Clinical Evaluation and the Latest 2016 Guideline

1. Clinical Evaluation and the Latest 2016 Guideline www.grcts.com

2. Clinical Evaluation and the Latest 2016 Guideline Description: This “General Guidance” document promotes a common approach to clinical evaluation for "medical devices regulated by directives 90/385/EEC and 93/42/EEC. It does not concern in vitro diagnostic devices. The depth and extent of clinical evaluations should be flexible and appropriate to the nature, intended purpose, and risks of the device in question. Therefore, this guidance is not intended to impose device-specific requirements. The Clinical Evaluation Report (CER) is a living document required for the EU market for all classes of new and existing devices, detailing the clinical evaluation of a product throughout its life-cycle. www.grcts.com

3. Clinical Evaluation and the Latest 2016 Guideline While the requirement to have a CER is not new, it is subject to more intense scrutiny by Notified Bodies in the conformity assessment phase, and CERs are increasingly being assessed in the post-market phase. This revised MEDDEV is being generated within a context of increased scrutiny on the Notified Bodies. The revision of this document represents a complete re-write of this MEDDEV, with many new Appendices and much new guidance. The new MEDDEV can be considered more instructive, but also more prescriptive in particular regarding the use of evidence from equivalent devices. www.grcts.com

4. Clinical Evaluation and the Latest 2016 Guideline Areas covered in the session: • Introduction to MEDDEV 2.7.1, Revision 4 (2016) • This revised MEDDEV is generated within a context of increased scrutiny on the Notified Bodies (NB) by the Joint Assessments from the Competent Authorities, which has led to an increase in the level of review the NB exercise over clinical evaluation • Frequency for updating the CER is also much more prescriptive now and you must define and justify the frequency, based on “significant risk” of the device, as well as how “well-established” • One of the largest changes in this revision, the demonstration of “equivalence” is much harder now www.grcts.com

5. Clinical Evaluation and the Latest 2016 Guideline  Revision will lead to more clinical investigations, probably of larger size and notified bodies will be looking more closely at how all the essential requirements are met, including those with regard to usability•    Manufacturers should start discussing with their notified bodies how they will start implementing these new requirements and to start performing their gap assessments and resource needs-assessments now. •    General considerations on updating the clinical evaluation•    How is a clinical evaluation performed?•    Appraisal of pertinent data•    The role of the notified body in the assessment of clinical evaluation reports and key changes in 2016•    Other changes and revisions of this document and represents a complete re-write of this MEDDEV, with many new Appendices and much new guidance www.grcts.com

6. Clinical Evaluation and the Latest 2016 Guideline Who will benefit: This webinar will provide valuable and additional insight and an overview for the medical device and IVD companies involved in establishing and maintaining a state of compliance and meeting compliance deadlines for UDI. Employees and personnel who will benefit include: • All levels of management and departmental representatives any anyone who desire a better understanding or a "refresh" overview of MEDDEV 2.7.1, Revision 4 www.grcts.com

7. Clinical Evaluation and the Latest 2016 Guideline •  CRO’s •    Regulatory Affairs•    RA Specialists•    Clinical Affairs•    Project Leaders for MEDDEV Compliance •    Quality Control/Quality Assurance•    Compliance•    Marketing & Sales •    Distributors/Authorized Representatives•    Engineering/Technical Services•    Consultants•    Manufacturing •    Auditors www.grcts.com

8. Clinical Evaluation and the Latest 2016 Guideline Instructor Profile: David R. Dills, Global Regulatory Affairs & Compliance Consultant currently provides regulatory affairs, compliance and quality consultative services for early-stage and established Class I/II/III device, In Vitro Diagnostics, cosmetics and bio/pharmaceutical manufacturers on the global landscape, and also has an accomplished record with more than 25 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 QS and regulatory audits.   www.grcts.com

9. Clinical Evaluation and the Latest 2016 Guideline He has been directly involved with constructing, reviewing, and/ or remediating regulatory submissions, including 510(k), PMA, IDE applications, IND, BLA and NDA submissions, preparing Supplements, Amendments, U.S. Agent, works closely with the key stakeholders  and Agency/Center Reviewers regarding submission meetings and negotiations; clinical affairs and study submissions; and provides regulatory submissions and post-market project leadership and guidance covering different therapeutic and medical specialties based on classification.   www.grcts.com

10. Clinical Evaluation and the Latest 2016 Guideline Mr. Dills has a strong background in the interpretation and applicability of FDA regulations, including 21 CFR 210/211, 820 QSR/cGMP, Quality System implementation and compliance requirements, GxP training, leads and directs activities for the registration and approval process and working with Agencies in Asia Pacific, EU and The Americas, including but not limited to FDA, European Medicines Agency–EMA, MHRH, ANVISA, PMDA, MOH, SFDA, TGA, and Health Canada; and defining and executing regulatory compliance, risk mitigation and remediation strategies in response to inspection findings. Additional activities include Pre-FDA Facility Inspections, Mock Audits/Due diligence and assessing state of readiness for Pre-approval inspection (PAI/PMA), proof of management oversight, facilitate and direct efforts for remediation planning and monitoring, and assessment of the critical sub-systems, records and document controls; and strives for reduction of regulatory compliance risk for companies. www.grcts.com

