Technical Reference document TR-010, Combination Products, was published on 1 April 2026 and became effective immediately1. This document aims to describe different categories of combination products and their examples. It also provides a reference regarding whether combination products meet the…
In April 2026, the fifth 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…
At the 29th meeting of the Global Harmonization Working Party (GHWP) in Bangkok, Thailand on 4 December 2025, the following Working Group (WG) guidance documents were endorsed1 according to the simple majority rule: WG1-WG2-WG3, Guidance on Determining of Lead Authority…
Companies will have until 30 May 2026 to cancel notifications for sodium chloride-based products intended for nasal irrigation that are classified as medicines and to register them as Class IV medical devices1. This regulatory change will apply to both powdered…
Introduction This article provides a comprehensive overview of recent regulatory developments in South Africa pertaining to medical devices and in vitro diagnostics (IVDs), as announced by the South African Health Products Regulatory Authority (SAHPRA). One key update involves the phased…
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…
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…
In June 2025, the third edition of the medical device guidance document MDA/GD/0063, Harmonised Borderline Products in ASEAN [Association of South East Asian Nations] was published1. This guidance document provides a list of borderline products and specifies whether they are…
In April 2025, the Finnish Medicines Agency (Fimea) launched a new advisory service for designers of combination studies1. This service offers informal advice to study developers, focusing specifically on combination studies planned in Finland and the related regulatory requirements. A…
In February 2025, the European Medicines Agency (EMA), in collaboration with the European Commission, formally established a standard procedure for manufacturers of certain high-risk medical devices to request scientific advice on their intended clinical development strategy and proposals for clinical…
Interested parties – including manufacturers, importers and distributors of all classes of medical devices included in a co-packaged drug product – have until 18 May 2025 to submit comments on a draft guidance that explains the regulatory requirements for co-packaged…
In order to adapt to the new regulations for in vitro diagnostic medical devices (IVDs), the notifications of products previously regulated under the technical name ‘solution for cleaning equipment’ are being cancelled1. ‘Solution for cleaning equipment’ means laboratory products used…
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…
Introduction In May 2020, an article in this Journal1 outlined the regulatory pathways and discussed the potential challenges for combination products of the incoming Regulation (EU) 2017/745 on medical devices (MDR). The purpose of this current article is to provide…
The guidance for industry and Food and Drug Administration staff concerning Application User Fees for Combination Products has been updated1. This revised document provides guidance on application user fees for combination products as defined under Title 21 of the Code…
On 13 September 2024, Health Canada updated its list of combination product classification decisions1, which may be used as a guide for determining the status of combination products. The current list is as follows: Combination products that have been…
The Association for the Advancement of Medical Instrumentation (AAMI) Technical Information Report (TIR) 48: 2024, Quality Management Systems (QMS) Recommendations on Application of the U.S. FDA’s cGMP Final Rule on Combination Products1, is designed to assist manufacturers with meeting the…
Guidance has been published1 to summarise the procedure for Notified Bodies to follow to obtain a scientific opinion from the Italian Medicines Agency (AIFA) on ancillary medicinal substances used in a Class III medical device. The guidance also provides recommendations…
A new revision of the question-and-answer style guidance document that clarifies the regulatory requirements for medical devices used in combination with medicines has been published by the European Medicines Agency1. This latest revision, revision 4, is based on the experience…
A period of public consultation1 is being held until 6 August 2024 to determine whether legislating some products, where possible to declare their regulatory category formally (e.g. medical device, not a medical device, or other therapeutic good), will provide additional…
On 10 April 2024, the guidance concerning notifying the Medicines and Healthcare products Regulatory Agency (MHRA) about a clinical investigation for a medical device was updated1 to include a new section on the combined review of a Clinical Trial of…
The following five guidance documents have been updated recently by the Therapeutic Goods Administration (TGA): TGA quality management system audits and certification – Guidance for manufacturers of medical devices (version 2.0, December 2023)1 This guidance provides information for medical…
In September 2023, the third 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…
A second revision of the Medical Devices Product Classification Guide (GL-06)1 was released in October 2023. This guide has been produced by the Medical Devices Branch to assist stakeholders in determining whether a product is classified as a medical device. For…
Industry and Food and Drug Administration staff have been provided with a guidance document that answers questions concerning the application of human factors engineering (HFE) principles to the development of combination products1 as defined under Title 21 of the Code…
It became a legal requirement on 22 June 2023 that the following actors established in Denmark must be registered with the Danish Medicines Agency and pay the required fee in order to be able to market products without a medical…
