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…
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…
Introduction Traditionally, artificial intelligence (AI) algorithms are trained in a centralised manner where all the data samples are collected on one device or server. This approach requires the hospitals/partners to give permission to algorithm manufacturers to access and collect patient…
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…
A new business intelligence platform has been launched to provide information on clinical investigations involving medical devices authorised in Brazil1. This business intelligence platform provides transparency into the status of the Agency’s approvals by allowing users to consult various data,…
Feedback is being solicited on draft guidance entitled Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle1,2. This draft guidance clarifies the principal concepts that sponsors and other interested parties should consider when choosing to collect and submit…
To provide consumers and healthcare professionals with important information about clinical trials that supported the approval of new medical devices, the Center for Devices and Radiological Health (CDRH) is piloting1 providing device trial participation snapshots to highlight certain information about…
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…
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…
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…
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…
Normative Instruction (IN) No. 321 of 19 September 20241, which was published in the Official Gazette No. 185 of 24 September 2024, establishes inspection procedures to harmonise, guide and verify compliance with Good Clinical Practices (GCP) in clinical investigations involving…
Introduction Clinical investigations are the driving force behind advances in healthcare, such as the discovery of new therapeutic medicines and new diagnostic technologies, as well as the development of more effective and safe medical devices. When designing a clinical investigation,…
Clinical Considerations for Studies of Devices Intended to Treat Opioid Use Disorder has been published1,2 by the Food and Drug Administration to help spur innovative options to combat the opioid overdose crisis and treat opioid use disorder (OUD). This final…
Comments are being accepted until 26 September 2024 on draft guidance for industry entitled, Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies1,2. Issuance of this draft guidance is mandated under the Food and Drug…
From 1 July 2024, Swissmedic will reduce the fees for processing applications for non-commercially funded clinical trials by 80%1 in an effort to boost Switzerland’s profile as a clinical research location. To qualify for a fee reduction, the sponsor must…
Guidance has been published1 that sets out criteria for determining when a medical device or an accessory for a medical device should be regarded as an ‘orphan device’ under Regulation (EU) 2017/745 on medical devices (MDR). It aims to guide…
The user guide1 for the Clinical Trial Notification (CTN) form has been updated (version 1.4, May 2024) to reflect recent updates to the online CTN form that came into effect on 5 April 2024. The CTN form now includes new…
In an effort to improve the management of medical device clinical trial institutions and standardise their supervision and inspection, the National Medical Products Administration (NMPA) has published Measures for the Supervision and Inspection of Medical Device Clinical Trial Institutions (Trial)1,…
Administrative requirements for the temporary importation and use of medical devices by medical institutions to meet an urgent clinical need have been issued and implemented in China through publication of Announcement No. 97 of 20241. These requirements clarify the obligations…
The Egyptian Drug Authority is holding a public consultation until 18 July 2024 on the draft regulatory guideline, Guideline for Preclinical Testing and Clinical Investigation for Medical Devices1, which is intended to provide guidance to those involved in designing pre-clinical…
MDCG 2024-5, Guidance on Content of the Investigator’s Brochure for Clinical Investigations of Medical Devices, was published by the Medical Device Coordination Group (MDCG) on 17 April 20241. This guidance document is intended to assist sponsors in developing their Investigator’s…
MDCG 2024-3 was published in March 2024 to provide guidance on the content of a Clinical Investigation Plan (CIP) for the clinical investigation of medical devices1. The Medical Device Coordination Group (MDCG) used the requirements of both Regulation (EU) 2017/745…
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…
Comments were accepted until 29 April 2024 on a draft guidance for industry entitled Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for [Food and Drug Administration] FDA-Regulated Medical Products1,2. This draft guidance sets out the…
The Therapeutic Goods Administration (TGA) has sought public feedback on two draft guidance web pages that it plans to publish1. The first web page explains how the review of Clinical Trial Notifications for first-in-human clinical trials of the highest-risk implantable…
