Introduction The Breakthrough Devices Program (BDP) and the Safer Technologies Program (STeP) are Food and Drug Administration (FDA) programmes intended to incentivise and speed the development of innovative medical devices that meet certain criteria.The BDPincentivises development of medical devices that…
Introduction It is now accepted that there is a broad concept of digital health, which includes in its scope categories such as mobile health (mHealth), wearable devices, tele-health and tele-medicine, artificial intelligence (AI) algorithms and robotics. Stakeholders are using digital…
Introduction Time is running out to transition fully to the new European Union (EU) Medical Devices Regulation (MDR)1 and In Vitro Diagnostics Regulation (IVDR)2. With less than two years to comply for the MDR and four years for the IVDR,…
Introduction: The TGA – a small agency with a big footprint Australia’s Therapeutic Goods Administration (TGA) is an internationally respected agency that operates comprehensive regulatory frameworks for medicines, biologicals and medical devices, including in vitro diagnostics (IVDs).The TGA was a…
Introduction The Product Liability Directive 85/374/EEC1 sets out the liability for defective products in the European Union (EU). It is reviewed every five years, with the Commission producing a report that takes into consideration the efficacy of the legislation, its…
Introduction The Medical Device Regulation (Regulation (EU) 2017/745), or MDR, entered into force on 26 May 2017 with a transitional period of three years. Therefore, manufacturers have less than two years left to fulfil and implement the enhanced requirements. A major component is…
Introduction Medical devices are modified for numerous reasons as part of the innovation process as well as to address changes in technology. For medical devices cleared via the US Food and Drug Administration’s (FDA’s) pre-market notification (510(k)) process, review of…
Introduction Notified Bodies (NBs) are the entities responsible for assessing and granting certificates for the majority of medical devices and in vitro diagnostics (IVDs) placed and distributed in the European market and beyond. The new Medical Device Regulation (EU) 2017/745…
Introduction Parallel Review is designed to bring innovative medical devices to the American public in an expeditious manner. To accomplish this, the US Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health (CDRH) and the Centers for Medicare…
Introduction In recent years, the number of combination products entering the global market has grown significantly due to advances in medical technology as well as an increase in user demand. While these products hold great promise for the future of…
Introduction The Food and Drug Administration (FDA) Commissioner, Dr Scott Gottlieb, authored a blog post on 9 May 2018 discussing the Spring 2018 Unified Agenda of Federal Regulatory and Deregulatory Actions1, which provides federal agencies with the opportunity to update the American…
Introduction On 5 May 2017, the new Regulation 2017/745 on medical devices (MDR) was enacted, with a full implementation date across the 28 European Union (EU) Member States set for 26 May 20201. On this day, the Regulation will replace…
Introduction The question of Authorised Representative (AR) liability has been a recurrent topic of conversation for manufacturers, lawyers and regulators.The argument is that as ARs are recognised as de facto manufacturers in situations where there is no manufacturer within the…
Introduction The world of laboratory testing is becoming more complicated and more complex, with genetic testing at the forefront. At the same time, global economies have changed and health insurance is now radically different with the passing of the Affordable…
Introduction The original guidance from the US Food and Drug Administration (FDA) on the biological evaluation of medical devices was The Blue Book Memorandum #G95-1, Use of International Standard ISO-10993, ‘Biological Evaluation of Medical Devices Part 1: Evaluation and Testing’,…
Introduction Medical devices distributed in Japan are subject to the Act on Securing Quality, Efficacy and Safety of Pharmaceuticals, Medical Devices, Regenerative and Cellular Therapy Products, Gene Therapy Products, and Cosmetics (PMD Act), which has been enforced since November 2014…
The reprocessing of single-use medical devices (SUDs) takes place worldwide, including, to varying levels, within European hospitals. Manufacturers, hospitals and commercial companies have historically been subject to different regulatory requirements but this will all change with the adoption of the…
The risks in medical device development stem largely from uncertainty. This includes uncertainty about a device’s safety and efficacy, about the patients for whom it may be more effective or contraindicated, and about how it compares with existing therapies –…
