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. Therefore, it absolutely pays to set a regulatory strategy in advance.
Decomplix’ CE marking regulatory strategy and gapanalyses service includes:
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.
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.
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.
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.
Contact us
Helena Lacalle
Regulatory Affairs Manager
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.
100+ medical device and in-vitro diagnostic companies of all shapes and sizes trust Decomplix — from startups to corporates, from Switzerland to all around the globe.
Decomplix’ high level of compliance and regulatory knowledge was confirmed by a successful Swissmedic inspection in 2022. Decomplix is one of the few inspected CH-REPs without any non-conformities.
«Being a German high-quality manufacturer for medical devices with more than 110 years of experience and operating worldwide, we feel very safe with Decomplix.»
«Decomplix offers a professional approach and streamlined process for compliance and specific requirements of the Swiss market.»
Jonas Widmer
Balgrist University Hospital, Switzerland
«With the regulatory evaluation of our planning software, we were able to take key steps in product development with Decomplix.»
Renate Reiss
Neodynamics AB, Sweden
«Due to service quality, regulatory knowledge, and reliability, we can highly recommend Decomplix as CH-REP.»
Dominik Gutzler
CytoSorbents Europe GmbH, Germany
«Decomplix as CH-REP is our partner of choice, providing us with a great comprehensive service and allowing us to focus our internal resources on other projects.»
Alain Kamm
Sanitas Health Insurance, Switzerland
«For our digital health initiatives, we feel we are in safe hands with Decomplix.»
Sang-Il Kim
Federal Office of Public Health FOPH, Switzerland
«Decomplix has done an excellent job for the SwissCovid App while working under high pressure. The team is reliable, fast and extremely competent.»
Thomas Farner
Axon Lab AG, Switzerland
«Thanks to Decomplix' great expertise, pragmatic approach and support, we were ready for the CH requirements for IVD/MD importers and CH-REPs within a short time.»
Runa Emura
Konan Medical Inc., Japan
«Decomplix quickly provides us with new and updated information on medical devices in Switzerland. We are very satisfied with their service.»
José Näf
nahtlos GmbH, Switzerland
«Decomplix' Regulatory Support helps us quick and uncomplicated — I can thoroughly recommend it to any medical start-up.»
Matías Hosiasson
Biomedical Devices SpA, Chile
«Decomplix took a pragmatic approach and enabled us to make an informed decision on the regulatory pathway.»
Hemera Beretta
NeuroPro AG, Switzerland
«Decomplix provided valuable expertise for understanding the regulatory framework of medical device, data protection and IT security.»
Pascal Reichmuth
Rikai AG, Switzerland
«Thanks to the comprehensive strategy workshop with Decomplix, we understand how to classify and develop our product Rikai as medical device software and what rules apply in the development.»
Manuel Baumann
Oviva AG, Switzerland
«We benefited tremendously from Decomplix's experience and expertise in working with the Swiss authority, Swissmedic, and with Notified Bodies.»
Markus Piller
Medid AG, Switzerland
«The flexibility, broad-based expertise and the will to always find a suitable solution for our problems as a small MedTech company are qualities we greatly appreciate about Decomplix.»
