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Partner, King & Spalding LLP
The U.S. Food and Drug Administration is continuously adapting and evolving its processes for the regulation of medical devices and medical device firms. In this session, we will cover the latest regulatory and legal updates affecting device firms, including statutory changes, new and revised guidance documents, and policy initiatives concerning both premarket and postmarket regulatory processes for devices. We will also review trends in FDA inspectional and enforcement activity. Keeping abreast of recent—and upcoming—changes and trends will help you adapt and prepare your organization for sustained compliance with FDA’s evolving status quo.
Director of Medical Device Unit at HungaroTrial CRO
Currently all new medical devices planned to be sold in European Union faces a huge challenge in the Conformity Assessment procedure to obtain the CE mark for Market Access. Medical Device Regulation is in force for all new products, introducing a high level of burden, which calls for action for the manufacturers starting from the first step of the design, requesting continuous effort until the product reaches the market, and even after that.
Medical Device Regulation was issued in 2017, and after one-year postponement, became fully applicable on 26 May 2021, causing an incredible high burden to the manufacturers who want to put the product to the EU market as well.
After 2 years since the application date, there are many bottlenecks in the procedure which are very important to know in advance in order to save time and money and unnecessary hassle for the manufacturers.
The speaker would present the most important challenges faced by the manufacturers, using his 17 years of experience as a Lead auditor and Certifier at one of the major Notified Body in Europe, as well as the last 5 years spent at a leading CRO in Central Europe.
Knowing these challenges would give for the manufacturers a huge advantage on the Regulatory Pathway when going to obtain the CE mark for the European Market
Sr. Human Factors Scientist, Research Collective
Human factors and usability engineering has garnered much attention from regulators and medical device manufacturers in recent years. It is becoming an increasingly common practice in an effort to make medical devices more usable, safer, and more effective for intended users.
As with any other community, there are topics that have received more attention than others in discourse. It can be difficult to keep up with the current thinking of the community. In this presentation, we will:
Target Audience
Vice President, RA & QA, Remidio Innovative Solutions
With the introduction of cutting-edge technology, SaMD and AI driven MedTech products in healthcare, notably in the form of medical gadgets, the healthcare sector has recently experienced a rapid shift. These ground-breaking innovations, which range from implantable cardiac devices to intelligent infusion pumps, Digital imaging, AI in disease detection, AI in precision medicine, etc. have changed patient care by providing previously unheard-of advantages and better results. But as medical devices become more computerized and interconnected, they also become more vulnerable to cybersecurity threats, posing serious problems for the healthcare ecosystem which may include but not restricted to – Patient Safety in a Digitized World, Data privacy, Adapting to Evolving Cyber Threats. In a constantly changing environment, the FDA regulates medical devices, works diligently to reduce cybersecurity risks, communicates responsibility with device manufacturers, hospitals, healthcare organizations, patients, security researchers, and other governmental organizations, and offers guidelines to help manufacturers create and maintain cybersecure products.
The FDA, on the other hand, exhorts manufacturers to monitor and assess cybersecurity vulnerability threats and to be proactive in disclosing vulnerabilities and countermeasures for the well-being to patients. The FDA may release a “safety communication” if an issue or vulnerability in software, hardware, or another element that potentially cause a risk has been identified. The significant subject of medical device cybersecurity is covered in this session, along with its profound implications for patient safety, Data Privacy regulatory compliance, and industry reputation. This session will address the importance of staying informed and taking preventative measures to protect these cutting-edge medical devices. Therefore, don’t miss this opportunity to learn more about why keeping current with cybersecurity developments and updates for medical devices is important for patient safety, data privacy, legal compliance, and maintaining public trust in the healthcare system, in addition to being good cybersecurity practice.
Key Learning:
Director, Clinical Affairs, Donawa Lifescience
The Medical Device Regulation (EU) 2017/745 (MDR) changed the European legal framework for medical devices and introduced very specific requirements concerning clinical investigations conducted in the EU compared with the significantly less detailed requirements in the pre-existing Directives for medical devices (93/42/EEC and 90/385/EEC).