The Recommended Path for Clinical Evaluation of Relevant Products in the ‘Medical Device Classification Catalogue’ (2024 supplement) was published on 15 March 20241. Based on the latest product research and development and application status, clinical evaluation and supervision, scientific research…
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…
Introduction The notion of health data is very broad. It encompasses past, present and future health data, as well as data which, when cross-referenced with other data, provide information on a person’s state of health1. For example, the number of…
In December 2023, the Medical Device Coordination Group (MDCG) published MDCG 2023-7, Guidance on exemptions from the requirement to perform clinical investigations pursuant to Article 61(4)–(6) MDR and on ‘sufficient levels of access’ to data needed to justify claims of equivalence1.…
The question-and-answer style guidance document that was designed to assist sponsors of clinical investigations of medical devices conducted within the scope of Regulation (EU) 2017/745 has been updated by the Medical Device Coordination Group (MDCG)1. MDCG 2021-6 Rev. 1 adds…
Final guidance for industry entitled Digital Health Technologies for Remote Data Acquisition in Clinical Investigations was issued on 21 December 20231,2. This guidance provides recommendations for ensuring that a digital health technology (DHT) is fit for purpose (i.e. that the…
Draft Resolution No. 1123 of 27 October 2022, which contained provisions pertaining to the performance of clinical trials with medical devices in Brazil, was adopted as Resolution RDC No. 837 of 13 December 20231. This Resolution came into force on the…
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…
A period of public consultation has been held on a revised draft of GN-20, Guidance on Clinical Evaluation1. The updates reflect the Health Sciences Authority’s position on the use of real-world data in medical device clinical evidence, as well as…
Introduction The introduction of Regulation (EU) 2017/745 on medical devices (MDR)1 in May 2021 has considerably raised the level of regulatory requirements for the European medical device industry. To continue to CE mark devices across Europe, there are increased expectations…
The Catalogue of Medical Devices Exempted from Clinical Evaluation (2023) has been published and is in effect1. It is worthy of note that this catalogue is the first of its kind to refer to ‘clinical evaluation’ as opposed to ‘clinical…
The fourth revision of GN-16, Guidance on Essential Principles for Safety and Performance of Medical Devices, makes a minor change to Annex 1, section 9 on clinical evaluations1. A note has been added stating that clinical investigations are generally expected…
Interested parties have until 14 November 2023 to submit comments on the following draft guidance documents for medical devices with indications for use associated with weight loss1: Medical Devices with Indications Associated with Weight Loss – Non-Clinical Recommendations2; Medical…
Interested parties had until 26 October 2023 to comment on the Food and Drug Administration’s draft guidance entitled, Clinical Considerations for Studies of Devices Intended to Treat Opioid Use Disorder (OUD)1,2. This draft guidance outlines key considerations intended to aid…
Information about changes to the operation of certain clinical investigations and performance studies in Northern Ireland has been released by the Medicines and Healthcare products Regulatory Agency (MHRA)1. Certain clinical investigations and performance studies that take place in Northern Ireland…
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 has published guidance1 on the content and structure of the summary of the clinical investigation report required under Article 77(6) of Regulation (EU) 2017/745 on medical devices. The purpose of this guidance is to ensure that the…
Two Ministerial Decrees were published in the Official Gazette (No. 136) of 13 June 2023 concerning: the administrative procedures of national relevance for the presentation of applications for clinical investigation for devices that are not CE marked or are…
Comments were accepted until 1 August 2023 on new draft guidance that provides recommendations for sponsors, investigators and other stakeholders on the implementation of decentralised clinical trials (DCTs) to advance medical product development and research1,2. Examples of decentralised elements include…
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…
What is artificial intelligence? According to the European Parliament, artificial intelligence (AI) is any tool used by a machine to ‘display human-like capabilities such as reasoning, learning, planning and creativity’1. AI was first conceived in 1943 with the publication of…
The European Medicines Agency (EMA) has launched a pilot for providing scientific advice on the intended clinical development strategy and proposals for clinical investigation for certain high-risk medical devices1. This scientific advice applies to all Class III devices and Class…
Four Decrees affecting Ethics Committees, which are fundamentally important for streamlining and improving the regulatory approval process for clinical trials in Italy, were published in the Official Gazette (No. 31) on 7 February 20231. The Decree of the Minister of…
