Medical Device Regulation Research Articles

Best practices for disinfection in dental settings: insights from Italian and European regulations.

Disinfection practices in dental settings are fundamental to clinical safety, playing a pivotal role in preventing cross-infections and protecting the health of patients and healthcare professionals. This article examines the key components of effective disinfection, based on evidence-based protocols developed by international organizations such as the WHO and the U.S. CDC, alongside European and Italian regulatory standards. Dental instruments require stringent sterilization by autoclave or chemical methods, while high-level disinfection is essential for non-sterilizable items. Clinical surfaces require routine biocidal treatment tailored to microbial hazards and material compatibility. The European Biocidal Products Regulation and the Medical Devices Regulation provide critical oversight, ensuring product safety and effectiveness while preventing resistance. Antiseptics also play a vital role in oral care, with applications ranging from infection prevention to the treatment of periodontal disease, and are governed by strict regulatory frameworks. Disinfection effectiveness is significantly affected by factors such as microbial load, presence of biofilm, pH, temperature and biocide exposure time. Preventing bacterial resistance requires appropriate germicide selection, adherence to manufacturer protocols, robust sterilization and cleaning procedures. In addition, the increased use of disinfection during public health emergencies highlights the need for adaptability to mitigate evolving risks. Regular audits, biological tests, and training for healthcare personnel ensure the consistent application of these rigorous protocols. By integrating international and national standards, dental facilities achieve a uniform approach to hygiene and safety, advancing public trust and compliance. This article highlights the imperative for ongoing research and dissemination of best practices to enhance infection control in dental care environments.

Exploring key stakeholders’ perspectives on integrating the EU AI Act with the MDR for certifying AI medical devices

AbstractArtificial Intelligence (AI) algorithms are transforming healthcare by advancing the capabilities of medical devices. These algorithms can now analyze X-ray images to help detect and interpret medical conditions, particularly in radiology and pathology. The growing use of AI in medicine highlights the importance of strict regulations to prioritize patient safety during the development and deployment of AI in medical devices. Despite extensive research, there are limited empirical studies on stakeholders’ perspectives regarding the challenges of implementing AI regulatory frameworks alongside existing legally binding regulations specific to medical devices. This study uses semi-structured interviews to explore the perspectives of key stakeholders, such as regulatory bodies and medical device manufacturers, to understand the potential implications of integrating the European Union Artificial Intelligence Act with the Medical Device Regulation to certify AI-embedded medical devices. Through inductive-thematic analysis and adopting activity theory to further synthesize the interviews, the findings reveal stakeholders’ challenges, including uncertainty about implementing different regulations, resource limitations, and the potential impact of complex regulations on healthcare quality. Additionally, the results indicate that key stakeholders did not explicitly identify the absence of a comprehensive ethical framework for AI-enabled medical devices in both regulations as a major challenge. This underscores the need to develop a harmonized ethical framework for certifying AI used in healthcare.

The EU AI Act’s Impacts on Digital Health

Abstract The European Artificial Intelligence Act (AI Act) has profound implications for technological innovation in the medical and health care sector, transcending the boundaries of existing legal frameworks such as the Medical Device Regulation (MDR) and the General Data Protection Regulation (GDPR). This paper examines basic regulatory choices of the AI Act relevant for the field of digital health innovations by contextualizing its main goals, key obligations, and addressed actors. In light of these considerations, we present a scoping literature review that identifies potential regulatory challenges for stakeholders engaged in research, innovation and healthcare. Building on this, we point to concepts and methodologies to overcome such challenges in a way fostering innovation while realizing key constitutional and societal interests at the same time.

Regulatory Requirements for Medical Devices Based on Artificial Intelligence

Abstract Artificial intelligence is rapidly transforming healthcare, yet in Europe, there are no standardized regulations for AI-based medical devices under the Medical Device Regulation. This gap necessitates independent compliance verification by medical device manufacturers. This paper addresses the regulatory void by proposing a comprehensive training concept. It equips manufacturers with essential artificial intelligence knowledge and outlines current market introduction challenges. Through pre-tests and training sessions, the concept's efficacy will be assessed and refined. In summary, this work offers insights into AI's transformative potential and regulatory hurdles in healthcare, paving the way for improved standards and practices.

