CE marking regulatory strategy and gap analyses.

Anyone who develops and wants to sell a medical device must make a careful decision about the target markets. In addition to commercial decision criteria, such as revenue and market share, regulatory requirements are also decisively important. Not taking these into account may result in exploding costs and timelines in product development — the product may not reach the market at all.

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.

  • We provide strategic plans including estimated timelines and costs to choose the most efficient regulatory pathway to CE mark.
  • We elaborate regulatory options and their implications, in consideration of your product’s intended features/claims.
  • We identify potential compliance show-stoppers in your project.
  • We evaluate whether you need to perform a clinical study for your CE marking, one of the most expensive and time consuming activities on the way to market.
  • We help you design a compliant supply chain for placing on the market CE-marked products.
  • We review your intended labeling/claims and deliver relevant proposals to balance compliance and marketing expectations.

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.

Set up your regulatory strategy as early as possible

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.

Set up your regulatory strategy as early as possible.

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.

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.

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.

Contact us

Helena Lacalle

Regulatory Affairs Director

Helena Lacalle is a Regulatory Affairs professional with over 20 years of experience in strictly regulated fields like medical devices and pharmaceuticals. Helena Lacalle holds a pharmacist degree from the University of Barcelona, a Master degree in Statistics from the University of Neuchatel, Switzerland, and has strong language skills in English, French, and Spanish. With her extensive regulatory expertise, she supports Decomplix’ customers both on strategic levels and on detailed regulatory questions.

Contact

helena@decomplix.com
+41 79 929 75 42

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