How medical device and IVD manufacturers identify regulatory dependencies, coordinate supporting evidence, and determine next steps across departments.
An article by Dr. Julia Bubeck, Head of Operations at Metecon.
The notified body is awaiting responses, new post-market data needs to be considered in the clinical evaluation or performance evaluation, and the development team is planning a product change. For those responsible for Regulatory Affairs, Clinical Affairs, and Quality Management, bringing these requirements together is part of everyday work. Each task matters, and behind each one are teams that depend on the outcome.
Deciding what to address first requires a clear understanding of the regulatory relationships involved. As long as key questions about product requirements, risks, or the adequacy of existing data remain unresolved, subsequent testing and evaluations may rely on assumptions that later need to be revised. At the same time, some activities can move forward more quickly when everyone involved works together to identify what is still needed.
Bringing together perspectives from the relevant departments early is particularly important. When Development, RA, Clinical Affairs, and QM approach their tasks primarily from their own perspectives, dependencies can easily go unnoticed. A question from Production or an observation from Clinical Affairs may change what evidence is needed and where work should begin. This is why the initial assessment should involve the relevant teams from the outset. The following five steps illustrate this approach using a planned product change as an example.
1. What regulatory question is behind the task?
The task “Update technical documentation” does not yet identify the underlying question: Required evidence may be missing, existing results may no longer cover the current device configuration, or statements about the intended purpose, risk management, and clinical evaluation may be inconsistent.
Before work begins, it is worth defining the issue together. If a test report is missing, for example, establish whether the test has yet to be performed or whether only the documentation is missing. If an acceptance limit is unclear, first establish and justify the criteria against which the results will be evaluated. Where information is inconsistent, determine which statement is correct and which other documents are affected. The same task description can lead to very different next steps.
Suppose the development team wants to replace a component. Everyone involved first needs a precise description of the change: Which material properties, specifications, or functions will change, which product variants are affected, and will the intended purpose and performance characteristics remain unchanged? This information provides the basis for assessing the impact and identifying the evidence needed for the modified device configuration.
Taking time for this initial discussion helps everyone work from a shared understanding of the question to be resolved.
2. What does the unresolved question mean for the product?
Priorities will differ depending on whether an issue concerns the conformity of a product already on the market, needs to be resolved before a planned change can proceed, or affects access to an additional market. The joint assessment should therefore consider both deadlines and the potential implications of the unresolved issue.
For a component change, the initial focus may be entirely on the modified configuration. If a review of the supporting evidence reveals that an existing assumption is not adequately substantiated, the team needs to examine whether this also affects the current configuration. That finding may change the priority of the assessment.
New findings about a potential safety issue require immediate assessment and, where necessary, appropriate action and escalation through established procedures. Binding deadlines and obligations must also be considered.
Making uncertainties explicit helps colleagues understand what is needed. “Impact on safety and performance not yet assessed” describes the need for action more clearly than “high priority.” It also helps others understand what they need to contribute and why their input is needed now.
3. What needs to be clarified before further evidence can be generated?
Product requirements help determine which tests are needed; the results may, in turn, require a reassessment of risks or updates to other evaluations. Understanding these dependencies helps teams identify where essential information is still missing and which activities can already begin.
For a component change, the change description provides the basis for assessing which risks are affected, whether existing measures remain appropriate, and what verification or validation is needed. A material change may raise questions about biological safety, while changes to performance characteristics may affect the clinical evaluation. For IVDs, the corresponding implications for the performance evaluation need to be assessed.
Consider a possible test-planning scenario: A test slot is available at the laboratory, and the team wants to use it, but the acceptance criteria for the modified component have not yet been established. Before testing begins, the team needs to clarify what the test is intended to demonstrate and whether the test setup and acceptance criteria are suitable for that purpose.
Meanwhile, existing reports can be reviewed and the affected product variants cross-checked. There is no need to put everything on hold simply because one important question remains unresolved.
The guiding question is: What do we need to clarify first to substantiate the required statements about the product’s safety and performance?
4. Bringing perspectives together: How do the assessments fit together?
When a product changes, each department may complete its own work carefully while important questions between teams remain unresolved. Development describes the technical change, Clinical Affairs reviews the underlying evidence, QM examines the affected processes, and RA assesses the regulatory implications. If these activities rely on different assumptions, the inconsistencies may only become apparent late in the process.
Cross-functional collaboration starts with addressing the key questions together early: What is changing about the product? What implications does each department see? And how does one team’s assessment affect the work of the others? This requires discussion of assumptions, prerequisites, and uncertainties before they inform test plans and assessments.
| Department | Contribution to assessing a product change |
|---|---|
| Development | Describe the change, affected requirements, and technical evidence. |
| Risk Management and QA/QM | Assess the impact on risks, measures, and affected processes, including production. |
| Clinical Affairs | Assess whether clinical evidence or performance data covers the modified device configuration. |
| Regulatory Affairs | Assess the impact on documentation and the regulatory pathway for the affected products and markets. |
Who contributes to each activity depends on your organization’s processes. What matters is that everyone bases their assessment on the same device configuration and discusses the assumptions they are using.
If Development considers a component change technically minor while Clinical Affairs questions whether existing data remains applicable, the two assessments are not necessarily contradictory. The teams may be considering different aspects of the change. Production may also point out that the component will need to be processed differently, requiring an assessment of the impact on manufacturing.
A useful question at this stage is: “What exactly is changing from your perspective, and what conclusions do you draw from that?” This creates room for concerns that may not have been apparent in the original change description.
Then check whether the test reports and clinical evaluation cover the device configuration addressed in risk management and whether their conclusions are consistent.
5. What decision does this enable?
Following the joint assessment, the team should understand what evidence is required, which regulatory steps still need clarification, and which prerequisites must be met before implementation. RA considers the conformity or regulatory approval status and the affected markets; whether and how the notified body needs to be involved must be assessed in the relevant context.
Senior management can make a more informed decision when the available options are presented alongside the unresolved issues. Is the existing evidence sufficient for the modified configuration? What additional evidence is needed? What would be the consequences of adjusting the scope of the change or postponing it?
“We need more capacity” leaves these questions unanswered. A more useful explanation identifies the assessment or evidence needed, the expertise required, and the decision that depends on the outcome.
The roadmap brings these considerations together and sets out the sequence of clarification, testing, and assessment activities. New findings may change that sequence, so agree on which results or unresolved questions should prompt the team to reconvene and review the next steps.
Start with a specific project
Choose a project where progress has stalled and work through a shared overview with the colleagues involved, using the following columns:
- Unresolved regulatory question
- Affected product / project
- Departments and individuals to involve
- Implications for safety, performance, and conformity
- Clarification or evidence needed
- Dependent assessments
- Decision required
Use this overview as the basis for a discussion in which everyone explains and compares their assessments. An issue that seems settled in one department may still raise questions from another perspective. Exploring these differences helps identify where an assumption needs to be checked, further evidence is needed, or a decision needs input from several teams.
Not every question will be answered in the first discussion. What matters is that everyone understands how their work connects with the contributions of others, what has already been resolved, and what is needed next. This gives the team a shared rationale for the sequence of activities and a basis for moving forward together.
To learn how manufacturers can establish this collaboration as a lasting part of their organization and prepare for change, visit our page on regulatory resilience.
Would you like to clarify regulatory priorities for your products and projects? In a free, no-obligation initial consultation, we will discuss your situation and explore where clarification is needed and how Metecon can support you.
