We work with you to create robust regulatory strategies that feed exciting business plans.
A well-constructed regulatory strategy is key for business planning and project management. It provides a roadmap to successful market approval and is invaluable for investor confidence or boardroom buy-in. It influences the development pipeline and regional roll-out so is tied in with the business strategy.
We help companies with range of strategic planning activities including:
The regulatory strategy for a product is a geography-specific plan that determines whether a product fits the relevant definitions to be classed as a device or diagnostic, identifies the regulations and standards that apply to the product and outlines the work that will be needed to obtain market approval. Determining the classification of the device is key to this process.
First and foremost a good regulatory strategy reduces the risk of unfavourable review by authorities, saving invaluable time and cost. It should define the first viable launch product and signpost the pipeline of product expansions. It will highlight differences between regions such as between CE mark and FDA approval and this can influence commercial roll-out plans.
Our strategies and Classification Determinations are based on years of experience implementing the classification rules and guidance. Many classification determinations are straightforward to make but some require a careful review of guidance documents, precedent or even legal proceedings. We work with you to identify options to maximise the benefits of your technology.
US regulatory strategy starts with product classification. Despite the FDA’s comprehensive classification database, there is sometimes more than one option to consider. Most devices and IVD’s require a 510(k) Premarket notification with careful selection of a predicate. For devices where no predicate exists to build a 510(k) file, but which are not high enough risk that they should be in class 3, a De Novo submission can be a useful way to progress to market. We have much experience in using this pathway where appropriate.For some applications the FDA pre-submission process can be very useful for initially engaging the FDA and obtaining feedback on any pertinent questions on the development and regulatory review of the device.
Our strategies for medical device CE mark approval to MDR, (EU) 2017/745 or IVDR (2017/746) always make use of the most up-to-date and relevant standards and guidance documents such as the guidance MEDDEVs for the medical device directive or the MDCG endorsed guidance under the MDR. We have experience across IVDs, software, implants, devices containing a drug and other categories. We can create parallel strategies to cover the appropriate application to the UK for UKCA approval.
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