What is the Regulatory Strategy Review?
BSI provides a written gap analysis report against the relevant requirements, supplying feedback on your Strategy Plan based on the latest European Regulations, Standards and Guidance. Based on the information supplied, this report can help identify deficiencies within your technical documentation and compliance with the regulatory requirements.
In addition, knowledge upfront provides a cost-effective and timely opportunity to amend your strategy if needed.
BSI Regulatory Strategy Review - the modular approach
The Regulatory Strategy Review is made up of four subsets, that you can choose for review. You can request more than one service, all of the services are available only as part of the BSI CE marking process; only Manufacturers who have committed to CE marking their product with BSI can make use of the service. In line with BSI's policy on consultancy the early review is a gap analysis between what the manufacturer proposes and the requirements of the current Directives, Standards or Guidance. The Regulatory Strategy Review is available through BSI UK Notified Body, 0086.
As a manufacturer, you are in a much better position to meet or improve your time-to-market goals having your regulatory plan reviewed against the requirements 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 on in the development cycle.
BSI's policy on consultancy
Notified Body personnel (whether directly employed or subcontracted) shall not offer or provide (or have offered or provided) consultancy or advice to the manufacturer, the authorised representative, a supplier or their commercial competitor as regards the design, construction, marketing or maintenance of the products under assessment.
The review process
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 Medical Device Directives (MDD and AIMDD), place emphasis on a sound clinical evaluation as part of a technical document submission for all risk classes, especially high risk Class III and implantable devices.
As a Notified Body, BSI's Clinical Strategy Review will identify shortcomings or potential pitfalls in manufacturers' clinical strategy or literature data, which do not meet the requirements outlined in the relevant Directives, Standards and Guidance used by the Notified Body. We offer this Service for the full range of Medical and Active Implantable Devices.
Note 1: CSR cannot be completed on the Medicinal substance in a Device Drug Combination product.
Note 2: The Clinical Strategy Review is based on the manufacturers' successful achievement of its clinical plan, the version of the Directive and related Guidance used at the time to review. Regulations and their interpretations may have changed by the time the clinical investigations are complete which may invalidate the review or require updating. BSI will not perform more than one CSR for a given device.
Note 3: BSI is expressing our Notified Body opinion on the data that we might anticipate to be acceptable to support CE marking based on the information shared, however, within EU Member States approval of proposed clinical investigations and the supporting protocols/plans is the responsibility of the local Competent Authority. BSI cannot review a proposed Clinical Investigation Plan, this needs to be agreed with the relevant Competent Authority.
The classification of medical devices is a ‘risk based’ system based on the vulnerability of the human body taking account of the potential risks associated with the devices. This approach allows the use of a set of criteria that can be combined in various ways in order to determine classification, e.g. duration of contact with the body, degree of invasiveness and local vs. systemic effect.
These criteria can then be applied to the complete range of different medical devices and technologies. These are referred to as the ‘classification rules’ and are set out in Medical Device Directives.
It is recognized that although the existing rules will adequately classify the vast majority of existing devices, a number of products may be more difficult to classify. Such cases may in particular include devices which are borderline cases between two different classes of medical devices. In addition, there may be devices that cannot be classified by the existing rules because of their unusual nature or situations where the classification would result in the wrong level of conformity assessment in light of the hazard represented by the device.
It is critical to identify the classification of the your product early on in the design process, so if you have a borderline product or just need clarification that your current classification will enable your products to meet the requirements of the directives this service can provide you with the analysis required.
Biological Substance Review
BSI recognizes that regulatory requirements for manufacturers of medical devices incorporating materials of biological origin (e.g. animal tissue / derivatives, human blood derivatives) can be challenging. BSI understands that the utilization of materials of biological origin in your device can bring added benefits but that the regulatory process will be subject to increased scrutiny.
Additional demands include justification for the use of the tissue or derivative, and information relating to sourcing and processing controls.
Early review of your strategy will ensure your plans will meet the strict requirements in this complicated area.
Note: BSI is expressing our Notified Body opinion on the data that we might anticipate to be acceptable to support CE marking based on the information shared, however, within EU Member States approval of proposed clinical investigations and the supporting protocols/plans is the responsibility of the local Competent Authority. BSI cannot review a proposed Clinical Investigation Plan, this needs to be agreed with the relevant Competent Authority.
Note: The Clinical Strategy Review is based on the manufacturers' successful achievement of its clinical plan, the version of the Directive and related guidance used at the time to review. Regulations and their interpretations may have changed by the time the clinical investigations are complete which may invalidate the review or require updating. BSI will not perform more than one CSR for a given device.
Note: The Regulatory Strategy Review service is subject to reasonable efforts made by the manufacturer following the review to proceed with CE marking application using BSI as the Notified Body. The Strategy Review is pursuant to an application for CE marking. In the event that an application for CE marking with BSI has not been made, The Notified Body may be obligated to inform the Competent Authority that the application has been withdrawn, and include details of the review outcome.