Di (2-ethylhexyl) phthalate (DEHP) is a plasticiser largely used in medical devices for its excellent flexibility properties. In particular, DEHP is incorporated into tubing, bags and catheters, which are often installed in larger electronic medical devices (e.g. medical imaging devices).…
In June 2016, the revised European guideline MEDDEV 2.7/1 revision 4 was published1. It became effective immediately, leaving no time for manufacturers or Notified Bodies to prepare for the changes. The lack of a transition period also left no time…
Introduction India is one of the largest medical device markets globally and therefore needs a robust system for the regulation of medical devices. At present only a few medical devices in India are regulated as drugs under the Drugs and…
Introduction On 5 May 2017, Regulation (EU) 2017/745 on medical devices (MDR)1 and Regulation (EU) 2017/746 on in vitro diagnostics (IVDR)2 were finally published in the Official Journal of the European Union. The twoRegulations will enter into force in all Member…
Introduction In late 2012, the European Commission published its proposals for two new Regulations, one for medical devices and one for in vitro diagnostics (IVDs), to replace the current Directives which have been in place for over 25 years (Directive…
Introduction In May 2017, the Medical Devices Regulation and the In Vitro Diagnostics (IVD) Regulation ((EU) 2017/7451 and (EU) 2017/7462, respectively) came into force 20 days after their publication in the Official Journal. This marked the end of a very…
Introduction The 21st Century Cures Act was signed into law on 16 December 2016. Putting aside whether enough funds will be dedicated to enacting Food and Drug Administration (FDA) policies, is this the legislation that will bring the FDA back…
Introduction After years of intensive and lengthy consultations, the new Medical Device Regulation (MDR)1 and In Vitro Diagnostics Regulation (IVDR)2{European Union (EU), 2017 #31} were finally adopted by the European Parliament in May 2017. With a transition period of three years…
What is MDSAP? The regulatory environment of the medical device industry is constantly evolving which means it is not always clear which changes must be responded to. Among these changes is the Medical Device Single Audit Program (MDSAP), which impacts…
Introduction The Brazilian post-market surveillance (PMS) system, known as Technovigilance, is a monitoring system for adverse events and technical complaints of medical devices and in vitro diagnostic (IVD) products in the post-market phase. Its purpose is to ensure the adoption…
Introduction It is well recognised that the new Medical Device Regulation (EU) 2017/745 (MDR)1will have a significant impact on device manufacturers, Notified Bodies (NBs) and device Competent Authorities (CAs). However, it will also affect how the increasing number of drug/device…
1. Clinical evaluation and clinical investigations[medical devices] / Performance evaluation and performance studies [IVDs] 2. Scope and classification 3. Notified Bodies and conformity assessment 4. Post-market surveillance and vigilance for both medical devices and IVDs 5. Eudamed andUnique Device Identification…
New editions of ISO 14971, Medical devices – Application of risk management to medical devices1 and its companion document ISO/TR 24971, Medical devices – Guidance on the application of ISO 149712 are being prepared by a Joint Working Group from…
Brazil is a large country with extensive and constantly expanding medical device regulations. This report explores the changes that are likely to have the greatest impact on companies’ regulatory strategies during 2018. Firstly, it sets out the official regulatory agenda…
The Medical Device Coordination Group (MDCG) was a key point of discussion and negotiation during the extended deliberations over the adoption of the new Medical Devices Regulation1 and In Vitro Diagnostics(IVD) Regulation2,which ran over no less than seven European Presidencies.The…
Introduction The new European Medical Devices Regulation (Regulation (EU) 2017/745, MDR)1 does not assign a specific legal status to three-dimensional (3D) printing and leaves unanswered the question of the applicable legislation in relation to this practice, which undoubtedly represents the…
Introduction Medical care is vital for life and the health of human beings, but waste generated from medical activities and production of medical devices represents a real problem to the natural and human world. Every day, relatively large amounts of…
Introduction Both cochlear implants and internal cardiac defibrillators fall within the definition of active implantable medical devices1. They are quite simply medical devices that are intended to be introduced surgically into the human body and that are intended to remain…
