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…
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…
Introduction The European Union (EU) medical devices sector encompasses more than 38,000 companies, approximately 90% of which are small and medium sized enterprises (SMEs), and employs over 930,000 people across Europe1. Regulation (EU) 2017/745 on medical devices (MDR) and Regulation…
Introduction The rapid growth of artificial intelligence (AI) within healthcare has challenged Europe’s regulatory infrastructure and amplified regulatory pressures. Regulation (EU) 2017/745 on medical devices (MDR)1 and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR)2 have established rigorous…
Artificial intelligence (AI) has the potential to transform the delivery of healthcare by automating complex tasks that traditionally required substantial training and expertise. Contrary to speculations that fully automated AI will replace healthcare providers, a more likely scenario is that…
Why does PMS matter? Medical devices save and improve lives every day. However, no device is risk free. Complications, failures, or unexpected effects can occur in real patients that were not seen during pre-market development. Post-market surveillance (PMS) is the…
Introduction In 2022, the Journal of Medical Device Regulation published an article1 by this author describing the prospects for the evolution of ISO 10993-1, with particular attention to the progressive alignment with the ISO 14971 risk management system and the…
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…
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 The Unique Device Identification (UDI) system is a fundamental component of the medical device regulatory framework in Europe, which was established to strengthen traceability, improve post-market surveillance, and enhance patient safety. The UDI system uses a standardised coding system…
Introduction The passage of the update to the Federal Food, Drug, and Cosmetic Act (FFD&C Act) by the US Congress in December 20221 resulted in the addition of section 524B entitled ‘Ensuring Cybersecurity of Medical Devices’, which identifies a cyber…
Introduction Like many sectors and industries, medical technology is facing a pivotal shift. As the European Union (EU) accelerates its transition towards a circular economy, regulatory frameworks that have historically focused on waste are converging with those that address product…
Introduction The Breakthrough Devices Program is intended to expedite the development of, and prioritise the US Food and Drug Administration’s (FDA’s) review of, certain medical devices designated as ‘breakthrough devices’ that provide for more effective treatment or diagnosis of life-threatening…
Historical background Switzerland has long maintained a close regulatory relationship with the European Union (EU), despite not being a Member State. For medical devices, this relationship was supported by a Mutual Recognition Agreement (MRA), which facilitated seamless market access between…
Regulatory overview of SaMD in India The regulatory landscape for software as a medical device (SaMD) is rapidly evolving in response to the healthcare sector’s growing reliance on digital innovations such as artificial intelligence (AI), wearables, and telehealth. Globally, regulatory…
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…
Introduction On 1 August 2024, the legal landscape for medical devices containing artificial intelligence (AI) was changed beyond recognition by the entry into force of Regulation (EU) 2024/1689 (the AI Act)1. Unlike vertical regulations such as Regulation (EU) 2017/745 on…
Introduction The Medical Device Single Audit Program (MDSAP) is an initiative that allows medical device manufacturers to undergo a single regulatory audit to satisfy the requirements of multiple participating regulatory authorities. Fully operational since 2017, MDSAP has revolutionised the regulatory…
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 Once a medical device is placed on the market, post-market surveillance (PMS) becomes crucial for identifying any unforeseen issues or risks that may not have been detected during the development phase. This article provides a comparative analysis of PMS…
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…
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…
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…
Introduction The topic of regulatory advertising and promotion encompasses the laws, regulations, and guidelines that control how companies market and advertise their medical devices and/or services. It is a niche and specialised area, which requires a unique blend of regulatory…
Introduction In Canada, along with the rest of the world, the use of digital health technologies, including software-based medical devices, has risen dramatically. According to Health Canada, digital health technologies and software-based medical devices can improve access to healthcare information,…
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,…
Introduction The global medical device market has grown increasingly over the years and is projected to hit a staggering US$800 billion by the year 20301. This massive growth in the industry, which is undoubtedly due to its strategic importance in…
Introduction The medical device cybersecurity landscape continues to evolve rapidly with increasing medical device connectivity and an increased frequency and severity of cybersecurity threats to the healthcare sector1. Cybersecurity threats that target medical devices can render medical devices and hospital…
Introduction On 2 February 2024, the Food and Drug Administration (FDA) published a final rule to implement the most significant revisions in the FDA’s quality system requirements for medical devices in decades1. Specifically, the final rule – known as the…
Legal framework for SaMD in Japan Development and commercialisation of innovative products/services, including smart technologies, have recently been accelerating rapidly in the healthcare industry. One example is the growing use of artificial intelligence/machine learning technologies in medical devices that perform…
Overview The European database on medical devices (EUDAMED) is considered the digital backbone for the European Union’s (EU’s) regulatory framework for medical technologies – Regulation (EU) 2017/745 on medical devices (MDR)1 and Regulation (EU) 2017/746 on in vitro diagnostic medical…
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…
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…
Introduction While work to reach an agreed position on the final text of the European Union (EU) Artificial Intelligence (AI) Act1 continues, the European Commission has also set out a draft proposal for an AI Liability Directive (AILD)2, in conjunction…
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…
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…
Introduction Unique Device Identification (UDI) provides important regulatory and supply chain functions for medical devices. It allows for tracking of devices throughout the global supply chain to the patient, it offers global visibility to device adverse event reporting, and it…
Introduction The global medical device market in 2022 was worth US$512.29 billion and is projected to grow to US$799.67 billion by 2030 at a compounded annual growth rate of 5.9%1. Much of the rapid growth of the medical device sector…
Introduction The regulatory gap between the actions of medical device companies and the expectations of the US Food and Drug Administration (FDA) is seen through violations captured in issued warning letters. Many violations of Title 21 of the Code of…
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…
Regulatory background The ‘green channel’ is an official expression used by China’s National Medical Products Administration (NMPA) for its three fast-track processes that have been established to encourage innovation and deal with unmet medical needs: innovation approval, priority review, and…
Introduction/background The increasing complexity of new medical devices fuels the discussion about the need for a ‘regulatory science’ for medical devices, to be developed in parallel to the implementation of Regulation (EU) 2017/745 on medical devices (MDR). The combination of…
Introduction Third generation Generative Pre-trained Transformer (GPT-3) is an autoregressive language model released in 2020 that uses deep learning to produce human-like text. Given a small amount of input text it can generate large volumes of relevant and sophisticated machine-generated…
Introduction On 25 May 2017, Regulation (EU) 2017/7451 on medical devices (MDR) came into force and repealed Directives 93/42/EEC and 90/385/EEC. After a transition period, the MDR went into force on 25 May 2021, and medical devices must now meet the requirements…
Introduction Three dimensional (3D) printing offers endless possibilities for cost effectively accelerating the design, production, and delivery of patient-matched medical devices for enhancing and saving lives. Also known as additive manufacturing, 3D printing has been around for decades. However, recent…
Introduction Sustainability is not a new concept. For some time, medical technology companies have been working on several sustainability related issues (e.g. packaging waste, affordability), yet new systemic perspectives and challenges are emerging. Medical technology companies, like all companies worldwide,…
Introduction The entire Brazilian regulatory framework for medical devices has undergone a fundamental review to ensure a high level of health and safety, bringing more robustness, transparency, predictability and sustainability to manufacturers, importers, exporters, distributors and the market. The new…
Introduction When the Digital Healthcare Act (Digitales Versorgungsgesetz, DVG) entered into force in December 2019, a dedicated pathway enabling reimbursement of digital health offerings was introduced to the German healthcare system1. This enabled patients in the Statutory Health Insurance (SHI) system…
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…
