Leo Eisner will be presenting on the topic “RoHS2 and Its Impact on the Medical Device Industry” at an FX Conferences event on 17 Dec, 2013 (Tues) at 11:00AM – Noon (Pacific), 2:00PM – 3:00PM (Eastern). You don’t have to leave your office to join in on the presentation and as a special thank you for visiting us at Eisner Safety Consultants you can get a $50.00 discount.
What’s it about: Are you ready for implementation of the EU RoHS2 Directive 2011/65/EU (Restriction of Hazardous Substances – recast)? If not, you may need to stop shipment of your medical devices to the EU. The RoHS2 Directive has been implemented and the transition period has officially passed. The medical device industry is one of several industries with a small reprieve, but that time frame is running out quickly and there is less than a year to prepare. In July of 2014 you will need to ensure that your medical electrical & electronic equipment (EEE) devices meet the RoHS2 Directive.
This Directive doesn’t just impact the manufacturer but also the importers and distributors as well. Join us to find out more about the impact on the medical device industry, as our speaker guides attendees through the key parts of this Directive, including the scope, definitions, timelines, exemptions, roles & responsibilities for manufacturers, importers & distributors, technical documentation requirements, assessment of conformity with the Directive, record retention, Authorized Representative requirements, and much more.
This audio conference will cover:
- EU RoHS2: scope, definitions and exemptions for the medical device industry
- Compliance requirements for manufacturers, importers and distributors
- Requirements for technical documentation, Declaration of Conformance, record retention, marking, affixing the CE Mark, and Authorized Representative
- Conformity Assessment of the product with the Directive
- Market surveillance for RoHS2 Directive
- Recalled products requirements and corrective action to be taken
- Notification to national authorities and supply chain of non-compliant product
- COCIR requested product exemptions
- Resources and tools to help along the way
To find out more about the presentation & discount ($50.00 off regular price) click here for the details and also some other past presentations that Eisner Safety Consultants have presented for FX Conferences previously.