Rethinking IVDR Technical Documentation – Part 1 of 4

Introduction

IVDR technical documentation is more than a collection of documents. It is a continuously evolving body of regulatory information that must remain complete, consistent, and traceable throughout the device lifecycle. In this four-part series, we examine how digitalization, regulatory logic, and AI can support that challenge without replacing expert judgement. 

Most IVD manufacturers no longer work on paper. Technical documentation is created and structured in Word and Excel, reviewed in document management systems, and exchanged as PDFs. In that sense, everything is already digital. 

But the way work happens often is not. Information is still requested by email, copied between files, reconciled during review cycles, and rediscovered when something changes. The files are digital-but the regulatory information inside them is still treated as static text. 

Under the IVDR, this distinction matters. Article 10(4) requires manufacturers to keep technical documentation continuously up to date, including Annex II and III elements (Regulation (EU) 2017/746, Article 10(4)). These annexes expect documentation to be clear, structured, searchable, and unambiguous (Annex II and Annex III, IVDR). The real challenge is therefore not document creation, but maintaining consistent information across the entire lifecycle of the device. 

A Digital Document Is Not Yet Actionable Information 

Word, Excel, PDFs, and document management systems are not the problem. They are essential tools for writing, reviewing, approving, and exchanging regulated content. 

The limitation appears when a file becomes the only place where a regulatory fact exists. 

Take a simple example: a PDF states that the specimen type is EDTA plasma. That is readable and correct. But the file does not show that this value may apply only to certain device variants, is repeated across multiple documents, is linked to specific performance evidence, and should trigger a review in many different places throughout the whole device file if changed. 

For regulatory work, information must be more than readable-it must be usable. A value like specimen type should be traceable across devices, linked to related evidence, reusable in different contexts, and capable of triggering downstream impact when it changes. 

This is the key difference: digitizing documents versus digitalizing regulatory information. 

One Fact, Many Documents 

Technical documentation is full of repeating information: intended purpose, analyte, specimen type, intended user, device configuration, components, performance claims, and limitations. 

These appear across device descriptions, risk management files, performance evaluation, GSPR documentation, labeling, IFUs, and post-market records. The wording as well as the context may differ, but the underlying facts must stay aligned. 

In document-centric processes, reuse usually means copy and paste. Each copy becomes its own editable version. It may be updated later, by someone else, under a different review cycle. 

The result is familiar: each document is controlled, but the system as a whole drifts out of alignment. 

MedTech Europe has highlighted this burden of repeated compilation and the risk of divergence when shared content is maintained at document level (MedTech Europe, “Position Paper on Digitalisation of Technical Documentation”, 2025). It also notes that while tools exist, approaches remain fragmented, and standardization is still limited. 

Technical Documentation Starts Before Writing Begins 

Regulatory Affairs may coordinate technical documentation, but the information itself comes from many places: R&D, quality, manufacturing, product management, software teams, performance evaluation, risk management, suppliers, and external partners. 

This makes information gathering a core workload – not a side task. 

Key questions appear early and repeatedly: 
Who owns the information? What is the authoritative source? Has it been approved? Which variants does it apply to? Has it changed since its last use? Where else is it already embedded? 

The scale differs between organizations, but the underlying problem is the same: information must move reliably from its source into every regulatory context where it is needed. 

The Real Challenge Appears When the Device Changes 

A document-based approach often looks manageable until change happens. 

Imagine a component is replaced-either upgraded by the same supplier or substituted with an equivalent from another. Depending on the change, this may affect: 

• device description and configuration 

• supplier documentation 

• design and manufacturing information 

• risk management 

• performance evidence 

• GSPR documentation 

• labeling and IFUs 

• post-market activities 

The real challenge is not deciding what is impacted. It is identifying everything that might be impacted. 

A folder search is not enough. Components may be named differently, referenced indirectly, or embedded in functional descriptions rather than explicit mentions. 

This is where digitalization becomes relevant: not to make decisions, but to connect and visualize effects of the change and all potentially affected documents so that experts can assess it properly. 

The Industry Is Not Starting from Zero 

This is not a new idea. The direction is already visible. 

MedTech Europe’s 2025 position paper proposes managing recurring technical documentation content at a more granular level rather than only at document level. It also acknowledges that while tools exist, the ecosystem remains fragmented and lacks full standardization. 

The Medical Device Knowledge Units initiative (MDKU) through DIN SPEC 91509:2026-03, takes another step by introducing a structured data-model approach for intended-purpose-related information under the MDR. It is explicitly a first iteration, with IVDR-specific expansion planned later. 

Together, these efforts show a clear direction – but also why progress is complex. Structured data, harmonized terminology, software tools, and exchange standards are related, but not interchangeable. Each solves only part of the problem. 

What Can Be Improved Today

Digitalization does not require full automation of regulatory judgement. Value already exists in the “in-between” work: collecting, comparing, reusing, tracking, and updating information. 

Practical improvements include: 

• structured collection of information from responsible owners 

• identification of approved source data 

• reduction of uncontrolled copying 

• comparison of values across devices and versions 

• detection of inconsistencies 

• visibility of where information is used 

Automation can also support impact analysis, routing of review tasks, and more consistent generation of recurring content. 

But boundaries matter. Software can flag and support-it should not decide whether a change is safe, compliant, or requires new evidence. Those decisions remain with qualified professionals. 

Documents Remain, but Their Role Changes 

IVDR technical documentation will always include human-readable documents. They are required for review, approval, and regulatory exchange. 

The opportunity is not to remove documents. It is to stop treating them as isolated containers of truth. 

Word files, Excel sheets, and PDFs are digital. Digitalization begins when the information inside them becomes structured, connected, reusable, and responsive to change. 

The first version of a technical file can often be assembled manually. The real test is what happens next: does it stay consistent when components, suppliers, claims, or evidence change? 

That is the challenge of change impact-and the focus of the next article.

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*We have compiled the above information to the best of our knowledge, yet our blog entries do not constitute expert advice and cannot substitute your own examination of the legal situation applicable to you and your institution.