The Notified Body British Standards Institution (BSI) has launched the Clinical Strategy Review for manufacturers applying for CE marking. (See Exhibit 1.) This new service helps manufacturers ensure ahead of time that their clinical evaluation plan will be acceptable to meet the regulatory requirements needed by the Notified Body.
Exhibit 1: Clinical Strategy Review
Europe Enhances Emphasis on Clinical Evaluations
The clinical evaluation is a critical element in the CE Marking regulatory pathway for placing a new medical device on the European market. Recent revisions to the European regulations now place an even greater demand for thorough clinical evaluation as part of the technical documentation. Orthopaedic manufacturers find the production of supporting data to be challenging, costly and time-consuming. Nevertheless the manufacturer, prior to launching a device, is solely responsible for ensuring that the clinical evaluation is thorough and objective in demonstrating valid clinical evidence of safety and performance.
Increasing Predictability in Notified Body Assessments
Ordinarily, the manufacturer submits a clinical evaluation plan at the end of the product development process as part of the full CE Marking technical document review. With our voluntary modular approach, BSI performs the review after the plan has been finalized, but prior to execution. The BSI Clinical Strategy Review is based upon the manufacturer’s successful achievement of its clinical plan, current legislation and related guidance used at the time of the review, which can change by the completion of an investigation. Early review is of prime importance in technology fields in which there are series of line-extensions and continuous product improvements such as joint replacement implants, bone graft substitutes, fracture fixation devices, etc. It allows for early debate on the choice of performing a clinical trial to support the changes versus relying on existing data, postmarketing information of similar products and literature review.
The coming together of biologics and orthopaedic devices to develop innovative combinations products is an exciting and fast growing segment, but with the opportunity also comes tremendous challenges. Manufacturers determine which regulations apply and what agencies are involved. The Clinical Strategy Review works through these challenges with the manufacturer early, to help them chart their regulatory pathway in the most efficient and cost-effective manner.
BSI provides a written report supplying feedback on the manufacturer’s Clinical Strategy Plan, which the manufacturer can utilize in building technical documentation, thus giving them assurance in moving forward. In addition, knowledge up front provides a cost-effective and timely opportunity to amend strategy if needed.
The Steps to Confidence
The diagram in Exhibit 1 shows a simplified overview of how the BSI Clinical Strategy Review fits into the manufacturer’s clinical evaluation process. Normally manufacturers wait until the end, after all steps are completed, before submitting a Clinical Evaluation to the Notified Body. Most likely the company has already invested considerable time and resources. Unexpected changes at this late stage can result in unexpected costs and significant delays.
“Having the clinical plan reviewed prior to execution reduces risks of unexpected questions or surprises just prior to the planned launch,” notes Ibim Tariah, Technical Director of BSI Healthcare. “If concerns are identified, they can be addressed early, and this places the company in a much better position to meet their time-to-market goals.”This early debate increases predictability of the Notified Body assessment part of the preparation to start placing products on the EU market.
For those manufacturers working on their first products, on new and innovative products and on products for which regulatory requirements are under development, the Clinical Strategy Review service can be embedded in a broader Regulatory Strategy Review, aiming at a higher level to ensure ahead of time that their future submission will be acceptable to meet the regulatory requirements needed by the Notified Body.
The highly trained BSI team of product experts has extensive experience in both regulatory and industry, working with large international firms with diversified product portfolios to small start-ups with a single medical device. As a Notified Body, they successfully balance the requirement to maintain objectivity and independence while providing practical feedback. Companies large or small obtaining clinical strategy agreement with their Notified Body will be seen in the market place as achieving a milestone on the pathway to Europe.
British Standards Institution