2 Day Workshop: Preparing For The New EU Medical Device Regulations (MDR)

By: David R. Dills, Global Regulatory Affairs & Compliance Consultant and President, NovaQual.
Product code: SEM33
Location 1: Burlingame, CA Feb 21 - 22


Course has been Pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

"Each attendee will receive 2-Day workshop materials ,Certificate, Complimentary Breakfast , Lunch & High Tea/Coffee provided by WCS. "

The new Medical Device Regulations (MDR) were published in the Official Journal of the European Union on May 5, 2017. From that date, manufacturers, suppliers, Notified Bodies, and national competent authorities have a transition period of three years to comply with the new set of rules. Given the large scale of changes, there is great pressure on all actors to analyze the MDR, conduct impact assessments, and implement compliant processes. After May 2020, non-compliance threatens CE-mark certification, access to the European market, or, in the case of Notified Bodies, re-designation.
The European Union released the Medical Devices Regulation (MDR 2017/745/EU) to eventually replace the Medical Devices Directive and Active Implantable Medical Devices Directive. The MDR introduces numerous changes, including a shift from the pre-approval stage to more of a life-cycle approach. It also incorporates a variety of European guidance documents (MEDDEVs) into the regulation and emphasizes the importance of Post-Market Surveillance (PMS), clinical data, clinical evaluations, and Post-Market Clinical Follow-up (PMCF). MDR compliance presents many new challenges to medical device manufacturers. Our in-depth MDR training is designed to help you and your team prepare for these challenges and transition smoothly to the MDR.
This seminar provides a solid understanding of medical device regulation in the EU. It covers the history of medical device regulation in Europe and follows the regulatory requirements throughout the product lifecycle. You will gain a strong foundation of the key elements of the EU directives governing medical devices. These include: Active Implantable Medical Devices Directive (AIMDD) 90/385/EEC, Medical Devices Directive (MDD) 93/42/EEC and In Vitro Diagnostic Devices Directive (IVDD) 98/79/EC in their latest revision, including the 2007/47/EC amendments to AIMDD and MDD. This course examines how devices are classified, and the effect classification has on labeling, registration, marketing and postmarketing requirements. Learn about the new requirements in the Medical Device Regulation (MDR), including those related to quality systems, product classification rules, technical documentation, clinical evaluations, Unique Device Identification (UDI), and postmarket surveillance; and more importantly learn how to plan an efficient transition.

Here are some take away Note 

•         Join us on Educating US Medical Device Manufacturers on Effective Implementation Tactics & Strategies
•         The European Commission is ushering in a new era of medical device and in vitro diagnostic regulations - What do they mean for industry? Are you ready?
•         Expand your Networks of Support and Engagement with Industry Stakeholders and Colleagues
•         Comply with the Implementation Details and Requirements of the EU MDR & IVDR
•         Understanding the Transition Provisions, Re-Certification and Reclassification Components of MDR
•         Stay Informed. Be Proactive. Connect and Network with Seminar Attendees
•         Arrive with Questions about the New MDR and Learn more about FAQ’s from Experts and Industry
•         What do our Employees need to know about the MDR to Maintain Compliance?
•         How can we Prepare to Recertify to the MDR?
•         Many forward thinking medical device companies are already developing their plans for compliance now to gain strategic advantages over their competitors
•         Attendees will leave with a foundational understanding of the New MDR and we will share in detail what all the significant changes are and how you can begin preparing for compliance now
•         Would you like to understand what you need to do for the MDR? If the answer is yes, then this seminar is for you.  It has been designed from the ground up to give you the knowledge you need to get ahead of the competition. This isn't just a simple read and understand seminar, this is a 2-day day practical 'how to' guide, which you can actually use immediately. 

Areas Covered

•       Understand the Medical Device Regulations approach in Europe
•       Understand the structure and purpose of the Medical Device Directives
•       Explain the use of Essential requirements, including the use of (harmonized) Standards
•       Understand the key changes upcoming in the new EU MDR
•       Understand the essence of early start in the transition
•       Understand how to prepare a transition plan
•       Apply the Classification Criteria and Implementation rules
•       Identify the conformity assessment routes
•       Identify Technical Documentation requirements
•       Importance and Role of Clinical Data
•       Identify the importance and contents of Post Market Surveillance
•       Explain and differentiate between the scope of the three EU device directives
•       Outline how medical devices are classified using the European regulatory framework
•       Identify the important contents of each EU directive
•       Discuss the general requirements of preclinical and clinical testing in Europe
•       Describe the conformity assessment pathways for obtaining CE marking
•       Cite the key requirements for postmarketing surveillance
•       Explain the overall regulatory requirements for medical devices in the EU
•       Comply with the implementation details and requirements of the EU MDR & IVDR
•       Develop a “systems approach” for data usability/management
•       Label and mark your products
•       Internalize the core data elements
•       Distinguish the similarities and differences
•       Seminar attendees are encouraged to bring examples of their work from the functional area on the various topics as applicable for group discussion
•       Review and discuss pain points, challenges and solutions
•       Current and future trends

Who will Benefit

This seminar is designed for new regulatory professionals and others in related departments interested in understanding the basics of EU regulation of medical devices and the impact on medical device companies. Participants and attendees will be provided with a stimulating and practical working environment.

