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.
IVD Strategy Review
The IVD Directive lists “Essential Requirements” to which all IVDs must comply before being placed on the market. These requirements address the design, production, labelling and instructions for use.
BSI offers regulatory strategy review to BSI customers who require their performance evaluation protocol to be reviewed prior to execution.