How to group your products under MDR & IVDR

Do these products belong together?! Issues with Product Groups and Scope of Technical Documentation

Introduction

The Medical Device Regulation (MDR) and the In Vitro Diagnostics Regulation (IVDR) demands a substantial amount of action taken on our products: we perform risk analysis, implement risk control measures, go into usability studies, perform clinical evaluation, evaluate the need for biocompatibility tests and define post-market surveillance activities. When a manufacturer's product catalogue is vast and many products bear resemblance, creating distinct documents for each of those activities for each product can turn into a monotonous and overwhelming task. Luckily, the MDR and IVDR allows us to group products together. One technical documentation can cover multiple similar products, and processes can also be performed on groups of products.

At first glance, this sorting of individual products into product groups might appear straightforward. However, upon deeper inspection, many complications associated with inconvenient grouping emerge. Let's delve into this matter more thoroughly.

Grouping of products

The grouping of products hinges primarily on their shared aspects, such as the technology they use, their functionality, or their application. More specifically, the MDR / IVDR defines:

‘generic device group’ means a set of devices having the same or similar intended purposes or a commonality of technology allowing them to be classified in a generic manner not reflecting specific characteristics;

The Ambiguities of Grouping

At face value, the definition of 'generic device group' may appear clear-cut, but once we begin to dissect it, certain ambiguities become apparent. What constitutes a "same or similar intended purpose"? What does it mean to classify devices "in a generic manner"?

The term "same or similar intended purpose" implies that devices are designed to achieve the same goal or goals that are closely related. However, the ambiguity lies in defining how similar the purposes need to be to justify the same group classification. Is it enough that two devices monitor vital signs, or should they both specifically monitor, for example, blood pressure? The interpretation can significantly affect how product groups are constituted.

Similarly, the phrase "classified in a generic manner" is open to interpretation. It could imply a focus on the overarching function or technology rather than minute details. But how broad or narrow should this focus be? Do minor variations in technology or design necessitate separate groups, or can they be overlooked in favor of a more 'generic' approach?

Complexity in product grouping

The complexity in product grouping becomes evident in the required processes of compliance.

Every grouping strategy will have its pros and cons, influenced by the specific attributes and uses of the products involved. For example, a grouping based on common product materials might simplify biocompatibility and material durability testing, but it may encompass products with different user needs or risk profiles, thus creating difficulties in handling these products in one usability file.

Surprisingly, you can take the Basic-UDI-DI as a guideline. MDCG 2018-1 tells us that you can connect several products under one Basic-UDI-DI. Doesn't that sound like a product group?! We have explicit explanations for what can be summarized in one Basic-UDI-DI. This is: "...devices with the same intended purpose, risk class, and essential design and manufacturing characteristics."

Follow these activities

From my experience, I advice manufacturers to consider the following activities:

1. Identifying Meaningful Similarities: To form effective product groups, manufacturers must identify meaningful similarities among devices. This involves assessing various aspects, such as intended purpose, technology, functionality, and application. It's important to strike the right balance between similarity and specificity. While overly broad groupings might overlook critical differences, excessively narrow classifications can lead to an unnecessarily fragmented Technical Documentation. In the case of monitoring devices, for instance, the manufacturer should determine whether differences in monitored parameters warrant separate groupings or can be addressed within a generic framework.
2. Acknowledging Significant Differences: Conversely, recognizing and addressing significant differences among products is equally essential. These differences might have implications on various processes, such as risk analysis, usability studies, and clinical evaluations. For example, if one product in a group involves radiation exposure while others do not, a dedicated risk assessment specifically addressing radiation-related concerns becomes necessary. Similarly, varying user groups might require distinct usability assessments.
3. Match via the Basic UDI-DI: You can check the information Eudamed asks for each Basic UDI-DI entry. Your product groups should be similar on all those points.
4. Ensuring Coherence and Traceability: Throughout the TD, it's crucial to maintain a clear and logical narrative that demonstrates how the grouping decisions were made. While it is may seem obvious for you, many reviewers are left clueless on why products are grouped. Therefor, traceability is vital for regulatory review and helping your auditor understand your technical documentation promptly. Explain early on in your technical documentation why certain products were grouped together, how their similarities and differences were accounted for, and how the chosen approach aligns with the MDR's requirements.
   

Sometimes opening up this seemingly easy topic can uncover many uncertainties and feel tedious. But please don`t run into the error if ignoring or postponing it - changes to those fundamental decisions later on can result in a tremendous amount of additional work. This is especially true when the Technical Documentation and MDR/IVDR processes are managed in Word, Excel format and folders. Invest sufficient time on these strategic decisions in the beginning and save yourself a lot of trouble later on! Consider designing your product groups right away in a digital environment. Here, major changes are possible with much less effort.

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