Impact of the European proposal to restrict PFAS on modern medical technology and treatment options

Abstract Functionality of state-of-the-art medical devices often depends on high-end materials. Today, a large spectrum of medical devices like heart valves, vascular grafts, sutures or endoscopic devices consist of or incorporate fluoropolymers like polytetrafluoroethylene (PTFE). Fluoropolymers offer unique mechanical, electrical and chemical properties. Based on their chemical constitution, fluoropolymers are assigned to the group of per- and polyfluorinated substances (PFAS). The aim of the current restriction proposal within Europe (EU) is to limit and/or fully ban the persistent PFAS substances known as forever chemicals. The restriction proposal concerns all PFAS substances beyond further subdividing and evaluating their hazardous potential and with just short-term derogations depending on the application. The consequences of the impending restriction proposal on PFAS is shown from a medical device industry viewpoint. Literature data on annual material consumption and supply chain are collected and evaluated, especially pointing to future problems assuming an entry into force of the pending restriction proposal. Furthermore, the short derogation times are contextualized with current timelines of Medical Device Regulation (MDR) approval processes to highlight the impact on product availability assuming a PFAS ban. Selected examples of affected products illustrate, how patient treatment options are limited by the PFAS restriction. It can be clearly shown that the PFAS restriction will critically affect the medical device sector through collapsed supply chain and insufficient derogation times for product approvals, thus limiting the availability of medical products and setting back the gold standards in medical treatment.

The Current Status and Suggestions of Registration Quality System Audit for Entrusted Production According to Shanghai Medical Device Regulation of Marketing Authorization Holder

This study expounds on the current status of the registration quality system audit for entrusted production in the past three years in accordance with Shanghai's medical device regulations for marketing authorization holders (MAH). Through sorting and analyzing typical non-conformities, highlighting the main responsibilities of registrants, and clarifying the obligations and rights of relevant parties. Meanwhile, it also provides a certain useful reference for medical device marketing authorization holders and relevant regulators.

Regulatory issues related to the use of sodium hypochlorite solutions in endodontics.

To assess the regulation of sodium hypochlorite (NaOCl) solutions for endodontic usage in some of the world's main dental markets, in view of the European Union's recent move to classify antimicrobial root canal irrigants as high-risk devices under their Medical Device Regulation (MDR). The authors consulted legal texts available online and communicated with local health authorities wherever necessary to assess into which medical device category NaOCl solutions intended for endodontic application were subsumed. Furthermore, it was investigated whether there were sources outside the dental market to obtain NaOCl solutions for root canal treatments. Upon completion of this text (mid 2024), NaOCl solutions for root canal irrigation had not been classified in the US and Canada, whilst in the European Union, they had just been upgraded to high-risk medical devices, with all the consequences for the dental supply market. This MDR rule was adopted by the EU's close trading partners, the United Kingdom, Switzerland and Turkey. In Japan, the legal hurdles were already high for manufacturers and importers of endodontic NaOCl solutions. Conversely, in China, these solutions were down-graded from a high-risk to a medium-risk status in 2017. A low-medium risk category was applied in the other countries under investigation, that is, Australia, India and Brazil. In some countries there was a possibility for dentists to procure plain NaOCl solutions from pharmacies. An alternative route to avoid buying NaOCl from dental suppliers was to use (household) bleach solutions for root canal irrigation wherever this practice was not prohibited explicitly. The legal situation to produce, import and use NaOCl solutions for root canal irrigation differs vastly around the globe. A sensible approach to regulate (yet not over-regulate) endodontic NaOCl solutions appears to be timely and necessary.

Safety notices and registry outlier data measure different aspects of safety and performance of total knee implants: a comparative study of safety notices and register outliers.

