To shorten your time to market, we offer expert opinions, specific input with rapid feedback that saves you time in your project and ensures that you are heading in the right direction.
Our support can be structured in a modular manner to suit your needs at your own pace. In our offer, an experienced Regulatory Affairs professional performs a regulatory evaluation of your existing documentation and processes to identify applicable requirements, confirm device qualification/classification, clarify further questions, and check what to consider for the regulatory strategy.

There are several factors to consider when deciding which market to enter with a medical device. Market strategy should not be established without regulatory considerations, and should not be only driven by economic factors like revenue and market share. The attractiveness of a market needs to be weighed with regulatory requirements in mind as the time, cost, and complexity of getting and maintaining a medical device approval cannot be underestimated.

The regulatory strategy should be set up in the early phases of the product development process, as it impacts the market launch, marketing activities, and therefore the business. Moreover, under the EU MDR and IVDR, a strategy for regulatory compliance is a requirement of the manufacturer’s Quality Management System (QMS) and it must include compliance with conformity assessment procedures and those for management of modifications to the devices.
For more information, see our blog article Medical device regulatory strategy – US vs. EU.

Your regulatory strategy is intertwined with your marketing strategy, as gaining access to markets is preceded by regulatory approval. To anticipate the time, cost, and complexity of getting your device approved in a particular market, you (obviously) need to know the regulatory requirements applicable to your device.

Set up your regulatory strategy as early as possible.

In almost all markets worldwide, the risk classification determines the regulatory pathway and, therefore, the level of regulatory scrutiny that applies to your device. To classify your device, you need to have defined its intended purpose and intended user as well as a list of planned device functions. Therefore, a regulatory strategy can only be developed once the preliminary user requirements and outline of product functionality are available.

The regulatory pathway is the cornerstone of your regulatory strategy and, for CE marking, this entails at least an initial opinion on the classification of the device, which in turns determines the conformity assessment route required and whether or not a Notified Body needs to be involved.