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.

 


The next document I review is the postmarket surveillance (PMS) plan. Some companies do not have a product-specific PMS plan. Instead, these companies include a copy of their PMS procedure in the Dossier. In addition, the DD will often be missing scheduled PMS reports. For a DD, you need a product-specific PMS plan within your PMS procedure or as a stand-alone document. This plan should indicate what information will be gathered and how frequently it will be reviewed and analyzed. There is also a current trend of greater scrutiny regarding the requirement for PMCF studies as required by Annex X, 1.1c of the MDD. In January 2012, MEDDEV 2.12/2 rev 2 was released and companies with devices that were CE Marked on the basis of substantial equivalence are being asked to provide a PMCF study protocol or justify the reasons for no PMCF study.

The third document I focus on is the Clinical Evaluation Report (CER). The CER was optional as Essential Requirement (ER) 14 up until the M5 version of the MDD was implemented in 2010. Most companies include a literature review instead of a clinical study, but most CERs fall short of the requirements of MEDDEV 2.7/1 rev 3. For example, the CER rarely includes a copy of the literature search protocol, and there is not always a critical analysis and grading of each article for clinical relevance.

The fourth area of focus is design validation. Often when an OEM launches a product on the market, there will be clinical data for the range of product. However, as time passes, the company will have line extensions. For spinal implants, manufacturers will typically launch a new product family with a range of sizes that fits the needs of 90 percent of the market. If the product is successful, then the product line is often extended by adding smaller or larger implant sizes. When this is done, the company needs to reassess which size or sizes represent the worst-case scenario for each type of failure mode, and this documentation must be completed before the change.

Policy for Significant Change Notification
Prior to 2007, companies struggled with the decision of which design changes required notification of change to their NB. For a company with an Annex II.3 Full Quality Assurance Certificate, there is no requirement to notify the NB of most design changes for a Class IIb product. NB-MED 2.5.2/ rec 2 is the guidance document I recommend to clients for determining when the NB should be notified of significant changes. This document dates back to 2000, and the guidance is still active.

When companies have a Class III product, however, they must now submit a supplemental DD for each design change. Even label changes and line extensions require supplements. Since each change will require a supplement, it is important to have a DD that is extremely well-organized with a table of contents that clearly identifies which documents were updated. If your company does not have this type of organization, then the entire DD will need to be re-submitted and approval of supplements will take longer. This also costs more.

The Transition Deadline
The transition deadline for reclassification of spinal implants is expected to be one year from approval of the EMDR (i.e., late 2015 or early 2016). This will place a huge burden on the technical reviewers at the NBs to review spinal DDs during 2015, and a backlog of new spinal implant applications is likely. It is also possible that some OEMs may not be able to use their current NBs, who may not be recommended to be one of the few SNBs. Therefore, OEMs with spinal implants on the market should be proactive and start planning these changes now.

“In theory, there should be little difference.”

As part of my preparation for the article about spinal implant reclassification for CE Marking, I wanted to speak directly with Notified Bodies that review Technical Files and Design Dossiers. Bassil Akra, Ph.D., of TÜV SÜD and Hamish Forster, Ph.D., of BSI were kind enough to answer my questions directly and agreed to let me publish their comments. At the beginning of my call with Hamish, I made the statement that you see above. I wanted to know if the NB experts agreed with this statement: “In theory, there should be little difference.” The other two possible outcomes of my discussions with these experts were: 1) emphasize the word “theory,” or 2) emphasize the word “little.”

Hamish agreed with the statement, and I don’t think he places emphasis on either word. Bassil is a clinical expert, so my question to him focused on the review of clinical evaluation reports. He replied, “There is no different level in our review of clinical evaluations; regardless the classification Class IIa/b or Class III, the requirements of the directive have to be fulfilled.” I believe that BSI cannot make the same statement, because MHRA, the U.K. competent authority, requires additional documentation to be completed for the review of clinical evaluations. TÜV SÜD is governed by the German competent authority, and therefore the requirements for documenting a review of clinical evaluations would be slightly different.

These slight differences are the primary reason that the European Union is developing new European Medical Device Regulations instead of the current New Approach Directives. Another goal of the proposed EMDR is to ensure that all of the NBs conduct thorough reviews of Technical Files and Design Dossiers. Team-NB, of which TÜV SÜD and BSI are both members, has created a Notified Body Code of Conduct. This new code of conduct mandates that a Design Dossier review must last a minimum of five days in duration. This is an important point, because Hamish estimates that the typical review time devoted to a Design Dossier is “at least double” the time spent on the review of Class IIb technical files.

Spinal implants are currently classified under the current Medical Device Directive as a Class IIb device requiring a technical file. NBs sample Technical Files, but companies with an Annex II.3 CE certificate are allowed to make design changes to Class IIb devices without prior approval from the NB. Therefore,
it is possible that a specific file may not be sampled for several years. During my interview with Hamish, he commented that there was a key point missing in my March BONEZONE article: “The vast majority of metal-on-metal implants that were placed on the market in EU were CE Marked as Class IIb prior to the up classification in September 2007.” This fact is a perfect example for why the EU has decided to reclassify spinal implants as Class III devices that will require pre-approval by a Special Notified Body for any future design changes.


Robert Packard is a regulatory consultant with 20 years of experience in the medical device, pharmaceutical and biotechnology industries. Robert served in senior management at several medical device companies, including President and 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 to 2012, he was a lead auditor and instructor for one of the largest Notified Bodies. Robert’s specialty is regulatory submissions for high-risk medical devices, such as implants and drug/device combination products for CE Marking applications, Canadian medical device applications and 510(k) submissions. The most favorite part of his job is training others. He can be reached at This email address is being protected from spambots. You need JavaScript enabled to view it..

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