BSI Clinical Strategy Review

The clinical evaluation is a critical element in the CE Marking regulatory pathway for placing a new medical device on the European market. It can be expensive, time-consuming and challenging. The recent revisions of the Medical Device Directives (MDD and AIMDD) place an even greater emphasis on a sound clinical evaluation as part of a technical document submission for all risk classes, especially high risk Class III and Active Implantable devices.

The manufacturer, prior to launching a device, is responsible for ensuring the clinical evaluation is thorough and objective in demonstrating valid clinical evidence of safety and performance. This places a substantial demand on the company to “get it right from the start.” BSI Clinical Strategy Reviews help to ensure that the device manufacturer’s proposed Clinical Plan will be acceptable and sufficient to meet CE Marking requirements needed by the Notified Body. The clinical review usually takes place as part of the full technical documentation review submitted at the end of the process. Our voluntary Modular Approach allows BSI to conduct the review of the Manufacturer’s Clinical Evaluation Plan earlier—at the point when you have finalized your Plan but not yet started its execution.

A High Level of Confidence

Achieving agreement between the manufacturer and their Notified Body is essential in determining strategy and represents a major milestone in helping demonstrate the product launch is on target. This holds true whether you are a multinational corporation with substantial resources or a newly emerging company seeking funding. Our highly trained BSI Product Experts have the knowledge, background and skill to conduct thorough reviews giving you a high level of confidence that your clinical strategy is on-track. BSI provides a written report supplying feedback on the manufacturer’s Clinical Strategy Plan, based on the latest European Regulations, Standards and Guidance. Optional onsite sessions are also available

Improved Time-to-Market

As a manufacturer, you are in a much better position to meet or improve your time-to-market goals having your Clinical Plan reviewed prior to execution. It increases predictability, minimizes risks of unexpected questions, requirements or surprises just prior to the scheduled launch. If concerns are identified they can be addressed early.

The BSI Clinical Strategy Review involves BSI earlier in the process. We provide the feedback you need to gain confidence your Clinical Evaluation Plan will be acceptable and sufficient to meet CE Marking requirements needed by the Notified Body. The manufacturer can utilize this feedback in building their technical documentation giving you assurance in moving forward. In addition, knowledge upfront provides a cost-effective and timely opportunity to amend strategy if needed.

Benefits

• Gain a clear understanding of what the Notified Body expects early in the CE Marking process
• Work with experienced and knowledgeable Product Experts
• Meet timelines by minimizing risks of unexpected questions or requirements just  prior to your scheduled launch
• Achieve a high level of confidence your clinical strategy is on-track
• Receive a BSI Report providing feedback on your clinical plan
• Emerging companies that reach clinical strategy agreement may use it as a milestone for next round of funding

Product Expertise

Our professional, knowledgeable and responsive Team of Product Experts have extensive experience in both regulatory and industry. Backgrounds include research and development, engineers, clinicians, product specialists, microbiologists, quality and regulatory affairs experts. They have in-depth understanding of medical device technologies encompassing:

Working with a Notified Body

BSI is a Notified Body governed by the highest of standards to ensure effectiveness, safety and independence. We are regulated by governmental agencies to provide objective certification that manufacturers’ products demonstrate compliance to the Directives. Accordingly, we are not permitted to consult and must always maintain our objectivity for the good of all concerned. The voluntary BSI Clinical Strategy Review can be started at an earlier stage; however, it is still considered part of the normal review, subject to the same regulations.

NOTE: The Clinical Strategy Review is based on the manufacturer’s successful achievement of its clinical plan, the version of the Directive and related guidance used at the time the review. Regulations and their interpretations may have changed by the time the clinical investigations are complete which may invalidate the review or require updating.

The flowchart gives 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 the steps are completed, before submitting their Clinical Evaluation to the Notified Body. However, unexpected changes at this late stage can result in unexpected costs and significant delays. Involving BSI sooner in the process you can gain a clear understanding of what the Notified Body expects. Whether you are conducting a Literature Review only or one in combination with a Clinical Investigation—you can attain a high level of confidence that your data will be sufficient to meet the Essential Requirements.