Introduction A medical device ‘shall be safe and effective, […] taking into account the generally acknowledged state of the art’1: in other words, safety and efficacy are essential to a medical device. Safety, according to Regulation (EU) 2017/745 on medical…
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…
Introduction Connectivity is increasingly a standard feature of medical devices. The significant benefit that connectivity brings also comes with challenges, notably around cybersecurity. The transition to fully networked and connected equipment allows innovative new ways of diagnosing, monitoring and treating…
Introduction Humans have historically endeavoured to innovate and design processes to make life better. The application of artificial intelligence (AI) is changing our thinking, making us reconsider our technology choices, and redesign and change our processes. AI is the science…
Introduction In the last 10 to 15 years, there has been a significant evolution in both the substance and interpretation of European regulatory requirements for clinical evaluation. The core objective has been to ensure that all medical devices have clinical…
Introduction The introduction of the European Medical Device Regulation (2017/745, MDR)1 back in May 2021 has considerably raised the level of regulatory requirements across the medical device industry. To continue to CE mark their devices across Europe, there are increased…
Introduction We are all unique, it is the one thing we have in common. It is precisely this uniqueness that is the foundation for precision medicine, basing treatment decisions on who we are rather than the disease we have. In…
Introduction Post-market surveillance (PMS) is a topic of increasing importance in the regulation of medical devices, as recently demonstrated by the significant increase in PMS requirements in the European Union (EU) under Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746…
The idea of a common Eurasian medical device market The Eurasian Economic Union (EAEU) comprises Russia, Kazakhstan, Belarus, Armenia and Kyrgyzstan and has a combined population of more than 184 million. In its first five years, the gross domestic product…
The US medical device ecosystem The medical device ecosystem in the USA consists of a spectrum of stakeholders including device manufacturers, regulators, patients, health systems, clinicians and payors. The US Food and Drug Administration (FDA) oversees the regulation of the…
Introduction The new Regulation (EU) 2017/745 on medical devices (MDR)1 introduces a paradigm shift for Post-Market Surveillance (PMS)2–4. According to ISO/TIR 20416:20205, six major functions of a medical device’s lifecycle interact with PMS processes, namely design development, clinical evaluation, activities…
Introduction In Europe, medical devices have been regulated centrally since the 1990s when Directive 90/385/EEC (the Active Implantable Medical Device Directive, AIMD Directive1) and Directive 93/42/EEC (the Medical Device Directive, MDD2) were published. However, even though these Directives underwent a…
Introduction In several markets, such as China, Australia, Brazil and especially the European Union (EU), the requirements for demonstration of safety and efficacy/performance through clinical data have increased in recent years. Moreover, the International Medical Device Regulators Forum (IMDRF) continues…
Introduction Software has forcefully entered as a protagonist in the new Regulation (EU) 2017/745 (MDR)1 on medical devices. The word ‘software’ in the MDR occurs 48 times while the number of occurrences in the old Directive 93/42/EEC (as amended) was…
Introduction It was quite a long time ago – February 2013 to be precise – that I wrote a Guest Editorial in this Journal entitled Is the European Commission meeting the needs of manufacturers, healthcare professionals and patients with the…
Transition to the IVDR: an overview of the current situation The date of application (DoA) of the European Regulation on in vitro diagnostic medical devices (IVDs) (Regulation (EU) 2017/746, the IVDR) is set for 26 May 2022, paving the way…
Chinese medical device market The Chinese medical device market is the fourth largest in the world, with a revenue of 800 billion RMB in 20201 and an annual growth rate of around 20%. Although the Chinese government strives for ‘Made in…
Introduction In Europe, manufacturers are transitioning away from the long-established Medical Device Directive (MDD)/Active Implantable Medical Device Directive (AIMD Directive)/In Vitro Diagnostic Directive (IVD Directive) to the new but not yet fully supported Medical Device Regulation (MDR)1/IVD Regulation (IVDR)2. In…
Introduction The successful functioning of healthcare systems around the world is largely dependent on the ability to provide quality, safe, cost efficient, and effective medical services to patients. The ever-increasing pressures to reduce ‘healthcare costs, reduce estimated time to repair…of…
Introduction The implementation of the European Union’s Regulation (EU) 2017/746 on in vitro diagnostic devices (IVDR)1 on 26 May 2022 – which replaces Directive 98/79/EC (the IVD Directive) – has remained in the shadows, as the more urgent deadline of…
Introduction Ethylene oxide (EtO) gas sterilisation is often regarded as the last choice for the sterilisation of medical devices because the procedure usually leaves a miniscule amount of toxic EtO residue. However, it is still a highly effective sterilant and…
Introduction Regulation (EU) 2017/745 on medical devices (the MDR)1 will apply from 26 May 2021. On that date, the MDR will repeal Directive 90/385/EEC on active implantable medical devices and Directive 93/42/EEC on medical devices. The scope of, and emphasis…
Introduction Usability is defined by IEC 62366-1:20151 as the ‘characteristic of the user interface that facilitates use and thereby establishes effectiveness, efficiency and user satisfaction in the intended use environment’. It should be noted that all aspects of usability, including…
Introduction The UK enters a new phase from 1 January 2021, when its Brexit transition period will have ended and UK laws will be independent of those in the European Union (EU), albeit that many will be very similar. Manufacturers,…
Introduction According to Regulation (EU) 2017/745 on medical devices (the MDR)1, a medical device is defined as ‘any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for…
Introduction Over the last 40 years, the amount of software used both in, and around, medical devices has increased dramatically, and has become an increasingly prevalent and crucial component of highly sophisticated medical devices1. Software as a medical device (SaMD)…