The MDR harmonizes the basic requirements related to approving, conducting, and managing clinical investigations. In spite of this harmonization, important areas of variability among Member States remain concerning procedures for review and authorization by ethics committees, investigator qualifications, damage compensation systems, designation of a competent authority, and adverse event reporting and vigilance requirements. The MDR allows, and for some aspects requires, Member States to have national legislation in place. This leads to the need to check Member State websites. It is also necessary to understand the requirements of the relevant ethics committees. For these and other reasons, country selection continues to play a critical role in the conduct of clinical investigations in the EU.
Furthermore, the complexity of the MDR and the introduction of new requirements, and the establishment of the Medical Device Coordination Group (MDCG), composed of representatives of all Member States, which continuously issues and updates guidance documents, will also be discussed.
MedNet EC-REP, Germany
With the implementation of the new Regulation (EU) 2017/745 for Medical Devices (MDR) and the Regulation (EU) 2017/746 for In Vitro Diagnostic Medical Devices (IVDR) on 26 May 2021 and 26 May 2022, respectively, the application process for a clinical trial on medical devices or in vitro diagnostic medical devices should be adjusted in the Member States of the EU. The general procedure is outlined by the regulations; however, many details are defined in the 27 national laws.
We will demonstrate how complex the application procedure for Clinical Trials in Europe is. What is regulated by MDR/IVDR? What kind of studies exists and what are the differences. What national specifications are possible? As an example, we will use the legal situation in Germany. For this country we will explain how to apply for the different kind of studies according to the German Medical Device Law Implementation Act. In addition, we will mention what further requirements are hidden in the German law which Sponsors have to be aware of , if they start a study in Germany. As another example, we provide insight into the situation in Poland and present the national requirements in the application procedure.
The new term “Legal Representative” of the Sponsor for Clinical Investigations or Performance Studies was introduced EU-wide in the content of Clinical Trial for Medical Devices and In Vitro Diagnostic Devices (IVDs) in the MDR and IVDR. The Legal Representative (LR) is required in case that the Sponsor of a Clinical Investigation/Performance Study is established outside the EU. According to Art. 62(2) MDR or Art. 58(4) IVDR, respectively, shall be responsible for ensuring compliance with the sponsor’s obligations, and shall be the contact point for national authorities. National exceptions from this requirement are possible under certain circumstances. Until now, there is no further guidance available what is exactly the function of a Legal Representative. In addition, we need to have an eye on the 27 national laws. We would like to discuss the role as Legal Representative from our long-term experience as European Authorized Representative (EC-REP) for Medical Devices and IVDs in Europe and how we interpret the LR’s function.
FUSMobile, Inc.
All medical device manufacturers under the European Union’s Medical Device Regulation (EU MDR 2017/745) are required to develop and frequently update a Clinical Evaluation Report (CER). The intent of the CER is to provide regulatory authorities with a current view of the device’s clinical safety and performance and to demonstrate that the device fulfills the MDR general safety and performance requirements (GSPR). Article 61 and part A of Annex XIV of the MDR outline the requirements for the planning, conduct and documentation of the clinical evaluation, which also include the elements needed in the clinical evaluation plan (CEP), however, do not provide specific structure for the CER. Some guidance documents, such as MedDev 2.7/1 rev 4 and IMDRF DC EWG/N56FINAL:2019, exist but do not fully address the interpretation of the MDR requirements. There are some other resources available to assist in structuring the CER, for example – the Medical Device Coordination Group’s document MDCG 2020-13, which is a template to be used by the Notified Bodies to document the conclusions of their assessment of the clinical evidence presented by manufacturers in their CERs thus assists the industry to identify the expectations for the CER.
The CER should include an analysis of the clinical data to support that the device meets its safety and performance obligations. This analysis includes the collection, recognition, analysis, and review of the clinical data collected. The risk classification of the device will determine which review process will be utilized. For those seeking a CE-mark, permission to affix the CE-mark will not be granted unless the CER meets the MDR requirements.
