Medical Device Postmarketing Vigilance Reporting: New Update, Guidance, and Expectations for Manufacturers

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Course Description

Major postmarketing vigilance revisions are now in force. A revised medical device guidance document on postmarketing vigilance (MEDDEV 2.12-1 rev 5) came into force on January 1, 2008. Providing more guidance than the previous version, the new document includes new reporting terminology and concepts such as “periodic summary reporting” and “trend reporting.” In addition, the terms “advisory notice,” “near incident,” and “recall” have been eliminated or replaced. Although MEDDEVs are not legally binding, it is likely that all European Competent Authorities will follow the new guidelines and will expect organizations involved in the management and reporting of adverse incidents to follow them as well. Seminar topics include new terms and definitions, the guideline’s extended scope, reporting criteria and timelines, filing safety notices and field safety corrective actions, the vigilance aspects of revising Directive 2007/47/EC, and more.

As an added bonus, for those device manufacturers seeking the CE Mark, you will learn the expectations and requirements and understand the “road” to CE Marking of your devices. For most products sold in the EU, the use of CE Marking and a Declaration of Conformity are mandatory. 

Learning Objectives

  • Examine the latest changes, new terminology, and new concepts to MEDDEV and Medical Device Vigilance and impact on medical device manufacturers
  • Consider how to implement the suggested or recommended changes for  postmarket vigilance guidelines as of January 1, 2008
  • Report incidents as recommended by the guidance
  • Examine why Global Harmonization Task Force (GHTF) is an integral component of the new postmarketing vigilance guidelines
  • Manage expectations for reporting and timelines
  • Recognize which amendments impact the European vigilance system
    Interpret the new guidelines that cover incidents involving devices that carry the CE mark and devices that do not carry the CE mark
  • Submit periodic summary reports of incidents to Competent Authorities
  • Examine controversial aspects of the guidelines
  • Identify the conditions under which reporting is not required
  • Identify the CE Marking directive(s) and conformity assessment procedures that are applicable to your product
  • Ensure that your device fulfils the essential CE Marking requirements and prepare technical documentation
  • Prepare the Declaration of Conformity and make documentation available to Competent Authorities (EU Members)
  • Affix CE marking on your product and/or its packaging and accompanying literature as stated in the directive… and now sell your device in the EU
Who Should Attend

  • Regulatory Affairs
  • Compliance
  • QA
  • Management Representatives
  • Marketing & Sales
  • Consultants
  • Distributors and Representatives
  • Operations

The course will be led by one of the following instructors:

David R. Dills

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Course Outline

Day 1: 8:30 a.m. – 5:00 p.m.

  • Introduction to the New Guidance: Directive 2007/47/EC; MEDDEV documents; harmonization initiatives of the Global Harmonization Task Force (GHTF)
  • New Terminology, Replaced Terminology, New Concepts: Periodic summary reporting; trend reporting; advisory notice; near incident; recall
  • Impact of Guidance on Medical Device Manufacturers: timeline of incorporation of new changes; complying with amended requirements; expectations of Competent Authorities
  • Materials Requiring Revision: quality manual, SOPs for complaint handling; incident reporting; recall; field corrective action; advisory notices; clinical investigation; authorized representative and distributor agreements
  • Reports Impacted by the MEDDEVs: Periodic trend reporting; summary reporting; adverse event reporting; other reports; new reporting timelines
  • The Road to CE Marking: Relevant directives; conformity assessment procedure; meeting essential requirements; maintaining technical documentation; Declaration of Conformity

Interactive Activities

  • Group Discussions and Substantive Review of the Guidance and Manufacturers’ Next Step for Deploying and/or Revising Policies and Procedures
  • Review and discussion of sample reports impacted by the MEDDEVs

Registration Fees

Registration fees include assorted breakfast items that will be available each day ½ hour prior to the start of the seminar. Also included is a Networking Lunch that will be served each training day.

Special rates are available for multiple attendees from the same organization.  Contact Elizabeth Andrews at 781-972-5418 to discuss your options and take advantage of the savings.

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Accreditation Information

ACPE LogoBarnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Participants will receive 7 hours (0.7 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test and program evaluation.  Barnett International will mail ACPE statements within three weeks of program completion.  ACPE# 0778-0000-12-002-L01-P. Released: 4/12.

Hold this course at your company!

For more information, contact Naila Ganatra at (215) 413-2471.