•        Senior Management
•        Regulatory Affairs Managers and Quality Managers
•        Design, Development, Manufacturing and Marketing Managers
•        Auditors
•        Compliance/Regulatory affairs professionals
•        QA/QC professionals
•        Manufacturing managers, supervisors
•        Project Managers
•        Compliance Officer
•        Compliance Specialist
•        Clinical Affairs
•        Marketing & Sales Management
•        Distributors/Authorized Representatives
•        Legal Counsel
•        Consultants

Learning Objectives

•        Class I, II and III/In Vitro Diagnostic medical device manufacturers
•        Contract medical device manufacturers
•        Contract sterilizers
•        Repackagers, relabelers, specification developers, reprocessors of single-use devices
•        Manufacturers of accessories and components sold directly to the end user
•        U.S. manufacturers of "export only" devices
•        Distributors
•        Importers
•        User Facilities (e.g., hospitals, nursing homes)

Course Outline:

Day 1 Schedule

•        Introductions and Background
•        The objectives of the MDR
•        Scope & Definitions
•        Placing CE marked product on the market
•        EUDAMED and significance of the European Electronic Database
•        Notified Bodies
•        Classification and Conformity Assessment
•        Clinical Evaluation & Investigations
•        PMS and Vigilance
•        Quality management system requirements in the MDR
•        Device classification and conformity assessment routes changes in the MDR
•        Technical documentation requirements
•        Clinical evaluation process requirements
•        UDI and traceability requirements
•        Postmarket surveillance and reporting requirements
•        Life-cycle review of products linked to risk management and clinical evidence
•        Implications for Notified Bodies, and for organizations working with Notified Bodies
•        Impact on product portfolios and classification
•        The need for improved clinical evidence
•        Strengthening of post market surveillance (PMS)


Day 2 Schedule

•        How can we prepare to recertify to the MDR?
•        Is there an efficient, cost-effective way to train our team on the MDR?
•        General obligations of the medical device manufacturer
•        Uploading data and maintaining compliance with EUDAMED
•        UDI in Europe and how it compares with US FDA UDI requirements and traceability of the supply chain
•        Classifying medical devices under the European MDR
•        Conformity assessment procedures and the role of Notified Bodies
•        Safety and performance requirements
•        Navigating standards under 2017/745/EU
•        Clinical evaluations and “new rules” on adequacy of clinical data and clinical investigations
•        Clinical investigations and Clinical Research Organizations
•        Post-Market Surveillance (PMS) and Post-Market Clinical Follow-up (PMCF)



David R. DillsGlobal Regulatory Affairs & Compliance Consultant and President, NovaQual

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. He has been previously employed, with increasing responsibilities by medical device manufacturers and consultancies, including a globally recognized CRO and has worked directly with manufacturers engaged in compliance remediation activities and services involving consent decrees, CIA’s, warning letters, 483 observations, and customer generated compliance events, and prepares for and conducts regulatory and compliance assessments. He leads and directs all activities for the product registration and approval process and working with the regulatory agencies in Asia Pacific (APAC), EU, Latin America (LATAM), Middle East, EMEA, including but not limited to FDA, European Medicines Agency, MHRH, ANVISA, MOH, PMDA, MOH, TFDA, MDCO, CFDA, TGA, Health Canada and others regarding multi-country product registrations and licensing. Mr. Dills manages quality, regulatory and compliance projects with multiple competing priorities having a direct impact on site operations/commercial opportunities while developing strategies for governmental approval to introduce new products to market. He conducts communications with regulatory authorities and company representatives while executing an effective path to approval and helping with GxP compliance strategies in global markets. 

21-February-2018 To 22-February-2018 Burlingame, CA
Seminar One Registration
$ 1395

Special Group Discount Register for Four attendees
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Hilton Garden Inn San Francisco Airport / Burlingame
765 Airport Blvd.
Burlingame, CA 94010
Phone: (650) 347.7800

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I have attended various seminars from WCS but this "Live" one was incredible. This seminar was excellent.

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I liked WCS training style. WCS speakers gave excellent examples to back up what speaker was explaining. Which helped me grasp a better understanding."

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The presenter was excellent session leader, very knowledgeable and well-spoken. The topic was well chosen and interaction between the participants and the presenter was good.

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This was an informative seminar. Provided very valuable insight into how the FDA works. Presenters' experience in real life events and interaction with the FDA is priceless.

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