Safety notices for medical devices such as total knee arthroplasty (TKA) implants may indicate problems in their design or performance that require corrective action to prevent patient harm. Safety notices are often published on national Ministries of Health or regulatory agencies websites. It is unknown whether problems triggering safety notices identify the same implants as those identified by registries as "outlier." We aimed to assess the extent to which safety notices and outlier identification in registries signal the same or different TKA implants. The CORE-MD tool, an automated web scraper tool, was used to collect safety notices related to TKA implants on 13 national Ministries of Health websites and regulatory agencies. Safety notices were defined according to the Medical Device Regulation (MDR) as "a communication sent by a manufacturer to users or customers in relation to a field safety corrective action." Identified TKA outliers, defined as having a significantly higher revision risk than other comparable TKA implants, were extracted from registry reports. 787 safety notices for 38 TKA implants and 35 TKA outliers were identified, together identifying 47 unique TKA implants. 26 (55%) TKA implants had safety notices and were also outliers, 12 (26%) TKA implants had only safety notices, and 9 (19%) were outliers only. TKA implants with safety notices only had similar types of problems to TKA outliers with safety notices, with "Manufacturing/Packaging/Shipping" problems being most frequent (44%). Cumulative revision risks (1/5/10 years) were lower for TKA implants with safety notices only than for TKA outliers with safety notices. 55% of the TKA with a safety notice were identified as outliers in the registry, whereas around 25% of TKA outliers are not the subject of publicly released safety notices, with safety notices pointing to TKA implants not identified by registries as potentially having a higher risk of failure. This suggests that safety notices and registry outlier data measure different aspects of safety and performance.

Information Disclosure, Medical Device Regulation, and Device Safety: The Case of Cook Celect IVC Filters.

Although medical devices are widely used in clinical practice, clinicians and the public have limited access to information on how devices are tested, regulated, and used, posing challenges to patient safety. This article uses Cook Medical's Celect inferior vena cava (IVC) filter, a medical device used for prevention of pulmonary embolism, as a case study of the transparency gap in medical device regulation. Recently unsealed court documents from litigation related to Celect reveal that the device's clinical study protocol did not follow U.S. Food and Drug Administration (FDA) guidance for IVC filter testing and that study outcome definitions for IVC perforation had lower sensitivity for detecting adverse events than those recommended by professional societies. Furthermore, a comparison of court documents and the public record indicates that adverse events and patient deaths were misreported to FDA reviewers and were inaccurately reported in the published literature and on the device label, providing patients and clinicians with inaccurate information about the device's safety. The Celect IVC filter case demonstrates the need for regulatory reforms to ensure that critical safety data are accessible to the FDA, clinicians, and patients to inform decision making.

The application study of harmonization code in medical device adverse event reporting

BackgroundThe reporting of adverse events in medical devices (MD) is a starting point of post-market surveillance and the most common source of initial safety signals. Because MD adverse events (AE) occur globally and involve high-profile international public health crises, international regulators implanted standard codes for MDAE reporting. This study aimed to assess the application of MDAE terminology and codes by providing examples of virtual events.MethodsAn online survey was conducted among participants of the MD Training Program for Regulatory Authorities which provide International Medical Device Regulators Forum (IMDRF) adverse event terminology and codes, and six virtual MDAE cases.ResultsAll 29 of the 72 participants were regulators. In all cases, most participants selected the broad (level 1) codes rather than the detailed (level 2 or level 3) codes. While responders selected a variety of codes for all annexes in case 1, over 50% of responders selected the intended codes in case 6. The codes for cause investigation were chosen more frequently than other annexes for device problem, components, and health effect. No differences were observed in code selection amongst different stakeholders.ConclusionsWe identified the diversification in terminology and code selection for reporting MDAEs.

