OMTEC 2015 Speaker Presentations

2016 European Medical Device Regulations: Preparing for the Spinal Implant Reclassification

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In 2007, the risk classification for hip, knee and shoulder implants was changed from Class IIb to Class III. Now the European Commission and Notified Bodies are preparing to implement new, tougher European Medical Device Regulations (EMDR). The EMDR includes risk reclassification of spinal implants from Class IIb to Class III. Based upon lessons learned from the previous reclassification, you can expect long lead times at all of the Notified Bodies, and the backlog is expected to last for all of 2017 and 2018. This presentation provides practical advice for converting your Technical Files for each spinal implant into Design Dossiers for submission in 2016.

Session Takeaways
  • Differences between a Technical File (TF) & a Design Dossier (DD)
  • Which parts of your existing Class IIb TF need to be stronger
  • How to write Summary Technical Documents (STEDs)
  • FREE Template for TF/DD Index that doubles as a DMR Index for FDA
  • FREE Template for 2016 EMDR, Annex III Declaration of Conformity
  • FREE Template for 2016 EMDR, Annex I Essential Requirements Checklist
  • Recent Trends in Notified Body Nonconformities for Technical Audits
  • Selection of “Special Notified Bodies” (SNBs)
Who Should Attend?
  • Research & Development
  • Regulatory and Clinical Affairs

Speaker Bios


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.

Additional Reads from BONEZONE®:
Start Early: Converting Your Spinal Technical File into a Class III Design Dossier
Sterilization: How to Validate Novel and Non-Traditional Processes
The Anatomy of a Successful Design Plan

Prepare for this Session

Converting Your Spinal Technical File into a Class III Design Dossier

  1. The EU Commission is in the process of converting the Medical Device Directive into the European Medical Device Regulations (EMDR). As part of this change, spinal implants will be reclassified from Class IIb to Class III devices. Also, the EMDR will involve more stringent controls over Notified Bodies (NBs) that issue CE certificates.
  2. Companies that currently have a Class IIb Technical File ask me, “What’s the difference between a TF and a DD?” In theory, there should be little difference between the two types of technical documentation. However, the adjustment is quite traumatic for a company that has never prepared a DD. OEMs need to be prepared for three primary differences.The auditor will request a summary of all the design changes that have occurred since the device was first launched
  3. The auditor will spend at least twice as much time reviewing the new DD as was spent on the TF for the same product, and
  4. Every future design change needs to be pre-approved by the Special Notified Body instead of having the TF sampled once every three years.

The impact of these three differences appears to be subtle, until you do the work.