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Start Early: Converting Your Spinal Technical File into a Class III Design Dossier

CE Marking of orthopaedic devices requires creating and maintaining technical documentation. This documentation demonstrates that the devices meet the safety and performance requirements specified in the Medical Device Directive (MDD). For a Class IIb orthopaedic device, we call this documentation a Technical File (TF). In the case of Class III devices, we use the term Design Dossier (DD).

In 2005, the EU Commission reclassified joint resurfacing implants for the hip, knee and shoulder from Class IIb to Class III. European regulators noticed an increasing trend of these implants wearing out and more patients were requiring revision surgery. 

Therefore, orthopaedic device manufacturers were given two years to transition 100 percent of these implants to a Class III Design Examination Certificate. This was followed by additional changes in the M5 version of the MDD, with an implementation deadline of March 21, 2010.

Now the EU Commission is in the process of converting the MDD into the European Medical Device Regulations (EMDR). As part of this change, spinal implants will be reclassified from Class IIb devices (as per Rule 8 of the MDD) to Class III devices (as per Rule 8, indent 8 of the proposed EMDR). Also, the EMDR will involve more stringent controls over Notified Bodies (NBs) that issue CE certificates. The proposed EMDR requires all NBs to reapply for the role of NB, and NBs that want to continue to issue CE certificates for Class III devices will be required to apply for the role of “Special Notified Body” (SNB). The timing of the EMDR is still unknown, but the best guess is that these changes will be implemented in late 2014 or early 2015.

What’s the Difference?
Companies that currently have a Class IIb TF 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. There are three primary differences for which OEMs need to be prepared:

  1. The auditor will request a summary of all the design changes that have occurred since the device was first launched
  2. 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
  3. Every future design change needs to be pre-approved by the SNB 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.

A Summary of Design Changes
When you submit a new DD for approval the first time, there are typically few changes, if any, to the design since the design validation was completed. However, when an existing product is reclassified from Class IIb to Class III, the OEM must summarize each change that occurred to the product since its launch. Even if a clinical study was performed on the original product family, it is unlikely that each additional change was validated with a clinical study. Benchtop testing and cadaver labs are often used to verify and validate these design changes, but postmarket clinical follow-up (PMCF) studies may be needed to evaluate the residual risks of the device for the post-launch design changes.

Which Parts of your Existing TF Need to be Stronger?
When I perform a gap analysis of a new client’s technical documentation, I find four areas that are frequently weaker than what is required for a DD submission. These four areas are:

  1. Risk Management File
  2. PMS Plan
  3. Clinical Evaluation Report
  4. Design Validation

In the area of risk management, technical documentation should include a summary technical document (STED) that summarizes the risk management activities and references each of the risk management documents in the risk management file. Unfortunately, what I find is a copy of the risk management procedure and a design FMEA. I also see few companies that have made an effort to modify their risk management procedures to address the seven deviations identified in EN ISO 14971:2012. If your auditor has twice as much time to review risk management documentation, he will be looking for a summary of hazard identification activities. Hazards should be included as a design input and each hazard should be traceable throughout the risk management process to a specific risk control or controls.