What needs to be done when a manufacturer becomes aware of an INCIDENT with a medical device?
Council Directive 90/385/EEC
(5 September 2007)
1. Member States shall take the necessary steps to ensure that information brought to their knowledge regarding the incidents mentioned below involving a device is recorded and evaluated in a centralised manner:
(a) any malfunction of or deterioration in the characteristics and performances of a device, as well as any inadequacy in the labelling or in the instructions for use which might lead to or might have led to the death of a patient or user or to a serious deterioration in his state of health;
(b) any technical or medical reason in relation to the characteristics or performances of a device for the reasons referred to in point (a), leading to systematic recall of devices of the same type by the manufacturer.
2. Where a Member State requires medical practitioners or the medical institutions to inform the competent authorities of any incidents referred to in paragraph 1, it shall take the necessary steps to ensure that the manufacturer of the device concerned, or his authorised representative, is also informed of the incident.
3. After carrying out an assessment, if possible together with the manufacturer or his authorised representative, Member States shall, without prejudice to Article 7, immediately inform the Commission and the other Member States of measures that have been taken or are contemplated to minimise the recurrence of the incidents referred to in paragraph 1, including information on the underlying incidents.
4. The measures necessary for the implementation of this Article shall be adopted in accordance with the regulatory procedure referred to in Article 6(3).
MEDDEV 2.12-1 rev 8: GUIDELINES ON A MEDICAL DEVICES VIGILANCE SYSTEM
EUROPEAN COMMISSION DG ENTERPRISE AND INDUSTRY
“Any malfunction or deterioration in the characteristics and/or performance of a device, as well as any inadequacy in the labeling or the instructions for use which, directly or indirectly, might lead to or might have led to the death of a patient, or USER or of other persons or to a serious deterioration in their state of health.”
5.1.1 CRITERIA FOR INCIDENTs TO BE REPORTED BY MANUFACTURERS TO COMPETENT AUTHORITIES
Any event which meets all three basic reporting criteria A – C listed below is considered as an INCIDENT and must be reported to the relevant National Competent Authority. The criteria are that:
A: An event has occurred
This also includes situations where testing performed on the device, examination of the
information supplied with the device or any scientific information indicates some factor that
could lead or has led to an event.
Typical events include, but are not limited to:
a) A malfunction or deterioration in the characteristics or performance. A malfunction or deterioration should be understood as a failure of a device to perform in accordance with its INTENDED PURPOSE when used in accordance with the MANUFACTURER’s instructions.
b) For IVDs where there is a risk that an erroneous result would either (1) lead to a patient management decision resulting in an imminent life-threatening situation to the individual being tested, or to the individual’s offspring, or (2) cause death or severe disability to the individual or fetus being tested, or to the individual’s offspring, all false positive or false negative test results shall be considered as events. For all other IVDs, false positive or false negative results falling outside the declared performance of the test shall be considered as events.
c) Unanticipated adverse reaction or unanticipated side effect
d) Interactions with other substances or products
e) Degradation/destruction of the device (e.g. fire)
f) Inappropriate therapy
g) An inaccuracy in the labelling, instructions for use and/or promotional materials. Inaccuracies include omissions and deficiencies. Omissions do not include the absence of information that should generally be known by the intended USERs.
B: The MANUFACTURER’s device is suspected to be a contributory cause of the INCIDENT
In assessing the link between the device and the INCIDENT the MANUFACTURER should take account of:
- the opinion, based on available evidence, of healthcare professionals;
- the results of the MANUFACTURER’s own preliminary assessment of the INCIDENT;
- evidence of previous, similar INCIDENTs;
- other evidence held by the MANUFACTURER.
This judgement may be difficult when there are multiple devices and drugs involved. In complex situations, it should be assumed that the device may have caused or contributed to the INCIDENT and the MANUFACTURERs should err on the side of caution.
C: The event led, or might have led, to one of the following outcomes:
- death of a patient, USER or other person
- serious deterioration in state of health of a patient, USER or other person.
A serious deterioration in state of health can include (non exhaustive list):
a) life-threatening illness,
b) permanent impairment of a body function or permanent damage to a body structure,
c) a condition necessitating medical or surgical intervention to prevent a) or b).
Examples: – clinically relevant increase in the duration of a surgical procedure,
– a condition that requires hospitalisation or significant prolongation of existing hospitalisation.
d) any indirect harm (see definition under section 4.11) as a consequence of an incorrect diagnostic or IVD test result or as a consequence of the use of an IVF/ART device when used within MANUFACTURER´s instructions for use (use errors reportable under section 188.8.131.52 must also be considered).
e) foetal distress, foetal death or any congenital abnormality or birth defects.