Introduction At a high level, a literature review can be divided into three steps: literature search, article screening, and data extraction. Each step is of critical importance to the review process and requires specialised skills and clinical knowledge to accomplish…
Numerous guidance documents have been published recently by the Medicines and Healthcare products Regulatory Agency (MHRA) on various topics relating to medical device clinical investigations: Medical devices that need a clinical investigation1 – How to determine if it will…
A period of public consultation1 has been held on a draft Announcement of the Ministry of Public Health Regarding the Criteria, Methods, and Conditions for the Use of Medical Devices in Clinical Research Studies, B.E. designed to revise and modernise…
Introduction Provision of sufficient clinical evidence is fundamental to demonstrating medical device safety, performance and acceptability of benefit-risk under Regulation (EU) 2017/745 on medical devices (MDR)1. While pre‑market clinical data remain essential to support initial CE marking, they may not…
ISO 14155:2026, Clinical investigation of medical devices for human subjects – Good clinical practice (Edition 4) was published in March 20261. This standard specifies Good Clinical Practice (GCP) for the design, conduct, recording and reporting of clinical investigations carried out…
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…
The Finnish Medicines Agency (Fimea) has published a clinical investigation plan template1 designed to ensure that clinical studies meet the basic requirements of both Regulation (EU) 2017/745 on medical devices and Finland’s national legislation. The new template provides a clear…
On 20 March 2026, the European Commission adopted two Delegated Regulations1 that will expand the list of well-established technologies referred to in Regulation (EU) 2017/745 on medical devices (MDR), with a view to exempting them from some legal requirements and…
A Notice regarding matters relating to the pre-review of clinical trial protocols for innovative medical devices was issued by the Center for Medical Device Evaluation on 13 March 20261. This initiative allows applicants developing innovative devices to request a pre-review…
Guidance on clinical evidence requirements for medical devices (April 2026) provides updated advice to manufacturers of Class II, III and IV medical devices and regulatory representatives on the clinical evidence requirements for medical devices1. Guidance is provided on when clinical…
Comments were accepted until 16 January 2026 on a draft guidance entitled, Menstrual Products – Performance Testing and Labeling Recommendations1,2. This draft guidance document provides recommendations for performance testing, labelling, and information for inclusion in pre-market notification (510(k)) submissions, when…
Final guidance for investigators, industry and Institutional Review Boards (IRBs) entitled, Investigator Responsibilities – Safety Reporting for Investigational Drugs and Devices, was issued by the Food and Drug Administration in December 20251,2. The purpose of this guidance is to help…
On 6 January 2026, Clinical Decision Support Software – Guidance for Industry and Food and Drug Administration Staff was published to supersede the 2022 guidance of the same name1. This updated guidance clarifies the scope of the Food and Drug…
Interested parties have until 24 March 2026 to submit comments on the draft guidance entitled, Cuffless Non-invasive Blood Pressure Measuring Devices – Clinical Performance Testing and Evaluation1,2. This draft guidance provides recommendations for clinical performance testing and evaluation to support…
Guidance from the Medicines and Healthcare products Regulatory Agency (MHRA) on how to notify the MHRA of an intention to carry out a clinical investigation for medical devices1 has been updated numerous times over the past three months. In January…
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…
Law No. 71/2025, which was published in the Official Gazette on 22 December 2025, establishes a national regime applicable to clinical research on medical devices and performance studies of in vitro diagnostic medical devices (IVDs)1, within the scope of the…
The Finnish Medicines Agency (Fimea) has published a new infographic1 to support researchers in the design of clinical trials in accordance with Article 82 of Regulation (EU) 2017/745 on medical devices. The infographic describes the special features of research under…
A pilot coordinated assessment of clinical investigations and performance studies has been launched1 across multiple Member States as per Article 78 of Regulation (EU) 2017/745 and Article 74 of Regulation (EU) 2017/746. This pilot will allow sponsors to submit a…
Introduction Since the publication of Regulation (EU) 2017/745 on medical devices (MDR)1, there has been constant discussion on the topic of equivalence. The discussion often pauses with the statement that a clinical evaluation based on an equivalence assessment is no…
Final guidance entitled Animal Studies for Dental Bone Grafting Material Devices--Premarket Notification (510(k)) Submissions has been published by the Food and Drug Administration1,2. This guidance document provides recommendations for animal study design and animal study information to be included in…
The Medicines and Healthcare products Regulatory Agency’s guidance page on clinical investigations for medical devices1 has undergone numerous updates over the past couple of months. In August 2025, the wording in the ‘Payment for a clinical investigation’ section was revised…
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…
Scope and relevance of the Data Act for the medical device industry With the European Union (EU) Data Act (Regulation (EU) 2023/2854)1, the European legislator has stripped manufacturers of their de facto ownership of device data and handed enforceable access…
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…
The Ministry of Health is preparing a Digital Health Bill to regulate the use of big data in research and clinical trials1. The future law will ensure that all citizens, both in the public and private sectors, have access to…
