Clinical Evaluation and The Latest 2016 Guideline

Clinical Evaluation and the Latest 2016 Guideline
www.grcts.com
11/18/2016

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.
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11/18/2016

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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
11/18/2016

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

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11/18/2016

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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
11/18/2016

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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
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11/18/2016

CROs
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
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11/18/2016

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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, CIAs, warning letters, 483 observations, and customer
generated compliance events, and prepares for and conducts QS and regulatory audits.
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11/18/2016

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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.
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11/18/2016

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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 AgencyEMA, 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 Preapproval 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.
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11/18/2016

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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.
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11/18/2016

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Mr. Dills manages quality, regulatory and compliance projects with

multiple
competing
priorities
operations/commercial
having
opportunities.
direct
Develops
impact
on
site
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.
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11/18/2016

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Mr. Dills manages regulatory problems (e.g. AEs, 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.
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11/18/2016

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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 companys
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.
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11/18/2016

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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 Strathmores Whos Who of
Professionals.
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11/18/2016

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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 ASQs Section 1506 and associated with the
Biomedical Division, RAPS, AdvaMed, PDA, ISPE, and other industry working
groups.
www.grcts.com
11/18/2016

Clinical Evaluation and The Latest 2016 Guideline

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