Cybersecurity Framework for Synthetic Data in Training Medical AI

Abstract The development of medical artificial intelligence is dependent on the availability of vast quantities of data, a considerable proportion of which is medical data containing sensitive information pertaining to the health and well-being of patients. The use of such data is subject to extensive legal regulation and is further hindered by financial and organisational constraints, which can result in limitations on accessibility. One potential solution to this problem is the use of synthetic data. This article examines the potential for their use in light of cybersecurity requirements derived from horizontal and sectoral EU legislation. The outcome of this analysis is that EU legislation does not contain specific regulations on the use of synthetic data. Consequently, it cannot be concluded that there is any prohibition on their use. Moreover, while the Medical Device Regulation (MDR) contains some general requirements for cybersecurity, these are further specified by the provisions of the AI Act. It is important to note, however, that the AI Act will not apply to Class I medical devices, which are subject only to the MDR. Furthermore, only indirect obligations within the scope under consideration can be derived from the horizontal regulations, which will apply in a limited number of cases.

AI Robotics in Healthcare Between the EU Medical Device Regulation and the Artificial Intelligence Act

AI Robotics in Healthcare Between the EU Medical Device Regulation and the Artificial Intelligence Act

Accessibility engineering in the mhealth industry - A multi-case study

Abstract Medical apps, i.e. apps that fall under the EU Medical Device Regulation (MDR), are increasingly becoming a relevant part of healthcare in European countries. This is particularly evident in the numerous partnerships between app vendors and insurers as well as in the launches of national reimbursement programs. However, when it comes to enabling as many patients as possible to benefit from the medical advantages associated with the use of these apps, funding is only one part of the equation. It is up to the app vendors to develop barrier-free user interfaces so that people - regardless of individual characteristics such as cognitive abilities, physical limitations or language skills - can interact successfully with the app. Little is known about how these companies approach the topic of accessibility, what challenges they face and how big the impact of medical device legislation and other regulations on accessibility is. Against this background, we are undertaking a case study in several companies offering apps on the German market that are certified as medical devices and targeted at patients. Through interviews with employees with various roles (e.g. business, engineering, design) we are aiming at reconstructing the development processes of the apps with a focus on accessibility. We plan to expand the results by interviews with experts, e.g., in the area of MDR conformity assessment. 20 interviews in four companies have revealed that accessibility only plays a minor role during development. As a result, the topic is not systematically addressed, but only a few features are implemented. The app’s compatibility with screen reader or voice control was not explicitly addressed in any of the companies. There was also no deliberate involvement of people with disabilities in user studies. The preliminary results also indicate that the influence of medical device legislation on the implementation of accessibility is negligible. Key messages • User interface accessibility has a very low priority in the mhealth companies we have examined so far. • The current regulations are not sufficient in enforcing the basic implementation of accessibility features requiring more guidance and detailed regulations, given our sample of companies.

Development of an assessment process for digital medical devices in Austria

Abstract Issue/problem Digital medical devices have experienced a rapid development in recent years and are playing an increasingly important role in healthcare. These devices offer numerous benefits and can improve patient care. However, despite their potential benefits, the use of digital medical devices also poses risks and regulation from governmental side is needed from a Public Health Perspective. This is why some countries already implemented assessment processes for Digital Medical Devices (e.g. Germany and France) leading to the question how such a process could be established in Austria too. Description of the problem While digital medical devices must fulfil requirements set by the medical device regulation to enter market, several other aspects are of interests when offering digital medical devices in routine care. These include e.g. medical effectiveness, data security and interoperability. The objective of the ongoing pilot project is to develop a process for the assessment of quality-assured digital medical devices in Austria in 2024. For this, a combination of literature research, interviews and workshops with relevant stakeholders is used in order to gain all necessary information. Process and assessment criteria will be tested and revised in a pilot phase with several digital medical devices. Results At the end of the project, an assessment framework as well as a potential evaluation process will be designed in accordance with relevant stakeholders. Moreover, legals aspects and the potential integration into the austrian health telematics infrastrucutur will be assessed. This will form a basis for implementing digital medical devices within the austrian healthcare system. Key messages • The result of this project aims to build the basis for implementing an evaluation process for digital medical devices in Austria. • The establishment of an evaluation process for digital medical devices supports the integration of quality assured digital medical devices in healthcare.