All devices previously CE marked under the European Directives 93/42/EEC (MDD) or 90/385/EEC (AIMDD), legacy devices, are not exempt from the additional MDR requirements. All legacy devices are expected to comply with MDCG 2021-15 as related to post-market surveillance, market surveillance and vigilance. More current devices have tighter requirements under the MDR, especially as related to the clinical evaluation report. New control procedures have been implemented for high-risk medical devices, such as “scrutiny procedure” (Art 54).
The intent of this presentation is to pull together a variety of solid resources that will help guide you through the MDR CER process. Also, to assist you with streamlining and categorizing a process that is known to be complex so that you can more efficiently structure a CER. This session will provide the framework and insight needed to guide you through a successful submission.
Managing Director, ProMedoss
The 21st Century Cures Act was signed into law on December 13, 2016. The Act was designed to help accelerate medical product development and bring new innovations and advances to patients who need them faster and more efficiently.
Subsequently, over the past few years, FDA has established and further refined two programs intended to expedite the regulatory submission process for innovative medical devices, the Breakthrough Device Designation (BDD) and the Safer Technologies Program (STeP).
Both programs offer beneficial and potentially time saving opportunities for medical device companies. In this session I will provide an overview of the benefits of these programs and the criteria that must be met in order to receive a designation. Additionally, I will share some of the insights I have gained from personal experiences utilizing these program as well as insights from other regulatory experts.
Managing Partner, Hogan Lovells LLP
VP Operations & Clinical Affairs, Donawa Lifescience
The European Medical Device Regulation 2017/745 (MDR) which became applicable on 26 May 2021, introduced significantly increased requirements for Post Market Clinical Follow Up (PMCF). Manufacturers of devices which were CE marked based on the Medical Devices Directive, i.e. legacy devices, now to need to assess the usefulness of existing clinical data and may need to generate new clinical data to CE mark these devices under the MDR. . Manufacturers of devices which have been MDR-CE marked are facing the need to plan an efficient, financially sustainable PMCF data collection strategy. The MDR and associated guidance documents emphasize the level of clinical evidence which must be obtained during the PMCF phase to confirm device performance and safety after market entry. This presentation will present various options available for collecting PMCF data which range from clinical investigations to other studies based on registries, questionnaires, or other methods. Additional aspects that will be discussed include type of clinical data that need to be collected, study complexity of the various options, data collection methodologies, and country-specific considerations relevant to Ethics approval and data protection issues. These considerations will help companies develop a successful PMCF strategy in Europe.
Director of Medical Device Unit at HungaroTrial CRO
The presenter will summarize the most important aspects of the risk management regarding the MDR requirements,
especially emphasizing the stricter requirements of MDR which overrules some of the requirements of the standard,
creating need of special attention from the side of manufacturers even if they had a strong risk management system before.
Partner, King & Spalding LLP
FDA’s upcoming conversion from the QSR to the QMSR/ISO 13485: On February 23, 2022, the U.S. Food and Drug Administration published the long-awaited proposed rule to align the Agency’s Quality System Regulation (QSR) with the international standard for good manufacturing practices for medical devices, ISO 13485:2016. The new regulation, the Quality Management System Regulation (QMSR), will largely replace the QSR with the requirements of ISO 13485. Earlier this year, Dr. Jeff Shuren, the Director of FDA’s Center for Devices and Radiological Health, said that it is a high priority of the Agency to issue the final rule before the end of 2023, and FDA assigned a December 2023 date for the final rule in the federal government’s Unified Agenda of forthcoming regulations. The time is right to prepare for the upcoming transition from the QSR to the QMSR. This session will explore the current expectations regarding how and when the rule will be finalized and implemented, how it will impact both industry and FDA, and how you can prepare. Even firms already certified to ISO 13485:2016 will have to make adjustments to their quality systems, so don’t miss this critical update.
