Transition from IVDD
to IVDR (in vitro diagnostics)

For a structured and efficient transition to the new legislation.

We support you in the regulatory strategy for your IVDs.

The transition from the In Vitro Diagnostic Directive (IVDD) to the In Vitro Diagnostic Regulation (IVDR) in the European Union and the corresponding Swiss Ordinance (IvDO) marks a significant step in the regulation of diagnostic products. The IVDR, which has stricter requirements than the previous directive, aims to improve the safety and performance of in vitro diagnostics.

Companies must now address the new requirements to ensure the conformity of their products.

Development of the regulatory strategy for the transition from IVDD to IVDR.

Gap analysis: We conduct a comprehensive gap analysis of your current products and processes to identify necessary adjustments for IVDR compliance. This includes a review of your technical documentation, quality management systems and clinical evidence.
Classification: We review, classify and/or reclassify your devices according to the new IVDR classification rules, which often require a higher classification than under the IVDD, to ensure compliance.
Quality Management System: We create and update your documentation to ensure a comprehensive quality management system that is effectively integrated into your daily operations, in accordance with IVDR requirements.

Clinical evidence: We support you in evaluating and collecting clinical data, because the IVDR requires a higher level of detail.
Conformity procedure: We help you find a notified body in good time, as the IVDR has stricter certification requirements and it is crucial to communicate with these bodies early on to understand their requirements and timelines.
Post-market: We provide you with instructions and templates to adapt your post-market surveillance (PMS) and post-market performance follow-up (PMPF) activities in accordance with the IVDR.
Training and awareness: We train and inform all relevant employees about the changes to ensure compliance with the IVDR.

Our support can be structured in modules to meet your needs at your pace. Experienced regulatory affairs experts assess the current state of your regulatory assumptions and answer specific questions to uncover potential misunderstandings and identify applicable requirements and their impact on your compliance.

The IVDR introduces a risk-based classification system that categorizes devices into classes A (low risk) to D (highest risk). Most devices now require certification by a notified body. In addition, the requirements for clinical evidence have been increased to ensure the safety and performance of the devices. The introduction of Unique Device Identification (UDI) improves the traceability of in vitro diagnostic medical devices. Manufacturers, importers and distributors must adapt their processes to these new requirements to ensure compliance.

Key steps for a successful transition include updating technical documentation, implementing a robust quality management system in accordance with ISO 13485 and conducting any necessary performance studies. The IVDR also provides for specific transition periods that vary depending on the risk class of the product. To meet the new regulatory requirements and ensure compliance, it is advisable for manufacturers to familiarize themselves with the provisions of the IVDR at an early stage.

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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

Email
+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.»

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.»

Florian Schulz OBERON GmbH Fiber Technologies, Germany

«Decomplix offers a professional approach and streamlined process for compliance and specific requirements of the Swiss market.»

Nicolas Höfler Groupe Mutuel, Switzerland

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

Renate Reiss NeoNavia GmbH, Germany

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

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.»

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.»

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.»

José Näf nahtlos GmbH, Switzerland

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

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.»

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.»

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.»

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