EU MDR 2017/745 will reduce the Risk of Medical Devices. Does MDCG got it Right?

Under the new European Union Medical Device Regulation (EU MDR), framed by Medical Device Coordination Group (MDCG), for each device manufacturers must have a documented risk management plan, identify and analyse the known and foreseeable hazards, estimate and evaluate the associated risks and eliminate or control those risks. In contrast with the MDD, the new EU MDR contains an explicit obligation in the new Article 10 (2), that manufacturers establish, document, implement and maintain a system for risk management. The detailed requirements of which are listed in the new Annex I Chapter I. Compared to MDD there is more emphasis on Post Market Surveillance (PMS) activities with the inclusion of European Databank or European Database for Medical Devices (EUDAMED) and mandatory submission of Periodic Safety Update Report (PSUR) to all the actors in the possession with the medical devices. A poll conducted by Aegis Lifesciences Pvt. Ltd, Ahmedabad, India concludes that the relevant annexures and sections in MDR 2017/745 have more emphasis on PMS, Vigilance, PSUR, EUDAMED, tracking, Implantation card etc. that are directed in regard to the safety of the Medical Device.

Current Trends in the Development and Use of Personalized Implants: Engineering Concepts and Regulation Perspectives for the Contemporary Oral and Maxillofacial Surgeon

The recently adopted Medical Device Regulation (MDR) has finally entered into force on 26 May 2021. As innovation and especially the advent of customized prostheses has deeply modified many surgical procedures in our discipline, it is imperative for the contemporary surgeon to become aware of the impact that the MDR will have on many aspects, including the choice of the manufacturer, the evaluation of the devices, point-of-care 3D printing labs, and medical software. In this paper, the authors tried to identify the cultural gaps in clinical practice that the MDR is supposed to fill. To achieve this purpose, a task force of experts was reunited, including CMF surgeons with direct expertise in medical software and 3D printing, mechanical and material engineers, facing the topic of the MDR from a multidimensional perspective. In this article, surgeons and engineers review many crucial aspects concerning the points of the regulation that mostly affect the field of implantable devices for the cranio-maxillo-facial skeleton. The result of interdisciplinary research is a paper aiming to provide surgeons with the knowledge on the fundamental processes of additive manufacturing, increasing the clinician’s awareness on the evaluation of a customized implant before surgery and on the underlying regulatory framework.

Health Software Product or Software as Medical Device

The number of software products in the field of health and medicine increases excessively. Self-tracking, fitness, health advice, dose calculation, and analysis of physiological data - apps are popular and commonly used. Some of the products are affected by the medical device regulation, consciously or unconsciously. For young entrepreneurs, it is difficult to recognize and understand the distinction between software as medical product and health software products. A product-related orientation guide could help start-ups to understand the difference and to find the right strategy for placing their product on the market. All relevant information were collected and analyzed. Input came from a systematic literature research, an evaluation of the CHARISMHA study and a consideration of the medical device regulation as well as the relevant standards (e.g. IEC 62304 and IEC 82304). The guide was adapted to the particular situation of start-ups and microenterprises, inter alia having regard to missing regulatory affairs competences. A product-related orientation guide for young entrepreneurs was developed, which helps to identify whether products are affected by the medical device regulation or not. The guide uses a few simple questions, and it allows the entrepreneurs to estimate the related effort. Furthermore, it provides an overview of relevant standards and needed competences for the chosen path. The guide brings certainty and can help young entrepreneurs to identify the upcoming workload at an early stage. Due to the decision tree concept, it is easy to adapt the product-related strategy and see the consequences. This might help entrepreneurs to find the right strategy for placing their product on the market. Nevertheless, field testing with the guide is necessary to validate its benefit.

Medical Device Regulation and the Proposed Therapeutic Products Bill: Devising a New Regime

Despite medical devices being integral to modern healthcare, New Zealand's regulation of them is decidedly limited, with repeated attempts at reform having been unsuccessful. With the Government now indicating that new therapeutic products legislation may be introduced before the end of the year, the article considers the case for change, including to promote patient safety, before analysing the draft Therapeutic Products Bill previously proposed by the Ministry of Health, and on which any new legislation is expected to be based. It concludes that, while the proposed Bill is a step in the right direction, introducing regulatory oversight where there is currently next to none, there is still significant work to be done. In particular, it identifies a need to clarify whether the regime is indeed to be principles-based and identifies further principles which might be considered for inclusion. It further proposes regulation of cosmetic products which operate similarly to medical devices to promote safety objectives, while finding a need for further analysis around the extent to which New Zealand approval processes should rely on overseas regulators. Finally, it argues that, in an area with such major repercussions for people's health, difficult decisions around how to develop a framework which balances safety with speed to market should not be left almost entirely to an as yet unknown regulator but, rather, more guidance from Parliament is needed.

When Is Software a Medical Device? Understanding and Determining the “Intention” and Requirements for Software as a Medical Device in European Union Law

The role of software in society has changed drastically since the start of the twenty-first century. Software can now partially or fully facilitate diagnosis and treatment of a disease, regardless of whether it is psychological or pathological. Consequently, software plays a role comparable to medical equipment with a physical footprint. Understanding when software as a medical device must comply with applicable rules is vital for both manufacturers and regulators. We therefore examine the Medical Device Regulation to expand on the notion of intention, as this is the key basis for the classification of medical devices. Finally, we develop objective criteria that software must fulfil to be considered a medical device under European Union law.