Serious errors in the Ministry guidelines on vigilance

Reading the Ministry of Health document “Guidelines for reporting complaints about medical devices” issued with the Circular of June 6, 2023 (prot. 47854), raises multiple concerns.

Comparing this text with the pillars of regulation – Regulation (EU) 2017/745 (MDR), the ISO 13485 standard and the MDCG guidelines – logical inconsistencies and excessive simplifications emerge that, if followed to the letter, could expose healthcare operators and manufacturers to serious compliance errors.

The false dichotomy between complaint and incident

The main formal flaw of the ministry document lies in the attempt to create a clear and mutually exclusive dichotomy between Complaint and Incident.

The document cites the definition of complaint from the ISO 13485:2016 standard, correctly defining it as a communication declaring deficiencies related to identity, quality, safety or performance. However, in the continuation, the text suggests that if an event is a complaint, then it is not an incident, and vice versa.

This deduction is nonsensical in light of the regulation, where complaint management is the container process (the input) from which the investigation must arise to determine whether the event should be reported to competent authorities (therefore whether it is an incident or a serious incident). In other words: a serious incident almost always originates as a complaint, but in the ministry document the two concepts are treated as distinct outcomes of a classification, rather than consequential phases of a process.

The incorrect flowchart

The most critical and confusing element of the document is the flowchart presented on page 7.

The initial question: the flow asks whether the event meets the incident criteria (art. 2 n. 64/67 MDR/IVDR).

• If YES -> “It is an Incident”.
• If NO -> It proceeds to evaluate patient involvement and if there was no involvement of people or health consequences, the flow inexorably leads to the outcome: “IT IS A COMPLAINT”.

Here lies the fundamental practical error: the diagram considers the Complaint block as a standalone element, an endpoint. It does not provide any flow line that, after the complaint classification, brings the event back into the risk analysis or incident block.

Why this scheme is wrong

According to the MDR (Art. 2 point 64), an incident includes “any malfunction or deterioration of characteristics or performance”. Actual harm is not required to define an event as an “incident”; harm is discriminating for a serious incident (Art. 2 point 65).

The ministry diagram, instead, clearly indicates that a malfunction detected before use on the patient (e.g., “Discovery of a foreign body inside the packaging before its use”) should be simply filed as a Complaint.

This approach ignores two fundamental manufacturer obligations established by the MDR and reiterated by the MDCG guidelines:

1. Trend Reporting (Art. 88 MDR): manufacturers must report significant increases in non-serious incidents. If the operator or manufacturer follows the ministry flowchart and classifies these events as simple complaints (standalone elements), these could escape statistical analysis for trend reporting, violating Article 88.
2. Risk potential: the MDCG 2023-3 Rev.2 guideline clarifies that even if an incident has not caused harm, the manufacturer must evaluate whether it could have caused it under less favorable circumstances. The ministry flowchart cuts short: no harm, no incident, “It is a Complaint”. End.

The MDCG 2023-3 guide presents a very different decision tree: it starts from receiving “vigilance information (e.g., a complaint)” and evaluates whether it meets incident criteria. There is no “Complaint” outcome that exempts from further trend or risk evaluations; there is only the distinction between what must be reported immediately (serious incident) and what must be monitored (non-serious incident/adverse effect).

The incongruent examples

Given the above and keeping in mind that for the ministry document the complaint is an endpoint that does not lead to further classifications, the Ministry provides examples of events “classified as complaints” (which is intrinsically already incorrect) that, from a risk management and MDR compliance perspective, are extremely problematic.

Contested example 1: “Upon extraction of the coronary stent from the package, complete decrimping between the stent and the balloon that houses it is evident, therefore the device is unusable” is classified as a Complaint.
Critical analysis: a stent detachment is a critical malfunction. If this happens while the device is on the operating table, it causes a delay in the procedure (need to get another one) or, if not seen, a risk to the patient. Classifying it as a mere complaint (equating it to “missing a component in the box”) underestimates the clinical risk. According to MDR Art. 2(64), any “malfunction” is an incident.

Contested example 2: “Cracking of a catheter identified before use on the patient” classified as a Complaint.
Critical analysis: a breach of device integrity (durability/reliability) is an incident according to the MDR definition. The fact that it was detected before use is a fortunate circumstance. If that batch of catheters has a manufacturing defect, the next one might break when in use on a patient.

The hierarchy of sources

The “Guidelines” document on vigilance published by the Ministry, although born with the intent to simplify, risks trivializing complex processes by introducing operational definitions that find no correspondence in the European legal text.

To prevent superficial documents from leading to compliance errors, industry professionals must:

1. Respect the hierarchy of sources: Regulation (EU) 2017/745 and MDCG guidelines (e.g., MDCG 2023-3) have interpretative precedence over any national circular or guideline.
2. Reconsider the complaint: not see it as a final label, but as the beginning of an investigation. Every complaint must be evaluated not only for the harm that occurred, but for the potential for harm and for compliance with specifications.
3. Ignore “dead ends”: if using a decision flowchart, ensure that every outcome (even “non-serious”) flows into the trend monitoring and risk analysis system, as required by ISO 13485 and the MDR.

The correct identification and classification of adverse events is fundamental to ensuring patient safety, maintaining compliance with applicable regulation and minimizing legal risks for the manufacturer.

Understanding the difference between complaints, incidents and serious incidents is a key step in effective vigilance management. It is fundamental to understand that a complaint is not an event in itself, but the means through which an event is reported: it is the way, the tone, the tool.

Identifying a report as a complaint does not exclude that it may refer to an incident; likewise and obviously, the fact that an event is classified as an incident does not exclude that it may be qualified as a serious incident.