) under Regulation (EU) 2017/746 (IVDR) was published in February 20231. The most significant change was to Rule 3(f) on companion diagnostics…
The Center for Medical Device Evaluation has published a revised version of the classification catalogue for in vitro diagnostic (IVD) reagents1. The period for submitting comments on the proposed revision has now closed. The last list was published in 2013,…
A second revision of the Regulations Governing Registration of Medical Devices including In Vitro Diagnostics has been published1. In this version, in vitro diagnostic medical devices (IVDs) have been added as products regulated under the Regulations, so the Regulations now…
Medical Device Coordination Group documents MDCG 2022-191 and 2022-202 contain templates and other supporting documents that may be used by the sponsor of a performance study under Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). However, it is…
New guidance1 from the Medical Device Coordination Group (MDCG) outlines the activities to be performed by Notified Bodies as part of their ‘appropriate surveillance’, as defined in the last subparagraph of Article 110(3) of Regulation (EU) 2017/746 on in vitro…
MDCG 2021-22 has been updated1 to clarify further the meaning of ‘first certification for that type of device’ and the corresponding procedures to be followed by Notified Bodies with respect to the consultation of the expert panel referred to in…
The replacement reagent and instrument family policy has been updated and clarified in a final guidance document1,2 for manufacturers of in vitro diagnostic devices and Food and Drug Administration staff to promote consistent application of the concepts in the guidance.…
Ministry of Food and Drug Safety (MFDS) Notification No. 2022-371 (23 August 2022)1 proposes amendments to the Enforcement Rule on the Act on In Vitro Diagnostic Medical Devices. If finalised, the changes would eliminate the need for the manufacturer’s address…
Circular No. 05/2022/TT-BYT, dated 1 August 2022, sets out details for the implementation of several Articles of Government Decree No. 98/2021/ND-CP on the management of medical equipment1. The Circular, which took immediate effect: sets rules for the classification and…
Introduction The UK continues to build its position as a sovereign nation, seeking to be a global leader. The medical technology and in vitro diagnostic (IVD) industries may not be on everyone’s radar, but they are critical, underpinning industries of…
Introduction Performance evaluation is defined as an assessment and analysis of data to establish or verify the scientific validity, the analytical performance and, where applicable, the clinical performance of a device. Five years after publication of Regulation (EU) 2017/746 on…
Introduction The regulatory framework for medical devices, including in vitro diagnostic medical devices (IVDs), is the set of provisions that make up the technical, legal and regulatory basis that guarantees the safety, efficacy, performance and effectiveness of these products. This…
Introducción El programa regulador para equipos y dispositivos médicos, incluyendo los dispositivos médicos de diagnóstico in vitro (DMDIV), es el conjunto de disposiciones que forman la base técnica, legal y normativa que garantiza la seguridad, eficacia, desempeño y efectividad de…
Introduction The coronavirus disease (COVID-19) first emerged in Wuhan, China in December 2019, and quickly spread all around the world causing an unprecedented pandemic. The World Health Organization (WHO) quickly released guidance documents for the management of the disease and…
Commission Implementing Regulation (EU) 2022/1107 of 4 July 2022 has been published1 to specify the Common Specifications for certain Class D in vitro diagnostic (IVD) medical devices in accordance with Regulation (EU) 2017/746. To ensure a continuous high level of…
Commission Implementing Regulation (EU) 2022/944 sets out the detailed rules for the application of Article 100 of Regulation (EU) 2017/746 (IVDR) with respect to the tasks of, and criteria for, European Union Reference Laboratories (EURLs) in the field of in…
MDCG 2022-6, Guidance on significant changes regarding the transitional provision under Article 110(3) of the IVDR, has been published by the Medical Device Coordination Group1. This guidance provides clarification on the concept of ‘significant changes in the design and intended purpose’…
Application of the requirements of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) to ‘legacy devices’ and ‘old devices’ has been clarified in new guidance1 from the Medical Device Coordination Group. MDCG 2022-8 also contains a non-exhaustive table…
Medical Device Coordination Group (MDCG) guidance 2022-91 sets out recommended templates to be used by in vitro diagnostic (IVD) manufacturers for preparing a Summary of Safety and Performance (SSP) for Class C and D devices, other than devices for performance…
A question-and-answer document on the interface between Regulation (EU) 536/2014 on clinical trials for medicinal products for human use (CTR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) has been published as Medical Device Coordination Group guidance…
In July 2022, the Medical Device Coordination Group published MDCG 2022-12 to provide guidance to Member States and other relevant parties on harmonised administrative practices and alternative technical solutions for compliance with Regulation (EU) 2017/746 on in vitro diagnostic medical…
On 30 June 2022, the European Medicines Agency (EMA) released EMA/619893/2022, Questions & Answers – Practical arrangements on the companion diagnostics consultation procedure to the European Medicines Agency by notified bodies1. Topics addressed in the document are: how and…
