Structuring Your Product Portfolio in meddevo
To unlock the full benefits of meddevo, the most important decision is WHICH information should be organized on WHICH level within meddevo. The chosen structure has a significant impact on how easily you can maintain, reuse, and generate the necessary documents in the future.
1. Understand the Hierarchical Levels in meddevo
meddevo operates with a three-tier hierarchy:
- Technical Documentation (eTD): The highest level, grouping together product groups for which a shared certificate is pursued.
- Product Group (PG): For product families or groups whose features are very similar or managed collectively.
- Product (P): For individual sales products.
→ It is, of course, possible to use only two levels—or even a single level—if that makes more sense for your product portfolio.
Why This Hierarchy?
- The more general the information, the higher up in the hierarchy it should be stored. For example, if many products in a product group share the same user group, you only need to maintain this information once at the product group level, rather than repeatedly for each individual product.
- The more specific the information, the lower in the hierarchy it should be maintained.
2. Strategy: “As high as possible – as low as necessary!”
The guiding principle when planning your structure: Always keep information at the highest level where it remains accurate and valid. This approach reduces unnecessary duplication and allows for more efficient centralized updates. At the same time, it helps prevent overloading individual products with irrelevant information.
Practical tip: Consider whether a piece of information will be exactly the same for all current and future products or groups—if so, store it as high up as possible!
3. Should You Use or Adapt the meddevo Standard Structure?
meddevo offers a predefined standard structure closely aligned with regulatory requirements and industry best practices. It is recommended to follow this structure unless you have compelling reasons to adapt it. This brings several advantages:
- meddevo templates are designed with this structure in mind.
- Migrations, updates, and support are simplified.
- The system remains understandable for new team members.
Only adapt the structure where necessary to accommodate truly unique aspects of your products or processes.
To provide you with an overview of the data and form fields available in meddevo, and the levels at which they are maintained, you will find an Excel spreadsheet below for both MDR and IVDR.