The technical documentation that device manufacturers must compile in support of CE marking is governed by Annexes II and III of the EU Regulations on medical devices (EU MDR) and on in-vitro diagnostic devices (IVDR). The structure and contents are reminiscent of the STED (Summary of Technical Documentation) but its generation or maintenance might still be challenging for newcomers or “legacy” device manufacturers.
Decomplix' documentation's compliance includes:
For newcomers, we provide ready-to-use templates for all elements of an EU MDR/IVDR compliant technical documentation.
We conduct detailed gap analysis of your technical file at any stage of compilation, including expert advice to turn “legacy” content or scattered evidence into structured technical documentation.
We tailor technical documentation, adapted to your existing document management system and other relevant QMS processes.
We propose a modular approach to compilation/writing of technical documentation elements, where you can collaborate as much as desired.
To make your technical documentation process smooth and compliant, we offer you tailored gap analyses, 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 reviews, structures, and compiles your technical documentation under the EU MDR/IVDR. We have been assisting numerous medical device and IVD manufacturers get their technical documentation in shape for both self-declared devices and devices requiring CE certification by a Notified Body.
Technical documentation is also expectation management
The technical documentation constitutes the documented evidence of conformity with the General Safety & Performance Requirements (GSPRs) in Annex I of the EU MDR or IVDR. And, where applicable, any harmonized standards or Common Specifications followed as presumption of conformity. A suitable technical documentation must be complete, relevant for the concerned device models, and compliant with Annexes II and III of the EU MDR/IVDR.
Preparing a table of contents and templates out of these Annexes is straightforward but it does not suffice to compile a clear, organized and readily searchable technical documentation. Knowing what information is expected by Notified Bodies and competent authorities, and what level of detail provides sufficient evidence of conformity without requiring too frequent updates is far less easy.
Technical documentation is also expectation management.
Furthermore, many sections of the technical documentation are in fact the output of mandatory Quality Management System (QMS) processes, like risk management, clinical evaluation, or post-market surveillance (PMS). This means that the plans and reports compiled in the technical documentation must be aligned with the corresponding process described in a QMS procedure.
Because the technical documentation is a living set of documents, constantly evolving due to device changes, information gathered in the post-market phase, or regulatory change, maintenance can become cumbersome, and yield awfully patchy documents if not rooted in a systematic change management process. Inconsistencies across the technical documentation are usually the source of major non-conformities in Notified Body’s audits. Manufacturers should identify suitable technical writers and place efforts in ensuring a systematic approach throughout the different sections in the technical documentation.
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.»
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.»