Introduction Ophthalmic device use has seen an increase recently due to emerging technology in the areas of retinal and fundus imaging. There are different types of devices that are used to diagnose or treat eye-related disorders and most of them…
Quality in 510(k) Review Program Pilot The Quality in 510(k) Review Program Pilot is an alternate method for submitting a pre-market notification submission (510(k)) to the Food and Drug Administration (FDA) for certain device types. The method uses the FDA’s…
Introduction Artificial intelligence (AI) is making its way into our daily lives: through image search functions, digital voice assistance, and even in our personally recommended list of items to watch on popular streaming services, often without us being aware of…
Introduction According to Title 21 of the Code of Federal Regulations (21 CFR) §801.5, reprocessing instructions are considered part of a device’s instructions for use1. This regulation supports the language of the law in section 502(f) of the Federal Food,…
Introduction The manufacture of medical devices is subject to strict regulatory requirements. These requirements include complying with quality management standards, assessing and mitigating risks that are inherent in production processes, and reporting adverse events involving a manufacturer’s product to regulatory…
Introduction The approval of Regulation (EU) 2017/745 on medical devices1 represents an extraordinary opportunity for Europe. The Regulation officially introduces a new category of products with a medical purpose: medical devices composed of substances or a combination of substances. These…
Introduction The European Regulation on in vitro diagnostic medical devices (IVDR, Regulation (EU) 2017/746) was published on 25 May 2017 with a five-year transition period1. This article reviews the original intention of the Regulation to bring more transparency and traceability…
Introduction The Food and Drug Administration (FDA) has the authority to regulate medical device labelling and advertising of restricted medical devices1. Medical device companies can undertake promotional activities using labelling to advertise a device after the appropriate FDA clearance or…
Short glossary Article 117 of Regulation (EU) 2017/7451 on medical devices (the MDR) describes the requirements for the device part of drug/device combinations regulated as medicines. Rule 13 of Directive 93/42/EEC (the MDD) specifies the requirements for medical devices containing…
Introduction The new European Regulation (EU) 2017/745 on medical devices (MDR)1 provides the following definition for clinical evidence: ‘clinical data and clinical evaluation results pertaining to a device of a sufficient amount and quality to allow a qualified assessment of…
Introduction Readers who are well informed in matters concerning Economic Operators (EOs) will be aware that essential parts of the general ‘Goods Package’ were being amended and that these amendments could potentially affect the medical device industry. The Goods Package…
Introduction Both Regulation (EU) 2017/745 on medical devices (MDR)1 and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR)2 include an identical Article 7 entitled ‘Claims’, which includes obligations (both positive and negative) in relation to labelling, instructions for…
Introduction With a huge population, growing economy, and healthcare aimed at covering 1.4 billion people, China has become the second largest medical device market in the world, averaging a 20% growth rate annually. In 2018, device sales in China reached…
Introduction Nitinol is an alloy of nickel and titanium with major applications in the medical device industry due to its unique pseudoelasticity and shape memory behaviour. Nitinol has been used extensively in cardiovascular stents, heart valves, guidewires, etc, as well…
Introduction For a long time in the European Union (EU), it has been common for medical devices to be manufactured by one company but sold under the name of another company. The first company would be responsible for the design,…
Introduction Clinical research in India has experienced extreme turbulence over the last 10 years. The major contributor to this turbulence has been legal cases that have prompted immediate, reactive measures to be implemented by the regulators. While these reactive measures…
Introduction The new Regulations for medical devices1 and in vitro diagnostic medical devices (IVDs)2 are approaching their dates of application. Among the new obligations that industry must promptly comply with are those concerning the Person Responsible for Regulatory Compliance (PRRC).…
Introduction Manufacturers of medical devices placed on the market with the CE mark under the European Directives are fully acquainted with the safety and performance their products must fulfil. These requirements, defined in the form of fundamental Essential Requirements in…
Introduction The final draft (FDIS) of the third edition of ISO 14155 is, at the time of writing, being prepared for circulation and ballot as ISO/FDIS 14155:2019. At this stage, only editorial changes are permitted, so the FDIS is likely…
Introduction The pre-market notification process, or 510(k) process as it is commonly known, allows companies to fast-track clearance of a device by claiming it is ‘substantially equivalent’ to a device that has already been approved and marketed in the USA…
Introduction With the end of Regulation (EU) 2017/745’s transition period fast approaching – 26 May 2020 – pressure is mounting for Class I manufacturers to confirm compliance with the new Medical Device Regulation (MDR), otherwise they will lack the right certifications to…
Background Following recent safety issues (e.g. with Poly Implant Prothèse breast implants), the European Commission has urged Member States to tighten controls, increase surveillance, and thereby restore full confidence in the European CE marking regulatory system. The key focus areas…
Introduction The Association of South East Asian Nations (ASEAN) is composed of 10 member states: Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, the Philippines, Singapore, Thailand and Vietnam. The healthcare sector is a high priority focus area under the ASEAN Economic…
Introduction A new regulatory system for medical devices is being implemented in the European Union. The old Directives on medical devices are being replaced by a single Regulation on medical devices. Directives 93/42/EEC on medical devices (MDD)1 and 90/385/EEC on…
