EU Medical Device Regulation (MDR) - Updated CE Marking Process & ISO 13485:2016 Expectations

EU Medical Device Regulation (MDR) - Updated CE Marking Process & ISO 13485:2016 Expectations

The EU Medical Device Regulation (MDR) recently brought about major changes into its regulatory requirements for medical devices. These changes will have a major impact on the way medical devices are going to be registered and marketed in the huge EU market.

Understanding these regulations is very important and necessary for medical device manufacturers that eye the lucrative market that the EU consists of. Lack of knowledge of these updated regulations can have a negative impact on a medical device manufacturer that wants to market its products in the EU.

A highly valuable and relevant webinar that Compliance4All, a leading provider of professional training for all the areas of regulatory compliance, is organizing on February 21, will offer core insights into this new regulation, which will help manufacturers understand the nuances of this new amendment and have a smooth passage for their products into the EU market.

Offering this very vital learning is Robert J. Russell, President/CEO, RJR Consulting, Inc. Please visit Compliance4all to register for this webinar.

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At this webinar, Robert will offer very sharp insights into the EU MDR, which he has gained from having been directly involved and in working within the EU. It is also gleaned from the EU Commission's major improvement objectives to their system.

The major areas of discussion he will bring at this session are the changes that have taken place between the MDR’s predecessor, the Medical Device Directive (MDD) and the MDR. He will also explain the MDR’s regulatory expectations when it comes to implementing the ISO-13485:2016.

He will simplify the grasp of the requirements that go into this regulation. He will describe how medical device companies that market their products in the EU are viewing and implementing these changes. This course will offer the participants a better ken of the ever-changing landscape of Medical Device Regulation in the EU

The speaker will cover the following areas:

• EU Regulatory and Legislative Structure
• EU Definition of a Medical Device
• 3 EU Directives -> 2 EU Regulations
• Key Agencies Involved
• Why the change from Directives to Regulations?
• Overview of CE Marking Process & Changes Resulting from the EU MDR
• Updated Role of the Notified Body
• Medical Device Classifications
• Essential Requirements -> Safety & Performance Requirements
• Integration of Risk Assessment/Risk Management
• Conformity assessment
• Device Vigilance & Reporting System
• MDR Overview (by Article & Annex)
• ISO 13485:2016 Updates
• Medical Device Single Audit Program (MDSAP)
• Global Impact of ISO 13485:2016 Certification and CE Marking
• Tips on Working with Regulatory Authorities.

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About the expert: Robert J. Russell is President of RJR Consulting, Inc. The company assists the pharmaceutical, medical device and biotech industries in understanding and complying with International Regulations affecting compliance, new product development, manufacturing and quality assurance. RJR has offices in Columbus, OH, Washington DC, and Brussels, Belgium with exclusive affiliates across Asia and Latin America.

Bob has 28 years of past industry experience as a CMC specialist, R&D Director and Global Director of Regulatory Affairs for Merion Merrill Dow pharmaceuticals and Cordis-Dow medical devices. He has a BS/MS degree in Chemistry.

Compliance4All is a professional trainings provider for the regulated industries. It offers professional trainings for regulatory compliance professionals and offers innovative strategic consulting and advice to a broad range of organizations.