What needs to be done when a manufacturer becomes aware of an INCIDENT with a medical device?
(18 June 2009)
1. Member States shall take the necessary steps to ensure that any information brought to their knowledge, in accordance with the provisions of this Directive, regarding the incidents mentioned below involving devices bearing the CE marking is recorded and evaluated centrally:
(a) any malfunction, failure or deterioration in the characteristics and/or performance of a device, as well as any inadequacy in the labelling 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;
(b) any technical or medical reason in relation to the characteristics or performance of a device for the reasons referred to in subparagraph (a), leading to systematic recall of devices of the same type by the manufacturer.
2. Where a Member State requires medical practitioners, the medical institutions or the organisers of external quality assessment schemes 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, Member States shall, without prejudice to Article 8, immediately inform the Commission and the other Member States of the incidents referred to in paragraph 1 for which appropriate measures, including possible withdrawal, have been taken or are contemplated.
4. Where, in the context of notification referred to in Article 10, a device notified, bearing the CE marking, is a ‘new’ product, the manufacturer shall indicate this fact on his notification. The competent authority so notified may at any time within the following two years and on justified grounds, require the manufacturer to submit a report relating to the experience gained with the device subsequent to its being placed on the market.
5. Member States shall on request inform the other Member States of the details referred to in paragraphs 1 to 4. The procedures implementing this Article shall be adopted in accordance with the regulatory procedure referred to in Article 7(2).
MEDDEV 2.12-1 rev 8: GUIDELINES ON A MEDICAL DEVICES VIGILANCE SYSTEM
EUROPEAN COMMISSION DG ENTERPRISE AND INDUSTRY
Physical injury or damage to the health of people, or damage to property or the environment.
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.
4.11 INDIRECT HARM
In the majority of cases, diagnostic devices IVDs and IVF/ART medical devices will, due to their intended use, not directly lead to physical injury or damage to health of people (HARM – see section 4.8). These devices are more likely to lead to indirect harm rather than to direct harm. HARM may occur as a consequence of the medical decision, action taken/not taken on the basis of information or result(s) provided by the device or as a consequence of the treatment of cells (e.g. gametes and embryos in the case of IVF/ART devices) or organs outside of the human body that will later be transferred to a patient.
Examples of indirect harm include
- delayed diagnosis,
- delayed treatment,
- inappropriate treatment,
- absence of treatment
- transfusion of inappropriate materials.
Indirect harm may be caused by
- imprecise results
- inadequate quality controls
- inadequate calibration
- false positive or
- false negative results.
For self-testing devices, a medical decision may be made by the USER of the device who is also the patient.
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.