Proposed Changes in the European Medical Device Directive 2012\0266 (COD): A Practical Approach to the New Regulations

Why Should You Attend:

The M5 version of the MDD (i.e. – the 2007/47/EC amendment to 93/42/EEC), implemented on March 21st of 2010, resulted in minor and major nonconformities throughout the medical device industry during annual Notified Body audits. The 2007/47/EC amendment reclassified some high-risk devices from to Class III devices and the amendment made Clinical Evaluations mandatory for all products (i.e. – Essential Requirement 6a). For some companies, it took more two years to achieve compliance. These were minor changes when compared to the 2012/0266 proposed regulation. These proposed regulations are approximately twice as long as both of the previous directives (MDD & AIMD) combined.

Learning about these changes and understanding how the changes will affect your company will allow companies to revise and update their policies and procedures prior to the implementation period. A better understanding of the changes will avoid unnecessary nonconformities and delays to new product introductions in Europe.

This course has been designed to help you understand and recognize the most significant changes proposed for the new European Medical Device Regulations: 2012/0266 (COD). You will learn which procedural changes your company should be making now so that you stay in compliance throughout the transition period and reduce potential delays to new product introductions in the EU market.

Areas Covered in this Session:

This webinar will provide valuable assistance to all medical device companies in evaluating their anticipated CE Marking applications and any supplemental changes. The focus will be on practical approaches for addressing the proposed changes in the Medical Device Regulations for Europe—released September 26, 2012. Critical changes with significant impact include:

1. device classifications.
2. clinical investigation requirements.
3. clinical evaluation requirements.
4. UDI implementation and implant cards.
5. role of economic operators.
6. Notified Body (NB) selection.
7. Medical Device Coordination Group (MDCG).
8. vigilance & post-market surveillance requirements.
9. post-market clinical follow-up studies.
10. sources of post-market data.

Who Will Benefit:

This topic applies to personnel / companies in the medical device industry. The employees who will benefit most include:

• Senior management
• Regulatory affairs
• Quality Assurance
• Engineering / R&D
• New product development teams
• Marketing and Sales
• Product Packaging and labeling
• Suppliers to medical device companies

Instructor Profile:

Robert Packard, is a regulatory consultant with 20 years experience in the medical device, pharmaceutical and biotechnology industries. Robert has worked with companies from start-ups to Fortune 100, in the USA, Canada, Mexico and Japan. His specialty is helping companies with regulatory submissions for high-risk medical devices and drug/device combination products. His regulatory expertise includes: CE Marking, Canadian Medical Device Applications, 510(k) Submissions, Post-Marketing Activities, Supplier Quality, CAPA, Risk Management, Auditing and Sterilization Validation. He has held previous positions in R&D, Manufacturing Operations, Quality Assurance and Regulatory Affairs—up to the level of CEO/President. In addition, Robert has extensive technical experience in Lean Manufacturing, Silicone Chemistry, Extrusion, Bioprocess Engineering, and Strategic Planning. He was a 3rd party auditor for one of the largest Notified Bodies, and he conducts training workshops internationally on a variety of regulatory subjects. Robert is a graduate of UConn in Chemical Engineering.

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