Technical documentation’s compliance.

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.

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.

  • For newcomers, we provide ready-to-use templates for all elements of an EU MDR/IVDR compliant technical documentation.
  • We tailor technical documentation, adapted to your existing document management system and other relevant QMS processes.
  • 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 propose a modular approach to compilation/writing of technical documentation elements, where you can collaborate as much as desired.

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.

Technical documentation is also expectation management.

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.

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 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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