Medical Device CE Mark & Quality System Certification: Recent & Proposed Changes

Why Should You Attend:

Medical devices sold into the European Union (EU) must comply with the applicable medical device directives, EU laws similar to FDA’s regulations.

Medical devices declared compliant must bear a CE mark in order to be admitted into the 29 member countries comprising the EU. The market population of these 29 countries is 450 million people, exceeding the 420 million people served by NAFTA (USA, Canada & Mexico), so many companies have an interest in penetrating this market. This presentation will provide an explanation in layman’s terms of the various routes to CE marking of medical devices, with a focus on the Medical Device Directive, MDD 93/42/EEC.

Areas Covered in the Webinar:

• New approach directives & background
• IVD, MDD & Active Implantable Directive
• Impact of significant recent & proposed changes
• Competent Authorities & Notified Bodies
• Medical Device Directive vs. Regulation vs. ISO 13485
• Device classification
• Routes to CE marking under various MDD annexes
• Technical files vs. Guidance Documents
• Essential requirements
• Significant Changes Coming

Who Will Benefit:

Companies wishing to penetrate the EU market for medical devices or sharpen their skills will receive practical guidance on achieving the CE mark. Employees who will benefit include:

• Quality & Regulatory Professionals
• Manufacturing & Design Engineers
• Marketing Product Managers
• Program Managers

John Chapman
Principal at Chapman Consulting LLC

John Chapman, BS, MBA, RAC has over 35 years medical device regulatory experience and over 15 years experience with the European Union’s medical device directive, 93/42/EEC. John has led two device companies to ISO quality system certification and CE marking. He has performed regulatory due diligence on over a dozen acquisitions in the past 12 years, exposing him to numerous quality systems, including consent decrees as well as many notified bodies. RAB Accredited Lead Auditor Course Certificate1996. He earned his regulatory affairs certification (RAC) in 1998 and was a contributing author to 2004 Fundamentals of EU Regulatory Affairs, RAPS, 2004. He co-founded a local RAPS chapter and has been a speaker at these meetings and the annual RAPS conference.

John has had specialized training and experience in FDA QSR, ISO 13485, European Medical Device Directives, ISO 9001, Canadian Medical Device Regulations, Auditing, Root Cause Analysis, Design Control, Bloodborne Pathogens, Hazardous Waste Handling, and FDA regulations. He has also presented live on-line seminars on various regulatory and quality system subjects.

Topic Background:

CE marking of all medical devices is required before shipment into most of the European countries. Technical documentation requirement for obtaining the CE mark is similar for shipment into Canada and is rapidly expanding to other countries.

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