Since 22 June 2023, Regulation (EU) 2017/745 (MDR) now also applies to those groups of products without an intended medical purpose, listed in Annex XVI to the MDR, covered by the Common Specifications set out in Commission Implementing Regulation (EU)…
Since 22 June 2023, the European rules for products without an intended medical purpose also apply in Norway1. Many products resemble medical equipment in function and risk profile but, according to the manufacturer, only have an aesthetic or other non-medical…
The Medicines and Healthcare products Regulatory Agency (MHRA) guidance on borderline products for determining whether or not a product is a medical device has been updated to add a new Annex A on MHRA borderline determinations1. When the MHRA has established…
On 20 January 2023, the Estonian Health Board decided that if a product (e.g. a disinfectant) meets the requirements of both the Medical Device Regulation and the Biocides Regulation, dual labelling of the product is acceptable1. Previously, these products had…
In December 2022, the second 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…
The European Medicines Agency (EMA) will launch a pilot in February 2023 allowing expert panels to provide scientific advice to manufacturers of high-risk medical devices1. As per Article 61(2) of Regulation (EU) 2017/745 on medical devices, the expert panels may…
The fifth edition of the Guideline for Drug-Medical Device and Medical Device-Drug Combination Products – Endorsement Letter Application – Adverse Drug Reaction and Incident Reporting took effect on 3 January 20231. This new edition updates the name of the guideline,…
As required by the 21st Century Cures Act, the Food and Drug Administration (FDA) has published a list of alternative or streamlined mechanisms1 for complying with the current Good Manufacturing Practice (cGMP) requirements for combination products. In response to comments…
The Therapeutic Goods Administration (TGA) is seeking feedback by 20 November 2022 on its draft guidance entitled Boundary and combination products – medicines, medical devices, and biologicals1. The purpose of this draft guidance is to assist sponsors and manufacturers in…
Guidance MDA/GD/0063 (August 2022, first edition) provides a list of borderline products and clarifies whether they are medical devices or non-medical devices based on their intended purpose as claimed by the manufacturer1. Malaysia’s list is harmonised with the list drawn…
In September 2022, the first 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…
Final guidance has been published on the Principles of Premarket Pathways for Combination Products1,2 to clarify the Food and Drug Administration’s (FDA’s) current thinking on the subject. This guidance includes general, high-level information regarding what combination products are, coordination within…
On 26 April 2022, MDCG 2022-5, Guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devices, was published1. This guidance provides explanations and examples to clarify the demarcation between the legal frameworks for medical…
A Commission Implementing Decision has been drafted1 on the group of products whose principal intended action, depending on proanthocyanidins (PAC) present in cranberry (Vaccinium Macrocarpon), is to prevent or treat cystitis. Following a request from the French authorities, the Commission…
A new guideline has been published by the Malaysian authorities to explain the registration requirements for drug-medical device and medical device-drug combination products1. The guideline includes information relating to dossier requirements, procedures for submission of combination product registration applications, timeframes…
The Food and Drug Administration (FDA) has delayed the effective date of a final rule entitled Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding `Intended Uses’ until…
A Circular has been drafted on the categorisation of borderline health products under the jurisdiction of the Food and Drug Administration1, which includes medical devices, drugs, cosmetics, household/urban hazardous substances and food. The Circular sets out the procedure for applying…
On 1 January 2022, the European Medicines Agency’s (EMA’s) Guideline on quality documentation for medicinal products when used with a medical device will become effective1. This guideline outlines the information that should be presented in the quality part of a…
A final rule has been issued1 to amend the medical product ‘intended use’ regulations for medical devices and for drugs. This final rule amends the regulations that describe the types of evidence relevant to determining whether a product is intended…
At the end of July 2021, the National Medical Products Administration revised the rules for the registration of drug-device combination products (Announcement No. 52 of 20211) to address some of the issues that have made it difficult for combination products…
In October 2021, the Ethiopian Food and Drug Authority (EFDA) published new Guidelines for Borderline Medical Devices1. As many manufacturers have difficulty in interpreting whether their product would be considered a medical device within the Food and Medicine Administration Proclamation…
A question-and-answer (Q&A) document on the implementation of Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices has been comprehensively updated by the European Medicines Agency (EMA)1. This second revision, dated 23 June…
Final guidance has been published for industry and Food and Drug Administration (FDA) staff on Requesting FDA Feedback on Combination Products1,2. The guidance outlines ways in which combination product sponsors can obtain feedback from the Agency on scientific and regulatory…
The European Association for Medical Devices of Notified Bodies (Team-NB) has released a Position Paper1 on the interpretation of device-related changes to an integral drug/device combination product in relation to a Notified Body Opinion, as required under Article 117 of…
