Compliant. Consistent. Aligned with the expectations of Notified Bodies.
Technical Documentation
for Medical Devices according to MDR and IVDR
For many manufacturers, technical documentation has grown over the years – document by document, without any consistent structure. This is precisely what becomes apparent during a review: gaps, inconsistencies and outdated information. We organise your documentation so that it is complete, consistent and ready for inspection – tailored to what Notified Bodies actually expect.
Technical documentation is the heart of every approval
Unclear structures, inconsistent content, or outdated documents quickly lead to queries, delays, or review nonconformities.
Many manufacturers face very specific questions:
Does our technical documentation meet the current requirements of the MDR or IVDR?
Does our technical documentation need to be completely recreated?
What do Notified Bodies or Competent Authorities actually expect during the review?
Not sure whether your technical documentation is up to standard?
We support you with the creation, optimization, and ongoing maintenance of your technical documentation according to MDR and IVDR – whether as a one-off Gap Analysis, project-based support, or with the digitalization of your Technical Documentation.
Have your Technical Documentation reviewedOur services in the area of technical documentation
Not every technical documentation needs to be created from scratch. We support you on a targeted, project-based, or ongoing basis – depending on the baseline status of your documentation.
International market access & regulatory strategies
- Your documentation is fully structured according to MDR or IVDR (Annex II & III) – review-ready from the start
- Your existing documentation is structured and completed without gaps – without unnecessary rebuilding
- Your documentation is digitally accessible and consistently maintained
Review, evaluations & Notified Body communication
- You know exactly where your documentation stands today – and what is specifically missing
- Evaluations by Notified Bodies proceed in a structured manner and without surprises
- Nonconformity Reports from Notified Bodies or the Competent Authority are answered
- You go into audits prepared – not reactively
Interfaces & regulatory evidence
- Your risk management file, usability evaluation reports, and where applicable biological evaluation are complete and review-ready
- Risk management, Post-Market Surveillance, and Clinical Evaluation or Performance Evaluation are consistently interlinked – all interfaces considered
Electronic Technical Documentation (eTD)
- You have selected an eTD tool that is aligned with your business strategy and portfolio and can be meaningfully integrated into your IT infrastructure
- Your digitalization project is conducted in a structured manner and stays within the planned timeframe, resources, and budget
- Your technical documentation is digitally structured, versioned, and review-ready at all times. Redundant information is a thing of the past
- Document architecture and access rights meet the requirements of Notified BodiesMore about regulatory-compliant implementation: [Digitalization in the QM and Regulatory Environment]
- Interfaces to the Quality Management System, Clinical Affairs, and PMS are consistently mapped
- More about regulatory-compliant implementation:
→Digitalization in the QM and Regulatory Environment
Document maintenance
- Your documentation remains permanently compliant through product changes or regulatory updates
- New MDR or IVDR requirements are incorporated early – before they become a problem
Clarity starts with a clear structure.
If you would like to find out how robust your technical documentation currently is and where there may be room for improvement, we can review your documentation together.
Have your Technical Documentation reviewedWhen manufacturers come to us
Before submission to the Notified Body
your documentation must be robust
After a regulatory update
MDR, IVDR, or standards changes have left gaps
Product change
Existing documentation must be updated
Our services
Our customers
Medical Device
manufacturers
Start-ups
Suppliers for medical devices / IVD
Authorities
IVD manufacturers
Investors
Frequently Asked Questions about Technical Documentation
Clear and consistent technical documentation creates confidence in the approval process and facilitates collaboration with Notified Bodies. Structured documentation helps map requirements traceably and avoid queries or delays in the review process.
Technical documentation describes the design, function, safety, and performance of a Medical Device or In Vitro Diagnostic Device.
It forms the basis for the Conformity Assessment and thus for CE Marking.
The requirements are defined in Annex II and III of the MDR or IVDR, respectively, and include, among other things:
– Device Description and specifications
– Risk Management
– Clinical Evaluation and/or Performance Evaluation
– Verification and Validation evidence
– Post-Market Surveillance information
For manufacturers, this means that documentation must be complete, consistent, and traceably structured.
Technical documentation contains all the information that demonstrates the safety, performance, and thus the conformity of a product with Regulatory Requirements. This includes, among other things, device description, risk management, clinical evaluation or performance evaluation, Post-Market Surveillance documentation, as well as verifications, validations, and of course the Declaration of Conformity. It must be clearly structured, traceable, and verifiable at all times.
Not necessarily. In many cases, existing documentation can be revised, restructured, and supplemented to meet current requirements.
The MDR or IVDR requires a more precise structuring of documentation than the former Directive 93/42/EEC or Directive 98/79/EC. When transitioning existing products – so-called Legacy Devices – to MDR-compliant or IVDR-compliant documentation, it may therefore be necessary to reorganize, adapt, or supplement individual sections – but usually based on existing content, not as a complete rebuild.
Parts of the technical documentation only need to be recreated when significant changes to the product or to the Intended Purpose have been made. This is particularly necessary in the area of Clinical Evaluation, as the requirements for Clinical Data have changed considerably. For stable, unchanged Medical Devices with good clinical data, however, the rule is: update rather than rewrite.
Notified Bodies or Competent Authorities conduct a detailed assessment of the Technical Documentation. They specifically review whether the documentation is complete, consistent, and traceably structured and whether all Regulatory Requirements of the MDR or IVDR, as well as normative requirements, are met. All preclinical and clinical safety and performance evidence is examined – including risk management evidence, usability, Biological Evaluation, sterilization, Clinical Evidence, etc., and verifying whether all General Safety and Performance Requirements of Annex I of MDR or IVDR have been assessed and fulfilled.
That depends very much on the initial situation. Here at regular services, we know which aspects are critical during an audit, so an initial review is very quick and takes just a few hours.
Based on this review, we can make a realistic estimate of the time required – ranging from a few days to several weeks.
If further testing is required, the time needed will also depend on the capacity of the testing laboratories. In such cases, the process may take several months.
An update is necessary upon product changes, regulatory updates (e.g. MDR or IVDR), new Clinical Data or performance data, and new findings from Post-Market Surveillance. Technical Documentation is not a one-time document – it must be actively maintained and updated throughout the entire Product Lifecycle. The MDR or IVDR expressly requires manufacturers to keep their documentation up to date continuously. Technical Documentation is re-evaluated, particularly in the context of Recertification Audits, Surveillance Audits, or regulatory inspections. All changes since the last review are examined.
We check whether your technical documentation meets the requirements of the Notified Body – and address any gaps before they become a problem.