CE marking of in-vitro diagnostic medical devices (IVDs)

We take care of the CE certification of your in-vitro diagnostic medical devices.

Overcome regulatory hurdles more efficiently and securely with us.

As a manufacturer of in-vitro diagnostic medical devices (IVDs), you must ensure compliance with the regulatory requirements before placing your products on the market.
The IVDR (Regulation (EU) 2017/746) and the Swiss Ordinance (IvDO) form the regulatory framework for in-vitro diagnostics, imposing stricter requirements than the previous directive (IVDD). They aim to enhance the quality and safety of diagnostics while strengthening public health and patient safety.
To obtain CE marking for IVDs, most manufacturers must undergo a conformity assessment.

Decomplix’ services for the CE marking of In-Vitro-Diagnostic (IVD) include:

Strategy: We provide guidance on regulatory and clinical strategies and processes to ensure an efficient and effective market access.
Risk class assessment: We assess the qualification and classification of IVDs into the appropriate risk classes A to D according to IVDR and help you to classify your products correctly.
Technical documentation: We review technical documentation for completeness and compliance and support you in creating and updating documentation to accurately reflect performance data and safety information.
Market surveillance and vigilance: We support the establishment and management of systems for post-market surveillance and incident reporting, and the implementation of corrective actions and recalls.

Training: We conduct training sessions for manufacturers on IVDR requirements and best practices for compliance.
Under IVDR, we offer you the role of PRRC (Person Responsible for Regulatory Compliance) as an outsourced service if your company qualifies as a ‘micro or small enterprise’ according to the European Commission’s Recommendation 2003/361/EC.
We offer you the role of QMB (Quality Management Representative) as an external service to ensure compliance with EN ISO 13485 for your quality management system.

With our modular support, we adapt to your needs and your pace. As part of our offer, experienced regulatory affairs experts evaluate existing documentation and processes to identify gaps. This includes reviewing which aspects can be considered in your regulatory strategy. We have helped numerous medical device and IVD manufacturers get in shape, whether they have self-declared products or those that require CE certification by a notified body.

Strategic Plan for CE Marking and Market Access of In-Vitro Diagnostics (IVD)

A thorough conformity assessment is one of our first measures to ensure that your product meets the strict requirements of the IVDR (Regulation (EU) 2017/746) as well as the Swiss IvDV. Compliance with these high standards is essential for a successful market launch.

Risk and quality management are a central part of the strategy. The intended purpose of the product determines whether it qualifies as an IVD and into which risk class (A to D) it is classified. This classification defines the regulatory pathway and the level of regulatory scrutiny the product will undergo.

A technical documentation that is carefully prepared and regularly updated is an essential aspect of conformity for IVD manufacturers. Our experts review each technical documentation for completeness and compliance with the requirements of the IVDR. This review ensures that all performance data and safety information are presented accurately and comprehensively. It is crucial not only for obtaining market approval but also for strengthening the confidence of users and regulatory authorities in the quality and safety of the products.

We train our employees to ensure they have the necessary regulatory knowledge.

Manufacturer training in the context of the IVDR is essential to ensure that employees understand the complexity of the regulations and can guarantee a high level of quality and safety for the products. These training sessions help to meet legal requirements, avoid market access restrictions and effectively manage regulatory risks. Through regular training, companies can ensure that their employees remain up to date with the latest legislation, which in turn strengthens internal accountability and minimizes the risk of penalties or costly product recalls.

Market surveillance and vigilance are crucial for the regulatory strategy in the medical technology sector, as they ensure the safety and effectiveness of products after being placed on the market. These systems not only enable compliance with legal requirements by identifying and addressing product defects at an early stage, but they also help to reduce risk and prevent serious health impacts for users. In addition, they promote product improvement and innovation development through continuous feedback and data analysis. An effective surveillance and vigilance system strengthens customer and regulatory authority trust, which sustainably supports a company’s market position.

Contact us

Beni Hirt

Customer Relations & CEO

Beni Hirt has over 15 years of experience in customer relations and project management, particularly in software and business modeling. Beni Hirt builds and maintains partnerships with start-ups, SME, and big entities and supports them to clear regulatory hurdles and shorten the time to market. He is a business administrator and experienced in establishing and running new businesses and models. He also has co-founded and ran one of the most successful Swiss app agencies.

Contact

E-Mail
+41 79 668 02 60

Why Decomplix as your partner

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.

Decomplix operates under a ISO 13485 certified quality management system.
Decomplix’ customers benefit from easy-to-use digital tools with secure and compliant IT infrastructure.
Decomplix stands by as a coach in compliance matters and as the customer’s close contact to Swiss authorities.

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.»

Dr. Corina Matzdorf ulrich GmbH & Co. KG, Germany

«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.»

Eric Tscharner HASA OPTIX, Belgium

«As a premium manufacturer of ophthalmic instruments, we feel very secure with Decomplix.»

Florian Schulz OBERON GmbH Fiber Technologies, Germany

«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.»

José Näf nahtlos GmbH, Switzerland

«Decomplix' Regulatory Support helps us quick and uncomplicated — I can thoroughly recommend it to any medical start-up.»

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.»

Renate Reiss NeoNavia GmbH, Germany

«Due to service quality, regulatory knowledge, and reliability, we can highly recommend Decomplix as CH-REP.»

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.»

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.»

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.»

Nicolas Höfler Groupe Mutuel, Switzerland

«Decomplix gives us the necessary security in the use of software as a medical device during digitalization.»

Susanne Vesterinen RFSU AB, Sweden

«It feels very good to have Decomplix as CH-REP.»

Teija Ålander Orkla – Wound Care, Sweden

«We are very satisfied with the support and helpful knowledge of Decomplix as CH-REP.»

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.»

Benjamin Schlenker Canvys – Visual Technology Solutions, Germany

«With Decomplix as our CH-REP and partner, we feel well-supported. The collaboration is exceptionally professional and efficient.»

Alain Kamm Sanitas Health Insurance, Switzerland

«For our digital health initiatives, we feel we are in safe hands with Decomplix.»

Claudia Handler CARE diagnostica, Austria

«We appreciate the clear procedure, the professional approach, and the uncomplicated cooperation and highly recommend Decomplix as a business partner.»

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