Undefined: Practical Guidance for Manufacturers, Authorised Representatives and Responsible Persons

Ambiguity is a fact of regulatory life. Terms can be undefined, requirements can seem open to interpretation, and guidance may lag behind innovation. For manufacturers, authorised representatives, and the responsible persons who keep compliance moving, undefined moments are not a reason to pause—they’re a cue to put robust, proactive systems in place. This post offers practical, field-tested guidance to navigate undefined or unclear regulatory terrain with clarity and control.

Introduction: turning ambiguity into a workable process

Regulatory frameworks are designed to protect public safety, ensure quality, and foster market confidence. Yet they rarely spell out every scenario in absolute terms. Undefined or ambiguous provisions can arise from evolving technology, new product classifications, or evolving national implementations of broader EU rules. The key is not to wait for perfect clarity but to build governance that can interpret, document, and act when the path isn’t immediately obvious.

The aim is to create repeatable decision-making, transparent communication, and auditable records so that when a requirement is undefined, your organisation can move forward with confidence rather than hesitation. Below are role-specific guidance strands to help you do just that.

Guidance for manufacturers

1) Establish a clear governance framework
– Appoint a regulatory affairs lead and define decision rights across product lifecycle stages (concept, development, pre-market, post-market).
– Create a cross-functional regulatory task force including QA, clinical/technical evidence, safety, supply chain, and operations.
– Maintain an up-to-date regulatory roadmap that identifies areas where guidance exists, where it is unclear, and where it is evolving.

2) Develop a robust interpretation process for undefined requirements
– Create a formal “interpretation log” for ambiguous provisions. Document the interpretation you apply, the rationale, and the sources consulted.
– Use a decision protocol (e.g., risk-based triage) to decide whether to proceed, pause, or seek clarification.
– When possible, triangulate with multiple reputable sources: regulatory guidance papers, official notifications from authorities, and feedback from notified bodies or competent authorities.

3) Strengthen documentation and evidence plans
– Build a living technical documentation package that can be adapted as interpretations firm up.
– Maintain formal risk management files that explicitly address uncertainties and the controls you’ve chosen to mitigate them.
– Implement a robust post-market surveillance (PMS) plan that captures real-world performance and any regulatory questions that arise after launch.

4) Implement clear change control and versioning
– When a regulation is undefined or updated, ensure every change is reasoned, approved, and traceable.
– Establish a parallel change log for regulatory interpretations, not just product design changes.
– Communicate changes to all stakeholders (production, supply chain, marketing) to keep the entire chain aligned.

5) Foster external engagement and proactive clarification
– Build a relationship with regulatory bodies, industry groups, and notified bodies where relevant.
– When in doubt, draft a concise clarification request or cover letter that outlines the ambiguity, the proposed interpretation, and supporting rationale. Seek written guidance where possible.
– Document all exchanges and keep them readily auditable for audits or inspections.

6) Train and empower teams
– Deliver targeted training on how to handle undefined requirements, including how to use the interpretation log and decision protocols.
– Create quick-reference guides for frontline teams that explain what to do if a requirement is unclear during design, manufacturing, or quality events.

Guidance for authorised representatives

1) Define your role with clarity and guardrails
– Your responsibilities typically include ensuring the manufacturer’s conformity with applicable regulations, maintaining documentation, and acting as a liaison with regulators.
– Establish precise service level agreements (SLAs) with manufacturers regarding responses to regulatory questions, including undefined aspects.

2) Maintain up-to-date oversight of technical documentation
– Require the manufacturer to provide complete, traceable documentation that supports regulatory claims.
– Ensure that any interpretive judgments about undefined requirements are captured in a formal record, with sources cited and rationales explained.

3) Manage communications with authorities
– When a requirement is undefined, push for written guidance from the competent authority or notified body. Do not rely on informal advice.
– Keep a central log of all regulatory clarifications obtained, including the date, source, and the decision impact.

