David
May 8, 2018 - Hollywood FL USWorld Compliance Seminars
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Phone:347 282-5400
Live Webinar Understanding and Applying the New EU Medical Device Regulations (EMDR) Description The European Parliament just adopted the Medical Devices (MDR) and In vitro Diagnostic Medical Devices (IVDR) regulations. The adoption marks another hallmark event in the global medical device identification initiative to achieve standardized medical device identification, improved device quality and better patient safety. The new regulations also mean time is ticking for medical device manufacturers selling devices in the EU to comply. After two decades of work, the EU’s new medical device and in vitro regulations are nearing their final approval stretch. The European Council and the European Parliament voted on the regulations effective May 2017. Manufacturers will have three years to comply with the MDR and five years to comply with the IVDR. The two documents, which total 566 and 477 pages respectively, completely revamp the EU’s existing regulatory framework. The MDR will require risk management and quality management systems, the use of unique device identifiers and tighter control over distribution chains. One of the most significant provisions in the EU’s new MDR restricts the types of clinical data manufacturers can use in clinical evaluation reports. Previously, clinical data for new devices have been drawn mainly from available literature for equivalent or partially equivalent devices. By contrast, the MDR requires manufacturers to perform their own clinical evaluations for higher-risk Class III and implantable products. The evaluations must include an analysis of the relevant scientific literature, an analysis of the results of all available clinical trials, and a consideration of any currently available alternative treatment options. But there is an exception for Class III devices that have merely been modified and are substantially equivalent to currently marketed version. Existing clinical evaluations for equivalent products can be used for Class II devices, but only if the data were collected according to the MDR’s standards. Manufacturers relying on equivalence will need to ensure they have access to relevant post-market surveillance data — especially clinical data — and fill in any gaps in collection or analysis. Another key change in the MDR is that sufficient clinical data need to be presented for each product, clinical claim, and clinical indication. Under the EU’s previous device regulations, manufacturers often use a mix of data that was biased toward specific products, clinical claims, and/or clinical indications. The MDR provides that if no additional data are being generated for specific claims and indications, those claims and indications will need to be dropped. Many companies have not been writing clinical evaluation reports in line with the MDR’s requirements or the associated guidance. These companies will need to essentially start over and develop all-new procedures. For example, in their quality management systems, manufacturers should include a process for writing clinical evaluation reports, along with criteria for deciding when clinical studies are needed and what they should focus on. A QMS also should include templates and guidance on how to write clinical evaluation plans and collect the appropriate data. In addition, manufacturers should communicate early and often with their notified bodies to ensure that their clinical data will be accepted. The New EU MDR — Are You Really Ready? Your Roadmap to World-Class Implementation of Europe’s New Medical Device Regulation. You have 3 years to become compliant. Why Should you Attend • Device manufacturers looking to abide by the EU's new medical device and in vitro diagnostic regulations take note: The EU's overhaul of its framework is here • Scope & Plan, GAP assessment, Portfolio analysis, Global Impact Assessment are just some of the steps on the road to MDR implementation that must be addressed to ensure compliance • All notified bodies will need to reapply for certification • The EU’s medical devices database, Eudamed, will now contain UDI data, single registration numbers for all economic operators, accreditation and designation data for notified bodies, and more • Device makers will have to appoint a specific person to take responsibility for regulatory compliance • Turn-around time for reporting adverse events will drop from 30 days to only 15 days • The EU standard EN ISO 13485, recently updated to incorporate changes made in 2016, will likely have to be revised again • Update you on the current state of the legislation — What does the recent political agreement mean? • Highlight the areas of greatest risk and opportunity • Provide models for how companies can assess their readiness and prepare • Outline a clear path to compliance • Much more... Objectives Of the Seminar • The new Medical Device Regulation (MDR) and In Vitro Diagnostic Device Regulation (IVDR) present the first major changes to the EU medical device regulatory environment in more than 20 years. • The two new regulations will replace the three existing Medical Device Directives • The MDR will impact ALL device manufacturers • Major changes to clinical evidence requirements • Own Brand Labeler (OBL)" manufacturers will practically be made history-All OBL devices will need to have full Technical Files (art. 8.2, art. 8.4), as well as clinical data (art. 8.2). • Major labeling changes: Unique Device Identification (UDI) codes must be included on all medical device labels; other significant changes to labeling requirements in the MDR will also need to be addressed • Tighter control over distribution chains • MDR scope is expanded to include new product lines • Changed role for Notified Bodies • Authorized Representatives’ liability increases • UDI requirements in the MDR and IVDR • Timelines • Differences between US UDI requirements and the MDR and IVDR requirements • Status of the implementation and EUDAMED systems • Solutions, processes and best practices we see in the industry as companies begin to understand and prepare for MDR and IVDR and other UDI initiatives • Live Q&A and interactive session Areas Covered • In terms of implications for CE Marking, certificates issued prior to final implementation of the MDR in late 2019 or early 2020 will have a maximum validity of five years • All CE Mark certifications issued before implementation of the new regulations will automatically expire four years after the new regulations come into force • The EU has up-ended its entire medical device oversight system — replacing its three current guidance directives with two massive regulations that bind device makers to a variety of new requirements Who will Benefit • Clinical Operations • Regulatory Affairs Management • Quality Assurance Management • Clinicians • Distributors • Manufacturing Operations/Supply Chain • Regulatory Affairs Specialists/SME’s • UDI Specialists/SME’s David R. Dills, Global Regulatory Affairs & Compliance Consultant, currently provides global regulatory affairs, compliance and quality consultative services for early-stage and established Class I/II/III medical device, including combination products, In Vitro Diagnostics, and biopharmaceutical manufacturers in multiple medical specialties and therapeutic areas on the global landscape, and has an accomplished record with more than 27 years of experience in the areas of Regulatory Affairs, Compliance and Quality Systems. |$179 One Dial-in One Attendee|$279 One Dial In - Max 10 attendees|$695 Multiple locations upto 5 dial in|$249 Available within 24 hrs after|$299 CD/DVD will be dispatched after https://worldcomplianceseminars.com/webinardetails/380