IVDR - Repetitions and Constant Déjà Vus...

Marie Rogowski
October 26, 2023
In Vitro Diagnostic Regulation
"Writing a technical documentation feels like a constant Déjà vu..."

Do you know how often the IVDR asks for the intended purpose?

In the In Vitro Diagnostic Regulation (IVDR), the intended purpose of a product holds crucial significance. It is the manufacturer's determination of what a product can do and what it is intended for. The intended purpose influences classification, clinical evaluation, and post-market activities.

This is a small collection of all the times the IVDR asks you to state your intended purpose:

  1. In the Summary of Safety and Performance (Article 29)
  2. On the label (Annex I, Chapter 3)
  3. In the Instructions for Use (Annex I, Chapter 3)
  4. In the Technical Documentation (Annex II)
  5. On the Declaration of Conformity (Annex IV)
  6. In the Performance Evaluation Plan (Annex XIII)
  7. In the Performance Evaluation Report (Annex XIII)
  8. In the Clinical Performance Study Plan (Annex XIII)
  9. Investigator's brochure (Annex XIV)

But wait, there is more?

And these are just the locations explicitly required in the IVDR. For instance, think about your Post-Market Surveillance (PMS) Plan. Shouldn't this vital document also include clear and consistent information about the intended purpose? Ensuring that PMS aligns with the declared intended purpose can enhance our ability to monitor the safety and performance of our products in the market.

Moreover, if your business extends beyond the European Union, you'll likely encounter regulatory agencies such as the U.S. Food and Drug Administration (FDA) and Brazil's National Health Surveillance Agency (Anvisa). These agencies have their own unique sets of requirements for technical documentations. Navigating these  regulatory landscapes can be challenging, so we can see how a streamlined approach to managing product information can be crucial not only to avoid repetitive work but also to bring products to the market faster.

The consequences of that

When a change to the intended purpose is decided, the documentation can fast descend into chaos. Imagine the amount of pitfalls when modifying multiple documents across different regulatory regimes without a unified strategy. How many documents need to be modified when a change to the intended purpose is decided? How many documents are forgotten, resulting in different wordings of the same content over time? And how long will it take an auditor to stumble upon the first discrepancy?

And when we maintain a technical documentation of course the intended purpose is not the only redundant information - think about user groups, patient population, storage temperature, software settings... Each information with a unique set of documents to maintain and keep in mind.

Does it have to be this way?

Given these challenges, it's worth exploring whether there's a more efficient and effective way to manage product information, particularly the intended purpose. Imagine how much time and energy you could save if you no longer had to open and revise ten different documents just to update the wording for the intended purpose of one product. At meddevo, we believe it is time to change the way we manage product information.

meddevo tries to make a difference

This is where meddevo comes into play. We're on a mission to revolutionize the way we handle product information, putting an end to the déjà vu of repetitive document revisions. Our fundamental belief is that once information is defined, it should automatically populate all the relevant documents, both within and beyond the IVDR. No one should have to endure the time-consuming, repetitive task of updating multiple documents manually.

In the meddevo ecosystem, product information is centrally maintained and managed, transcending regulatory topics and document types. Our intelligent logic takes care of synchronization, updates, and compliance in the background. The result? A fast, stress-free regulatory process that enables you to focus on what truly matters – ensuring the safety and quality of our In Vitro Diagnostic (IVD) products.

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