EU's MDD Mod 5 Changes due March 2010 - Impact on CE-mark Compliance

Instructor: John E Lincoln
Product ID: 701596
Training Level: Intermediate
  • Duration: 75 Min

recorded version

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Read Frequently Asked Questions

This EU Medical Device Directive (MDD) training will guide you through changes to the Medical Device Directive 93/42/EEC, by the M5 Directive 2007/47/EC and its effect on CE mark and steps to comply.

Why Should You Attend:
The EU Medical Device Directive (MDD) classifications are based on Annexes to the MDD and are determined by the manufacturer and notified body, and explained in the product's Technical File or Design Dossier. The MDD classification system is somewhat different from the classification of medical devices in the U.S., which are defined by information in the Code of Federal Regulation, by law, and are not left up to the manufacturer.

The European Union has mandated changes to the Medical Device Directive 93/42/EEC, by the M5 Directive 2007/47/EC. The Mod 5 changes to the MDD become operative in March 2010, requiring the product's Essential Requirements to be reevaluated, updated, which may include additional testing, and the Technical File or Design Dossier updated accordingly. Any such changes must be audited by the company's notified body, prior to the affixing of the CE-mark and sale in Europe.

Attend this Webinar to understand What are the key changes required for CE-marked product? Why are they modified? How should they be implemented? What documents are affected? And the steps to comply with it.

Areas Covered in the Seminar:

  • Relevent sections of the basic MDD.
  • Steps to comply.
  • Testing Requirements.
  • Clinical Issues.
  • Documentation.
  • Audit.

Who Will Benefit:

This webinar will assist all those to be involved in the global regulated medical device industry.This includes:
  • Senior management
  • Regulatory Affairs
  • Quality Assurance
  • Production
  • Engineering
  • Sales and Marketing
  • All personnel involved in the development, use, documentation, and review of documentation to support CE-marking and global sales

Instructor Profile:
John E. Lincoln, is Principal of J. E. Lincoln and Associates, a consulting company with over 28 years experience in U.S. FDA-regulated industries. John has worked with companies from start-up o Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, new / changed product 510(k)s, process / product / equipment including QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files. He's held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D).

In addition, John has prior experience in military, government, electronics, and aerospace. He has published numerous articles in peer reviewed journals, conducted workshops and webinars worldwide on CAPA, 510(k)s, risk analysis / management, FDA / GMP audits, validation, root cause analysis, and others. John is a graduate of UCLA.

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