Due to COVID-19, regulatory agencies are relaxing guidelines and shifting priorities to address shortages in diagnostics and respiratory devices.
Overview
The current pandemic led to the one-year delay of the new European Union (EU) Medical Device Regulation (MDR), allowing authorities and manufacturers to continue under current procedures. This delay also provides more time for the European Commission to issue guidance documents. Despite this deadline extension, manufacturers should where possible continue with current plans to certify devices under MDR, as Notified Bodies (NB) are continuing to be designated under MDR.
During uncertain times, it is necessary to understand current regulations and what it means for your development programme.
In this webinar, our regulatory and clinical experts will discuss the new challenges arising from the COVID-19 crisis and how to best navigate the regulatory landscape moving forward.
- Impact on Notified Bodies (NBs) including the one-year delay of MDR, site audits and associated changes within the EU (UK & Brexit, Switzerland, Turkey)
- Recap of changes to Quality Systems such as the impacts to third party internal audits and supplier audits
- Considerations for EU and U.S. clinical studies including: CE marking versus U.S. approval processes, emergency use authorisation and flexibility in timing and sterilisation concerns
Target audience
Medical device and IVD manufacturer personnel from R&D, Clinical Operations, manufacturing, Quality Assurance, Regulatory Affairs, Executive/Management and Sales/Marketing
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Presenters
Sarah Sorrel
Sarah has more than 30 years' experience of medical device regulation and clinical trials with an emphasis on emerging technologies. She is founder and President of MedPass International, the leading European CRO and consultancy for the development and market access of new medical technologies.
Following early experience gained in a French start up that went on to receive PMA approval in the US, she created MedPass 28 years ago to assemble teams of highly skilled regulatory and clinical experts that could be outsourced to start-up companies enabling them to achieve their goals cost efficiently. During this time, MedPass has successfully helped over 1,000 medical device companies worldwide bring new technologies to the EU market. Sarah is a recognised expert in EU medical device regulation and clinical investigations.
She has spoken at and chaired conferences organized by RAPS and Medtech Ireland. She has written recent articles for industry trade journals. Sarah is American and holds a degree in Engineering and Applied Science from Yale University.
David Francis
David has over 20 years’ experience in medical device regulation including at Director level in industry and 9 years at BSI Notified Body where he held the position as Global Head of Active Implantable Medical Devices (AIMDs). He also worked as Senior Technical Specialist at LRQA and TÜV SÜD Notified Bodies.
David’s expertise includes assessment of Design Dossiers/Technical Files and performing technical audits for devices as part of the CE marking approval process for Europe. Technical assessments involve a review of compliance with the essential requirements of the Medical Devices Directive and Active Implantable Medical Devices Directive, including verification & validation testing, risk management, clinical evaluation, post market surveillance (including PMCF), technical standards, packaging integrity & transit testing, product lifetime, shelf life, wireless telemetry and software life cycle processes.
David is a registered with FEANI as European Engineer, a Chartered Engineer, Fellow of the Institution of Mechanical Engineers and Member of the Institution of Engineering and Technology.
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Angela Brown, B.S.
Angela has over 20 years of regulatory affairs and quality assurance experience with various products in the medical device industry specialising in international regulatory affairs working with universities, start-up and blue chip companies. Her expertise reflects her ability to successfully navigate country specific requirements by providing strategic global regulatory strategies and submissions bringing new and existing products to the marketplace outside the US including EU, Canada, South & Latin America, Middle East, Asia, and Africa, as well as the US.
She is experienced in transitional regulatory activities to handle the ever-changing global regulatory environment. Angela has a comprehensive knowledge of the regulations for the preparation and writing required for global medical device submissions including EU Technical Documentation (Technical Files/Design Dossiers), Canadian Licensing and Submissions, TGA Technical Documentation, International Product Dossiers, and JSTED, as well as US premarket submissions. Additionally, her expertise in quality assurance provides quality management system alignment as additional geographic regions are incorporated, specifically in post market activities including complaint management, adverse event reporting and recall management.
Angela has held various levels of responsibility in regulatory and quality throughout her career prior to joining ICON in 2018. She is an active member of the Regulatory Affairs Professional Society (RAPS), The Organization for Professionals in Regulatory Affairs (TOPRA), and holds a B.S. in health science from Campbell University.