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This EU MDD webinar will 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.

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.

Areas Covered in this Session:

- device classifications.
- clinical investigation requirements.
- clinical evaluation requirements.
-UDI implementation and implant cards.
- role of economic operators.
- Notified Body (NB) selection.
- Medical Device Coordination Group (MDCG).
- vigilance & post-market surveillance requirements.
- post-market clinical follow-up studies.
- sources of post-market data.

Who Will Benefit:

- Senior management
- Regulatory affairs
- Quality Assurance
- Engineering / R&D
- New product development teams

Official Website:

Added by complianceonlinecom on November 7, 2012