When creating and maintaining the TD, the following points should be considered, among others:
- Consistency, in particular, of the purpose.
- An appropriate structure for the technical documentation: clear, organized, easily searchable, and unambiguous.
- Digitization of your documents
- Full verification of your products' claims
- A complete set of documentation. If requirements do not apply to your product, you must not ignore them, you must justify their absence.
- Not to forget the updates resulting from the post-marketing surveillance (Annex III of the IVDR).
The primary purpose of the Technical Documentation is to demonstrate compliance with the regulatory requirements for market access; in Europe, this means compliance with the Essential Requirements according to Annex I of the IVD and, from May 2022, with the Essential Safety and Performance Requirements according to Annex I of the IVDR.
Minimizing liability risks
Another aspect, however, should be equally taken into account: Technical documentation is an important tool for minimizing liability risks. Only if you know exactly whether an incident in the market is due to a design defect or can be limited to the batch, can you take appropriate and reasonably limited measures.What does a suitable TD structure look like?
You can base the structure of the TD on the 7 chapters of the IVDR from Annex II & III:
- Product Description and Specification. Including variants and accessories
- Information to be provided by the manufacturer
- Information on design and manufacture
- Essential safety and performance requirements
- Benefit-risk analysis and risk management
- Product verification and validation
- Technical documentation on post-market surveillance
If you also sell your products outside the EU and therefore have to consider international requirements for the structure of the documentation, it is important to take this into account right from the start. Depending on the target country, the product information must be prepared and made available differently.We are also happy to support you in the selection of a Notified Body. Enquire now!
Of course, a regulatory software solution is a thought model that needs to be considered. Our DigiLab will help you choose the right software.
Documentation during development
For existing products, it is necessary to retrospectively prepare the documentation according to IVDR. This often involves searching for and checking old data records, closing gaps, and reorganizing the technical documentation.For new development products, on the other hand, it is easier for us. Here we can start from the beginning with development-accompanying, regulatory-compliant technical documentation: eliciting requirements, deriving specifications, and creating verification and validation plans from the resulting design input, the results of which then provide the design output.Planning, implementation, and reporting are carried out in the same way as required in chapter 7 of EN ISO 13485: Documentation in the specifications, requirements specification, study plans and reports, and digital and consistent from day one. And don't forget risk management - this also needs to be taken into account right from the start.
Classification
Classification rules must be applied for the classification of IVDs according to the IVDR. According to the classification of the IVD, different requirements on the conformity assessment procedure and the Involvement of the Notified Body has to be followed.More on the new IVD classification.
Post-market surveillance - PMS for IVDs.
All product files must be maintained, and updated with the findings of post-market surveillance (PMS) throughout the product lifecycle. The effects of changes to the IVD or manufacturing processes must also be documented accordingly. Caution! If you make use of the transition periods and your product is still on the market under the IVDD, no significant changes may be made. Significant changes to an IVDD product mean that a new approval under the IVDR is necessary.Accordingly, technical documentation is a real-life document that needs to be continuously maintained. If your technical documentation is well-structured and searchable, you will facilitate maintenance and save a lot of time in the long run. The IVDR explicitly requires that "the technical documentation to be drawn up by the manufacturer and, where necessary, its summary (...) be presented in a clear, organized, easily searchable and unambiguous form".Whether it is the creation and optimization of your market observation process or the maintenance of the technical documentation: We are happy to support you!Schedule your free initial consultation with us now.
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