4) Enforce transparency in supply chain and compliance
– Verify supplier and sub-contractor compliance through audits or attestations, paying particular attention to areas where regulatory expectations are still evolving.
– Ensure changes in the manufacturer’s processes or interpretations are reflected in the conformity assessment documentation and in the authorised representative’s records.

5) Risk-based approach to non-clarity
– Where ambiguity exists, prioritise regulatory questions that pose the greatest risk to patient safety or to market access.
– Coordinate with the manufacturer to implement interim controls, such as heightened testing, extended PMS, or additional verifications, until guidance becomes more definite.

6) Training and governance
– Train your team in interpreting and challenging undefined requirements, including when to escalate to higher authorities.
– Maintain a governance log for decisions made in the face of ambiguity, including rationale and anticipated regulatory trajectory.

Guidance for responsible persons

1) Fulfil your statutory role with rigorous evidence
– The responsible person (or PRRC in EU MDR context) must ensure compliance with essential regulatory requirements. When rules are undefined, you must implement processes that do not rely on perfect clarity.
– Ensure the organisation can demonstrate ongoing compliance through documented processes, not just assumptions.

2) Verify and challenge interpretations
– Review the interpretations of undefined requirements proposed by manufacturers or authorised representatives. Challenge them where there are gaps or potential misalignment with the broader regulatory framework.
– Require explicit justification and traceability for any interpretation used to bring a device to market or to maintain it on the market.

3) Maintain a dynamic regulatory compliance plan
– Create and maintain a living plan that maps regulatory expectations, known ambiguities, planned clarifications, and deadlines for resolution.
– Align PMS and post-market vigilance activities with evolving interpretations to detect non-conformities or unintended consequences early.

4) Oversee change management and training
– Approve changes to regulatory interpretation workflows, QMS procedures, and technical documentation that arise from undefined requirements becoming clearer.
– Ensure ongoing training for cross-functional teams, with emphasis on how to handle evolving guidance and the importance of timely escalation when further clarification is needed.

5) Audit readiness and continuous improvement
– Build internal audits that specifically probe how undefined requirements are handled, whether decisions are properly recorded, and whether communications with regulators are complete and accurate.
– Use findings to refine governance, risk controls, and the interpretation process to reduce relapse into ambiguity.

Practical steps you can implement today

– Create an ambiguity log: a living document that records undefined requirements, the chosen interpretation, sources, rationale, and the plan for follow-up as guidance clarifies.
– Establish a rapid clarification channel: designate a point of contact who can request written guidance from regulators and coordinate responses across functions.
– Run a quarterly ambiguity review: gather the regulatory affairs team, QA, and operations to review new ambiguities, assess risk, and update the interpretation log.
– Develop standard templates: for clarification requests, decision rationales, and change control records, ensuring consistency and auditability.
– Prioritise PM and PMS alignment: if a requirement is unclear, escalate and ensure surveillance and post-market data collection remains robust and transparent.
– Build a culture of transparency: encourage teams to flag ambiguities early and document reasoning rather than allowing assumptions to propagate.

A note on scope and caution

This blog offers practical, field-tested guidance for navigating undefined regulatory requirements. It is informational and non-legal. Regulations vary by jurisdiction, and interpretations can evolve. Always consult your regulatory affairs professionals or legal counsel for advice tailored to your specific products, markets, and regulatory context.

Conclusion: turning undefined into a controlled, proactive process

Undefined regulatory territory can feel unsettling, but it also offers an opportunity to strengthen governance, documentation, and cross-functional collaboration. By building clear processes for interpretation, formalising escalation paths, and maintaining auditable records, manufacturers, authorised representatives, and responsible persons can move forward decisively—without compromising compliance or patient safety.

If you’d like, I can tailor this draft further to a specific jurisdiction (for example, EU MDR, UK MDR, or another regulatory framework), or adjust the tone to be more concise for a quick-read blog post.

February 03, 2026 at 11:14AM
法规：户外设备的噪声排放
为制造商、授权代表和负责人员提供的指南。

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