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Companies should plan now for proposed spine implant reclassification in Europe
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Due to the proposed reclassification of spinal implants sold in Europe, spine implant manufacturers — including many firms based in the United States — face some of the same challenges in the coming months that orthopedic companies had when total joint replacement prostheses were reclassified in Europe in 2007. However, the date of the spinal implant reclassification remains uncertain.
“The new regulations could start transitioning as early as 2014 or 2015, and the transition may occur as quickly as 18 months for medical device compliance,” Paul Brooks, senior vice president for BSI Healthcare Solutions, which is a notified body (NB) that assesses medical device compliance and CE Marking in the European Union, stated in a press release.
In a joint submission to the Medicines and Healthcare products Regulatory Agency, the British Orthopaedic Association and Arthritis Research UK organizations wrote, “We support the re-classification of spinal disc implants bringing this form of implant within class III.”
Hamish Forster
Changes ahead
Companies that manufacture these implants will likely need to initiate some key changes to have the design dossier for their products reviewed well before the reclassification goes into effect, according to Hamish Forster, PhD, CEng, product expert, Orthopaedic & Dental Team at BSI Healthcare Solutions. He urged orthopedic firms to begin preparations now to meet the reclassification requirements. During a BSI webinar about the proposed reclassification, he suggested they work with a NB that is experienced in this area and preferably one that was involved with the total joint replacement reclassification process.
“We have the resources and capacity to cope with another reclassification exercise, but don’t leave the submissions too late and planning is critical,” Forster said.
The closer it gets to the reclassification deadline, the more design dossiers that will need to be reviewed and the harder it will be for the NBs to review them due to the sheer volume of work this represents, Forster said, noting that at one point during the ramp-up period prior to total joint implant reclassification in Europe, BSI had about 150 reclassification dossiers under review at once.
Definition of spinal column
During the webinar, Forster discussed the Annex VII, rule 8 section of the draft medical device directive that relates to these products. He said a definition of the term “spinal column” as it is used in the directive would be helpful overall.
The wording of the medical device directive concerning spinal devices impacted by the proposed reclassification notes that spinal disc replacement implants and implantable devices that come into contact with the spinal column are now class III in the draft regulation, Forster said.
These devices were previously class IIb, a lower risk product class.
“A definition is something, in my mind at least, that is definitely lacking for the spinal column term within the draft medical device regulation,” Forster said.
Design dossier
Forster’s suggestions to companies for a streamlined device reclassification process included choosing sensible product families for each dossier submitted.
“Design dossiers should be submitted for each family of products. Avoid bundling multiple brands and product families into a single dossier. This is not going to hasten the review,” he said during the webinar.
Newer devices are more likely to have complete, up-to-date documentation and documented clinical evaluation reports, Forster said, and documenting the older spine implants in a company’s product line could require more work.
“You may wish to discuss sensible design dossier construction with your notified body’s scheme manager,” he said.
“A strategic commercial review is another important point that manufacturers will need to consider. The process of choosing what devices to submit for design dossier review should include a product portfolio and strategy planning,” he said.
This may also be an ideal time for companies to determine whether all their spine implants are strategically important in Europe and which can be removed from the product line in the near future. Forster said assessment is critical because it may be difficult to adequately support older devices or products with low sales volume with the type of design verification, post-market surveillance and clinical data required under the new regulations.
He said a dossier submission that is comprehensive and well-formatted is “a vital part of straightforward and timely reviews” and suggested including an executive summary and creating single, searchable PDF files with bookmarks to facilitate a faster review.
Product description
One aspect of the executive summary that Forster discussed was the product description, which should be simple, but thorough. For example, it should mention what the implant is made of, such as polyurethane or titanium, if it includes any special coatings or components, and how it is fixed. In the description, companies should explain in detail the principle of operation or mode of action of the device in question, “especially if it is not obvious,” Forster said.
They should include the Global Medical Device Nomenclature code.
“The design philosophy is often something that is helpful to mention,” Forster said. – by Susan M. Rapp
References:
Silman A. Joint submission to the MHRA consultation on the Revision of European Legislation on Medical Devices. Accessed: Oct. 31, 2013.
For more information:
Disclosure: Forster has no relevant financial disclosures.
Perspective
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Jean Charles Le Huec, MD, PhD
The upcoming rules for total disc replacement (TDR) and other implants are not so bad. Innovation is important to improve the treatment we can offer our patients, but it is important to provide innovations with high-level evidence for efficacy. This was not always the case. Some innovations based on a single surgeon’s experience were promoted without good studies to support the claims.
Future treatments for spine diseases need to at least show superiority to commonly used therapies. The prospective randomized FDA TDR studies were noninferiority studies, except for the Maverick lumbar TDR (Medtronic; Memphis, Tenn.) study, and long-term follow-ups of cervical and lumbar TDRs do not show strong evidence of superiority today. In some studies 45% or more of patients were lost to follow-up.
It is important to support innovation and new therapies. However, prospective, randomized studies should not be performed solely for a commercial purpose, to obtain product approval or reimbursement. They should be conducted to show superiority compared to the existing solutions based on available evidence. Therefore, the new rules should help improve quality and not restrict innovation.
Perspective
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Richard D. Guyer, MD
While the decision to upgrade disc replacement is somewhat surprising in view of its nearly 30-year history and implantations in the hundreds of thousands throughout the world, it is important to have clinical data that support the use of those devices that are being used or developed. We have had excellent 7-year FDA investigational device exemption (IDE) follow-up data in the U.S. supporting the safety and efficacy of the lumbar ProDisc L prosthesis, which is the only one available for use. The data also show adjacent segment surgery is done less than fusion surgery, which is one of the primary advantages of motion preservation. The Charité disc prosthesis, the other approved lumbar disc replacement implant, was taken off the market not for safety reasons, but because surgeons were not using it. We do not have access to the latest generation discs that are compressible, such as the M6.
It is interesting to note that the FDA is considered to be so restrictive that many feel innovation is being stifled and companies are unwilling to support new technology requiring IDE studies. These IDE studies cost about $100 million and it takes 12 years or more for approval. In the past, Texas Back Institute has been involved in four to five FDA IDE studies per year and currently there are none. Now it appears the European regulatory agency is moving toward the FDA philosophy. Unfortunately, FDA studies are so restrictive that in many cases they do not represent the mainstream or real life practice. I am totally in support of providing clinical data in the dossier, but if studies similar to the FDA IDE studies are being considered in Europe, future innovation will be also be further stifled in Europe and patients will suffer, as well. I think as long the product is proven to be safe, market forces and clinical studies which may include registries will vet the effective and best devices.
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