Sr. Human Factors Scientist, Research Collective
The following bodies require human factors and usability engineering when developing a new medical device:
It can be difficult to determine the requirements for just one of these markets, let alone all of them. Indeed, medical device manufacturers may (or may not!) understand the human factors requirements in their native markets, but they struggle to know how their efforts align under a foreign regulatory body. This presentation will cover the human factors engineering process and what medical device manufacturers need to know about the process according to the United States, United Kingdom, European Union, China, and international standards.
More specifically, the presentation will:
Target Audience
Clinical Research Manager, South Carolina Clinical Research
ISO 14155 is an international standard that provides guidelines for the conduct of clinical investigations of medical devices for human subjects. It outlines principles and practices to ensure the quality, safety, and effectiveness of medical devices throughout the clinical trial process. In the United States, the Food and Drug Administration (FDA) has its own regulatory requirement for medical device clinical trials, which aligns with ISO 14155 in many aspects but also has some specific requirements.
ISO 14155 applies to the planning, design, conduct, recording, and reporting of clinical investigations carried out to assess the safety and performance of medical devices for human use. The standard emphasizes the importance of ethical considerations, including obtaining informed consent from study participants and obtaining approval from competent ethics committees or institutional review boards (IRBs). ISO 14155 outlines the responsibilities of the sponsor, investigator, and other parties involved in the clinical investigation. It emphasizes the need for well-qualified investigators and sponsors to ensure the quality and integrity of the study. The standard provides guidance on ensuring the quality and integrity of clinical trial data. It covers data collection, monitoring, and reporting of adverse events and device deficiencies.
In the United States, medical device clinical trials typically require an Investigational Device Exemption (IDE) from the FDA before they can proceed. This is similar to the clinical trial application process in ISO 14155. The IDE application must include detailed information about the device, the clinical study protocol, and the plan for ensuring participant safety. Just like ISO 14155, the FDA requires IRB approval for the conduct of medical device trials. The IRB ensures that the study is conducted ethically and that the rights and safety of participants are protected. The FDA has specific requirements for data collection, reporting of adverse events, and device deficiencies. Sponsors and investigators are expected to adhere to these requirements to ensure the quality and accuracy of trial data. Medical device trials must comply with the FDA’s Quality System Regulations (QSR) for good manufacturing practices (GCMP) for medical devices. This includes ensuring that the device used in the trial is manufactured, stored, and distributed in compliance with these regulations. Depending on the classification of the medical device, successful clinical trial data may be submitted as part of a Pre-market approval (PMA) application or a 510 (k) clearance application to obtain marketing authorization from the FDA.
In this presentation, we will discuss the similarities and differences between the requirement of ISO 14155 and the FDA for the conduct of clinical investigations of medical devices for human subjects at the research site.
Endocrinology Associates & Remington Davis Clinical Research
Historically the FDA has been very divided and divisive regarding technology for medical diagnoses. This is in contrast to their whole-hearted support for technological advances in the realm of surgical interventions. This has been complicated by poor scientific rigor in identifying the best use case scenarios for medical device technologies due to a lack of understanding of the proper metrics to be used in research analytics. Translation of the data into clinically relevant applications has logically suffered as a result. Inconsistent understanding and usage of medical devices in the clinical setting has thus created a vacuum in the realm of further development of medical devices which is itself a negative feedback loop for advancing the use of device technology for medical diagnoses and indications. In this talk, I will explore these concepts and set up the dichotomy to debate: Either defend what the FDA is trying to accomplish with the necessary oversight or defund them and create an alternative solution.
Founder & Managing Director, ProMedoss
Over the past 30+ years, I have had the opportunity to work with many medical device companies, with some as an employee and with most as a consultant.
During this extensive period of time I had witnessed startups becoming stable companies and companies getting acquired for millions, while others vanished into thin air.
Is there a way to predict if a medical device company will succeed or fail?
Well, I am not a prophet and I do not have a crystal ball and it would be arrogant of me to say that I have the right answers. What I can do is share with you important lessons I learned throughout my career and provide you with examples from my experience as an expert in the regulation of medical devices, highlighting the dos and don’ts that may contribute to the success and failure of medical device companies from the regulatory perspective.