Quality evaluation of field safety notices of medical devices, across EU and non-EU countries

Abstract Introduction The EU Medical Device Regulation 2017/745 (MDR; article 87) requires device manufacturers to report to the relevant authorities any serious incident and any corrective action undertaken, through Field Safety Notices (FSN) whose content must be consistent in all Member States. Before MDR, due to the lack of harmonized global standards for reporting, FSNs were published independently by each country with different formats, styles, nomenclatures and languages. This heterogeneity makes it challenging to use such historical data for trend analysis in post-market surveillance (PMS). Purpose 1) To assess the quality of the FSNs issued by EU or non-EU national authorities for analysing historical trends. 2) To group countries based on such quality, and test for differences between EU and non-EU countries. Methods As part of the CORE-MD project coordinated by the ESC, all FSN information publicly available as HTML text (excluding linked PDFs) was retrieved automatically from national authorities’ websites, using the CORE-MD PMS tool [1]. For each FSN, a score was assigned to each field of interest (1 or 2, according to importance for building trends) (see Figure 1), and a Percentage Score (PS) computed as the % of the ratio between the scores’ sum and the maximum possible score (10). Based on PS, FSNs were categorized as Excellent (≥90), Very Good (80≤PS<90), Good (70≤PS<80), Medium (60≤PS<70), or Unqualified (<60). For each country, the distribution of FSN categories was computed. Hierarchical Agglomerative Clustering (HAC) was used to group countries based on their similarities, and differences between EU and non-EU countries were assessed by Mann-Whitney U test. Results 126,405 FSNs published before 31/12/2022 were retrieved and analyzed. The % of FSN in which each field was available is shown by country in Figure 1. Manufacturer and Device were clearly described, but more detailed device information was often absent. The Description, with the reason for publishing the FSN, and the Device Category, allowing nomenclature categorization, were provided only by a few countries. The % of FSNs in each quality category is reported in Figure 2: only Italy provided some FSNs (31%) classified as Excellent. The HAC analysis identified three clusters: "high-quality FSNs" (Czechia, Denmark, Italy, Sweden, the Netherlands, and the USA), "moderate-quality FSNs" (Australia, Canada, Greece, Ireland, Latvia, Slovenia, Spain, and the UK), and "low-quality FSNs" (Croatia, Estonia, France, Germany, Poland, and Portugal). There was no difference between EU and non-EU countries. Conclusions A significant discrepancy was observed in the quality of FSNs retrieved from different countries, highlighting the difficulty in using such data to analyse trends, for example in reports of cardiovascular devices. This study reinforces the need for a global minimum reporting standard, to facilitate more effective PMS.Figure 1Figure 2

PHSOR07 Presentation Time: 9:30 AM: In-House Developed Medical Device Software BiCycle for Automated BT Treatment Planning, Compliant with the European Medical Device Regulation (MDR)

PHSOR07 Presentation Time: 9:30 AM: In-House Developed Medical Device Software BiCycle for Automated BT Treatment Planning, Compliant with the European Medical Device Regulation (MDR)

Recent regulatory developments in EU Medical Device Regulation and their impact on biomaterials translation

AbstractWe envision this work to assist researchers and medical device developers (beside other stakeholders) to better understand biomaterial‐based medical device development and its approval process proposed by the new MDR and IVDR in the European Union, as more complex biomaterials emerge, with the MDR reflecting the progress in biomaterial discoveries. Additionally, insufficient international harmonization in regulatory laws and poor‐quality data reporting contribute to the problem. This review describes the possible reasons for a slowing biomaterials translational trend observed over the past decades, focusing on the European Market, and suggests a feasible approach for biomaterials‐based medical device translation into the clinic. Suitable solutions to upgrade biomaterial translation to the clinic have not yet been provided by the field: no additional hurdles should be imposed for researchers, clinicians, the medical device industry, and insurance companies, which all should collaborate on bringing innovative solutions to patients. The new MDR and IVDR represent a substantial advancement in ensuring patient safety and reflect a major step forward in healthcare. However, they should not constrain innovation in biomaterials‐based medical device development. Incorporating reverse engineering from patient safety and a ‘safe by design’ (SbD) strategy early into medical device development might lead to a smoother and successful approval process. A solid R&D phase, with an emphasis on device safety and performance assessment, is fundamental to ensure an effective transition into the clinic. We offer an overview of the recently implemented regulations on medical devices and in vitro diagnostics across the EU, describing a shifting paradigm in the field of biomaterials discovery. As more complex biomaterials emerge, suitable regulations will be necessary to keep bringing safe and well‐performing medical solutions to patients.

