Adverse event

Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs, including an abnormal laboratory finding, in subjects, users or other persons, in the context of a clinical investigation, whether or not related to the investigational device. Under the IVDR: any untoward medical occurrence, inappropriate patient management decision, unintended disease or injury or any untoward clinical signs, including an abnormal laboratory finding, in subjects, users or other persons, in the context of a performance study, whether or not related to the device for performance study.

Reference: MDR Article 2(57); IVDR Article 2(60)

Corrective action

Action taken to eliminate the cause of a potential or actual non-conformity or other undesirable situation.

Reference: MDR Article 2(67); IVDR Article 2(70)

Device deficiency

Any inadequacy in the identity, quality, durability, reliability, safety or performance of an investigational device, including malfunction, use errors or inadequacy in information supplied by the manufacturer. Under the IVDR: any inadequacy in the identity, quality, durability, reliability, safety or performance of a device for performance study, including malfunction, use errors or inadequacy in information supplied by the manufacturer.

Reference: MDR Article 2(59); IVDR Article 2(62)

Field safety corrective action

Corrective action taken by a manufacturer for technical or medical reasons to prevent or reduce the risk of a serious incident in relation to a device made available on the market.

Reference: MDR Article 2(68); IVDR Article 2(71)

Field safety notice

A communication sent by a manufacturer to users or customers in relation to a field safety corrective action.

Reference: MDR Article 2(69); IVDR Article 2(72)

Incident

Any malfunction or deterioration in the characteristics or performance of a device made available on the market, including use-error due to ergonomic features, as well as any inadequacy in the information supplied by the manufacturer and any undesirable side-effect. Under the IVDR: any malfunction or deterioration in the characteristics or performance of a device made available on the market, including use-error due to ergonomic features, as well as any inadequacy in the information supplied by the manufacturer and any harm as a consequence of a medical decision, action taken or not taken on the basis of information or result(s) provided by the device.

Reference: MDR Article 2(64); IVDR Article 2(67)

MIR — Manufacturer incident report

The standard form used to report a serious incident to a competent authority under the vigilance system. The form and its coding are set out in Commission guidance rather than in the regulation itself, which specifies the reporting deadlines and the content required.

Reference: MDR Article 87; IVDR Article 82

Recall

Any measure aimed at achieving the return of a device that has already been made available to the end user.

Reference: MDR Article 2(62); IVDR Article 2(65)

Serious incident

Any incident that directly or indirectly led, might have led or might lead to any of the following: (a) the death of a patient, user or other person, (b) the temporary or permanent serious deterioration of a patient's, user's or other person's state of health, (c) a serious public health threat. Under the IVDR: any incident that directly or indirectly led, might have led or might lead to any of the following: (a) the death of a patient, user or other person, (b) the temporary or permanent serious deterioration of a patient's, user's or other person's state of health, (c) a serious public health threat; 02017R0746 — EN — 10.01.2025 — 005.001 — 11.

Reference: MDR Article 2(65); IVDR Article 2(68)

Serious adverse event

Any adverse event that led to any of the following: (a) death, (b) serious deterioration in the health of the subject, that resulted in any of the following: (i) life-threatening illness or injury, (ii) permanent impairment of a body structure or a body function, (iii) hospitalisation or prolongation of patient hospitalisation, (iv) medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function, (v) chronic disease, (c) foetal distress, foetal death or a congenital physical or mental impairment or birth defect. Under the IVDR: any adverse event that led to any of the following: (a) a patient management decision resulting in death or an imminent life-threatening situation for the individual being tested, or in the death of the individual's offspring, (b) death, (c) serious deterioration in the health of the individual being tested or the recipient of tested donations or materials, that resulted in any of the following: (i) life-threatening illness or injury, (ii) permanent impairment of a body structure or a body function, (iii) hospitalisation or prolongation of patient hospitalisation, 02017R0746 — EN — 10.01.2025 — 005.001 — 10 (iv) medical or surgical intervention to prevent life- threatening illness or injury or permanent impairment to a body structure or a body function, (v) chronic disease, (d) foetal distress, foetal death or a congenital physical or mental impairment or birth defect.

Reference: MDR Article 2(58); IVDR Article 2(61)

Serious public health threat

An event which could result in imminent risk of death, serious deterioration in a person's state of health, or serious illness, that may require prompt remedial action, and that may cause significant morbidity or mortality in humans, or that is unusual or unexpected for the given place and time.

Reference: MDR Article 2(66); IVDR Article 2(69)

Trend reporting

The obligation to report any statistically significant increase in the frequency or severity of incidents that are not themselves serious, or of expected undesirable side-effects, where that increase could materially affect the benefit-risk determination.

Reference: MDR Article 88; IVDR Article 83

Vigilance — Vigilance reporting

The reporting of serious incidents and field safety corrective actions to competent authorities within prescribed deadlines, followed by investigation and, where needed, corrective action. Distinct from post-market surveillance, which is the wider ongoing data-gathering activity.

Reference: MDR Article 87; IVDR Article 82

Withdrawal

Any measure aimed at preventing a device in the supply chain from being further made available on the market.

Reference: MDR Article 2(63); IVDR Article 2(66)