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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 face some of the same challenges in the coming months that orthopaedic 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.”
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 orthopaedic 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:
- BSI Spinal Implants Reclassification Webinar. Accessed: June 21, 2013. https://bsi.learncentral.com/shop/Course.aspx?id=23075
- Silman A. Joint submission to the MHRA consultation on the Revision of European Legislation on Medical Devices. Accessed: Oct. 31, 2013.
- For more information:
- Hamish Forster, PhD, CEng, can be reached at BSI America, 12110 Sunset Hills Rd. #200, Reston, VA 20190, USA; email: hamish.forster@bsigoup.com.
Disclosure: Forster has no relevant financial disclosures.