Modernizing Medical Device Regulation: Challenges and Opportunities for the 510(k) Clearance Process.

Nearly all medical devices reviewed by the U.S. Food and Drug Administration (FDA) are authorized via the 510(k) clearance process. Established in 1976, this review pathway bases authorizations on the comparability of new devices to previously authorized devices ("predicates"). This evaluation usually does not require clinical evidence of safety and effectiveness. Advocates of the 510(k) clearance process tout its support for device innovation and rapid market access, and critics of the 510(k) clearance process express that it may inadequately protect patient safety. In September 2023, the FDA issued 3 guidance documents that, if finalized, would significantly change medical device regulation. This article provides clinical and regulatory context for the proposed guidance documents, which focus on predicate selection, clinical testing requirements, and implantable devices, and identifies opportunities for further reforms that promote transparency and patient safety.

Energy-Based Medical Devices in Plastic Surgery: A Comparison of FDA-Approved Indications to Advertised Claims.

Lasers and energy-based devices are commonly employed in aesthetic medicine. In the United States, the FDA regulates lasers as medical devices, restricting marketing to approved indications and making off-label claims illegal. Despite this, no comprehensive analysis of off-label marketing prevalence exists. The authors of this study aim to compare the FDA-approved indications for 2 popular aesthetic lasers to their online advertising claims. Additionally, they seek to educate aesthetic providers on the current regulatory restrictions surrounding off-label advertising. FDA-approved indications for 2 lasers-helium plasma dermal resurfacing and 2940 nm fractional erbium-doped yttrium aluminum garnet-were obtained from the publicly available Establishment Registration & Device Listings Database. Online advertisements regarding the capabilities of each laser were collected from practice websites in the United States. Our analysis of 100 online claims for each laser revealed that more than half of the websites advertising helium plasma (n = 59) and 44 websites advertising fractional lasers made at least 1 off-label claim. Both plastic surgeons and nonplastic surgeons made at least 1 off-label claim, with no statistically significant difference between the groups. Despite FDA regulation of medical devices, online advertising regarding the indications and capabilities of popular medical lasers varies widely. Patients who seek information regarding aesthetic laser treatments may encounter inaccurate and differing claims for these treatments, potentially leading to false expectations and poor patient outcomes.

A Blueprint for Clinical-Driven Medical Device Development: The Feverkidstool Application to Identify Children With Serious Bacterial Infection

Clinical decision rules (CDRs) integrated into applications enhance diagnostic and treatment prediction support for clinicians, necessitating CE-mark certification to enter the European market. We describe the development of a CDR as a medical device, focusing on challenges from a physician's perspective exemplified by the Feverkidstool (FKT), a validated CDR for febrile children. We pursued a local process, aligned with the CE-marking process, to develop the FKT as in-house developed device. We aim to provide a blueprint for colleagues.Medical device development, conform the Medical Device Regulation and performed by a multidisciplinary team, encompassed five stages: market scan, design, production, verification and validation and conformity assessment. Regulatory processes were continuously updated. The market scan identified a need for the FKT compared to existing applications. A prototype was designed in stage 2, further adjusted and improved based on the qualitative and quantitative results of stage 2-4. Lastly, stage 5 confirmed FKT's performance and safety. Medical device development presents challenges for physicians, requiring collaboration for technical, regulatory, and financial expertise. Multidisciplinary teamwork also poses challenges, including uncertainties regarding responsibility and timelines. After CE-certification, adapting to evolving needs and ensuring data privacy highlights the ongoing nature of medical device development.