Regulatory strategy review for medical devices in Europe

BSI's Regulatory Strategy Review - keeping you on track

Regulatory strategy review medical devices BSIAchieving agreement between a manufacturer and their Notified Body is essential in determining regulatory strategy and represents a major milestone in helping to 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 capital.

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 regulatory strategy is on-track.


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.

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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, our clinical strategy review can help to ensure that the device manufacturer’s proposed Clinical Plan will be sufficient to 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, Active Implantable and In Vitro Diagnostic Devices.

Note: Clinical Strategy Review (CSR) cannot be be completed on the Medicinal substance in a Device Drug Combination product.

Classification Review

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.


Why choose BSI for your Regulatory Strategy Review?

  • Gain a clear understanding of what the Notified Body expects early in the product development process.
  • Experienced and knowledgeable Product Experts.
  • Meet your timelines by minimizing risks of unexpected questions or requirements just prior to your scheduled launch.
  • In the early stages, achieve a high level of confidence your regulatory strategy is on-track.
  • Receive a BSI Report of our review against the requirements for your plans on your plans.
  • Emerging companies that reach clinical strategy agreement may use it as a milestone for the next round of funding.
  • The RSR increases confidence and predictability of an inherently unpredictable regulatory process.

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.

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.