11. Clinical Evaluation and the Latest 2016 Guideline Directs and leads efforts for PM support and consultative services on behalf of manufacturers and subcontracted by third-party consultancies and provides services involving all phases of the product development, submission, and commercialization process from premarketing to postmarketing; retained as U.S. Agent for international pharma and device clients; conducting supplier and QS audits/assessments; establishment registration and listing; Agency inspection readiness preparation and remediation; preparing Agency responses due to enforcement actions; conducting GxP audits and preparing CAP/remediation plans; compliance engineering support; support and/or lead efforts regarding Adverse Event, MDR, Incident Reporting, Postmarketing Surveillance and Vigilance Reporting; clinical affairs, establish and/or remediate Quality Management and documentation systems for GxP compliance; preparation for ISO 13485 registration and CE Mark; and multi-country product registrations and licensing.     www.grcts.com

12. Clinical Evaluation and the Latest 2016 Guideline Mr. Dills manages quality, regulatory and compliance projects with multiple competing priorities having a direct impact on site operations/commercial opportunities. Develops strategies for governmental approval to introduce new products to market, provides guidance and clarity on regulatory requirements, prepares and/or reviews submissions [e.g., NDA, ANDA, 510(k), PMA, IDE and BLA], including design dossiers and technical files, and other applications for Asia Pacific, The Americas and EU. Directs and leads efforts in establishing and retooling QA systems with emphasis on preventing the design, manufacture, and shipment of defective product; provide compliance engineering support; and lead efforts for GxP Strategic Compliance. www.grcts.com

13. Clinical Evaluation and the Latest 2016 Guideline Mr. Dills manages regulatory problems (e.g. AE’s, MDRs, Agency enforcement, and complaints) related to development, manufacturing, and commercialization, and recommends action to senior leadership to ensure effective resolution for manufacturers to achieve sustainable and proven compliant systems. Background encompasses broad capabilities in quality systems; documentation development and remediation; RA/RC oversight and governance; design controls; CAPA/investigations; GxP training; software and process validation with compliance oversight; supplier management; interfaces with FDA and other Agencies on the regulatory landscape; compliance with MDD/IVDD Directives and Technical File/Design Dossier and CE Mark requirements; and demonstrates credible experience to optimize business performance through proactive strategies to mitigate compliance exposure.   www.grcts.com

14. Clinical Evaluation and the Latest 2016 Guideline He also develops strategies and adds business value to manufacturers by providing strategic and tactical solutions that facilitate the achievement of regulatory and quality milestones and on minimizing delays due to noncompliance. He conducts Compliance Governance Assessments and Agency Mock Inspections; provides assistance during inspections and with post-inspection correspondence and meetings, involved in the product life cycle and commercialization process and works effectively across all functions for overall corporate compliance to support a company’s goals and strategies. Mr. Dills analyzes the benefits/risks for informed decision-making; interprets the regulatory precedents and new legislation; understands the competitive landscape; develops the business and regulatory approach; conducts persuasive communication with regulatory authorities; executes an effective path to approval; assists with GxP compliance strategies, effectively coordinates development in multiple markets; selects appropriate testing and manufacturing suppliers; and strives for overall corporate compliance with regulations in The Americas, EU, and Asia Pacific. www.grcts.com

15. Clinical Evaluation and the Latest 2016 Guideline He provides direction on understanding the regulatory landscape for the product and provides a fully integrated approach to device development including design controls, and effective communications with Regulatory Authorities related to product development and post-marketing activities. Mr. Dills has served on the Faculty Advisory Board for the Pharmaceutical Training Institute, Editorial Advisory Boards for Software Quality Professional and the Institute of Validation Technology (IVT), publisher of the Journal of GXP Compliance and Journal of Validation Technology and on the Readers’ Board for Medical Device & Diagnostic Industry and Medical Product Manufacturing News and was nominated and accepted for inclusion into the 2005-2006 Strathmore’s Who’s Who of Professionals. www.grcts.com

16. Clinical Evaluation and the Latest 2016 Guideline Mr. Dills has authored and published validation, regulatory and compliance-related articles, commentaries and technical guides, and is an accomplished global industry presenter. Mr. Dills’ academic degrees include Environmental Science and Biology. He is a former Chair and Co- Chair of ASQ’s Section 1506 and associated with the Biomedical Division, RAPS, AdvaMed, PDA, ISPE, and other industry working groups. www.grcts.com