The Spanish Agency for Medicines and Medical Devices (AEMPS) has published a memorandum1 that establishes the basis for collaboration and communication between the AEMPS – as the Competent Authority for medical devices and in vitro diagnostics (IVDs) – and the…
The second revision of GL-08, Regulatory Guidelines for Laboratory Developed Tests (LDTs), was released in September 20251. This document provides guidance and clarity to clinical laboratories on the regulatory requirements applicable to LDTs under the Health Products Act 2007 and…
A public consultation has been held on the document Draft Financial Agreement – Clinical Research on Medical Devices1, an initiative launched by the Working Group for the Promotion of Clinical Research on Medical Devices in Portugal, which includes representatives from…
Commission Implementing Regulation (EU) 2025/2086 was published on 20 October 20251 to set out the procedural rules for the interaction during, exchange of information on, and participation in, the preparation and update of joint clinical assessments of medical devices and…
Information provided by the Therapeutic Goods Administration (TGA) on how clinical decision support system (CDSS) software is regulated, including when such products are and are not exempt from inclusion in the Australian Register of Therapeutic Goods (ARTG), was updated in…
The Federal Institute for Drugs and Medical Devices (BfArM) released a new version of the German Medical Devices Information and Database System (DMIDS) module ‘Clinical Trials and Performance Studies’ on 1 July 20251. This new version includes updated technical functionality…
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…
Interested parties have been provided with an opportunity to submit comments on a proposed Commission Implementing Regulation that sets out procedural rules for the interaction during, exchange of information on, and participation in, the preparation and update of joint clinical…
An updated catalogue of medical devices exempt from clinical evaluation was published on 13 May 20251. In total, 1047 medical devices have been exempted from clinical evaluation. This latest update adds seven Class III medical devices and 21 Class II medical devices…
Introduction The National Drug Authority (NDA) has a mandate to ensure the availability, at all times, of essential, efficacious and cost-effective drugs to the entire population of Uganda, as a means of providing satisfactory healthcare and safeguarding the appropriate use…
Introduction Regulatory frameworks for medical devices have historically balanced innovation with patient safety. Yet, as medical technologies become increasingly modular, software enabled and patient specific, traditional regulatory models – rooted in predicate comparison or exhaustive clinical trials – struggle to…
In the absence of a fully functioning European Database on Medical Devices (EUDAMED), in Spain, a sponsor must submit1 a clinical research report and its summary within one year of completion of the research, or within three months in the…
A pilot coordinated assessment of clinical investigations and performance studies has been launched1 across multiple Member States as per Article 78 of Regulation (EU) 2017/745 on medical devices (MDR) and Article 74 of Regulation (EU) 2017/746 on in vitro diagnostics…
On 5 March 2025, Regulation (EU) 2025/327 on the European Health Data Space (EHDS) was officially published in the Official Journal of the European Union1 and entered into force later that month, marking the beginning of the transition period. The…
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…
In order to standardise and improve the quality of inspections of medical device clinical trials, the National Medical Products Administration has revised its Key Points and Judgment Principles for Inspection of Medical Device Clinical Trial Projects1. The drug regulatory authorities…
In February 2025, the Therapeutic Goods Administration (TGA) published the outcome1 from a public consultation paper entitled, Proposed clarification of how Clinical Decision Support System (CDSS) software is regulated. This consultation sought feedback on the appropriateness of the current exemption…
A draft guidance for industry entitled Study of Sex Differences in the Clinical Evaluation of Medical Products has been released for public comment1,2. Clinical trials and non-interventional studies of medical products should be designed to enrol sufficient numbers of females…
Comments are being accepted until 7 April 2025 on a draft guidance entitled, Evaluation of Sex-Specific and Gender-Specific Data in Medical Device Clinical Studies, which provides guidance on the study and evaluation of sex- and/or gender-specific data in clinical investigations…
Guidance has been drafted on protocol deviations for clinical investigations of drugs, biological products, and medical devices1,2. Protocols document the study design, objectives, population, planned procedures, investigational product management, method(s) of data capture, monitoring and oversight plans, and statistical analysis…
Introduction The European Health Data Space Act (EHDS Act) represents a pivotal legislative initiative aimed at reshaping the way health data are accessed, shared, and utilised across the European Economic Area (EEA). Although not yet published in the Official Journal…
Introduction Post‑Market Clinical Follow‑up (PMCF) is a continuous process conducted by manufacturers to proactively collect and evaluate clinical data for the medical devices that they have placed on the market. The PMCF process updates the clinical evaluation. With the implementation…
The ‘COMBINE’ programme strategy was published1 in December 2024 to clarify the vision, the structure and governance, overall plan of activities, the ways of working and approach to evaluation of the activities in the second phase of COMBINE. Member States’…
On 12 January 2025, Regulation (EU) 2021/2282 on health technology assessment (HTA) became applicable, creating a European Union (EU) framework for the assessment of health technologies (e.g. medical devices) by fostering collaboration and coordination between Member States1,2. The Regulation should help…
