OMTEC 2015 Speaker Presentations

2016 European Medical Device Regulations: Significant Changes for Importers and Distributors

The European Commission and Notified Bodies are preparing to implement new, tougher European Medical Device Regulations (EMDR) in 2016. Among the changes are new requirements for the roles and responsibilities of “economic operators” (e.g., manufacturers, importers and distributors). The EMDR requires each company in the supply chain to verify that the previous economic operator in the supply chain complies with the EMDR. This presentation is designed to help you update your policies, procedures, training and supplier agreements for compliance with the 2016 EMDR.

Session Takeaways:
  • Brief Overview of the 2016 EMDR
  • New roles and responsibilities for distributors, importers and manufacturers
  • Recommended changes to your supplier agreements
Who Should Attend?
  • Product Management
  • Supply Chain Management
  • Regulatory and Clinical Affairs

Rob Packard is a regulatory consultant with 20+ years of experience in the medical device, pharmaceutical and biotechnology industries. He is a graduate of UConn in Chemical Engineering. Mr. Packard was a senior manager at several medical device companies, including CEO of a laparoscopic imaging company. His Quality Management System expertise covers all aspects of developing, training, implementing and maintaining ISO 13485 and ISO 14971 certification. From 2009-2012, he was a Lead Auditor and instructor for BSI. Mr. Packard’s specialty is regulatory submissions of high-risk medical devices for CE marking, Canadian medical device applications and 510(k) submissions. He founded Medical Device Academy in 2012 as a consulting firm focused on helping medical device companies with regulatory submissions and ISO 13485 certification. The most favorite part of his job is training others.