Do these products belong together?! Issues with Product Groups and Scope of Technical Documentation
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.
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;
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?
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."
From my experience, I advice manufacturers to consider the following activities:
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.