Definitions and legal basis 1.1. Organigramme 1.2. Legal basis 1.3. Definitions 1.3.1. Materiovigilance 1.3.2. Medical Device 1.3.3. Corrective Action 1.3.4. Field Safety Corrective Action (FSCA) 1.3.5. Field Safety Notice (FSN) 2. What shall be notify?
1.2. Legal basis
1.3.2. Medical Device
1.3.3. Corrective Action
1.3.4. Field Safety Corrective Action (FSCA)
1.3.5. Field Safety Notice (FSN)
2. What shall be notify?
3. Who should be notify?
4. When must incidents be notified?
5. How should incidents be notified?
5.2. Manufacturers, distributors, authorised representativesMedical Device Vigilance
Medical Device Vigilance
Special Investigation Unit d’enquête
Marketing Authorisation Division
Variations & Renewals
Marketing Authorisation Division(human)
for Veterinary use
Health Products Division
Proper Use Division1. Definitions and legal basis
Royal decree 18/03/1999 (art. 11): Medical Device (MD)
Royal decree 15/07/1997 (art. 12): Active Implantable Medical Device (AIMD)
Directive 93/42/EEC (MD)
Directive 90/385/EEC (AIMD)
Guideline: MEDDEV 2.12-1 rev 6: not legally binding1. Definitions and legal basis
Medical device is defined as any instrument, equipment, material or other article used on its own or jointly, including software required for it to function correctly, which is intended by the manufacturer to be used on humans for the following purposes :
for diagnostic, prevention, control, treating or diminishing an illness
for diagnostic, control, treating, for diminishing or compensating an injury or handicap,
for studying, replacing or modifying part of the anatomy or a physiological process
for mastering conception
and whose principal intended action in or on the human body is not obtained by pharmacological or immunological means or by metabolism but whose function can be assisted in such a way.
More definition in the art. 1 of the law : accessory, active medical device, active implantable medical device, custommade device.1. Definitions and legal basis
Action to eliminate the cause of a potential non-conformity or other undesirable situation.
NOTE1: There can be more than one cause for non-conformity.
NOTE 2: Corrective action is taken to prevent recurrence whereas preventive action is taken to prevent occurrence.1. Definitions and legal basis
A FIELD SAFETY CORRECTIVE ACTION is an action taken by a MANUFACTURER to reduce a risk of death or serious deterioration in the state of health associated with the use of a MEDICAL DEVICE that is already placed on the market. Such actions should be notified via a FIELD SAFETY NOTICE.
The FSCA may include
- the return of a MEDICAL DEVICE to the supplier;
- device modification;
- device exchange;
- device destruction;
- retrofit by purchaser of MANUFACTURER's modification or design change;
- advice given by MANUFACTURER regarding the use of the device (e.g. where the
device is no longer on the market or has been withdrawn but could still possibly be in use)
A device modification can include:
- permanent or temporary changes to the labelling or instructions for use;
- software upgrades including those carried out by remote access;
- For implantable devices it is often clinically unjustifiable to explant the device.
Corrective action taking the form of special patient follow-up, irrespective of
whether any affected un-implanted devices remain available for return, constitutes
FSCA.1. Definitions and legal basis
- any technical or medical reason related to the characteristics or performance of a device for reasons shown in the previous paragraph and having led to the systematic withdrawal from the market by a manufacturer of devices of the same type.2.What shall be notify?
An incident is considered serious if it has one of the following consequences or could have had such a consequence:
- death, an illness or a handicap - a permanent lesion of a function or structure - the need for a medical or surgical operation - for a prolongation of a surgical operation - incorrect results of examinations leading to an
incorrect diagnostic or treatment2.What shall be notify?
1. An infusion pump stops, due to a malfunction, but gives an appropriate alarm (e.g. in compliance with relevant standards) and there was no injury to the patient. do not need to be reported.
2. An infusion pump stops, due to a malfunction of the pump, but fails to give an appropriate alarm; there is no patient injury. This should be reported as in a different situation it could have caused a serious deterioration in state of health.2.What shall be notify?
4. A defect is discovered in one (hitherto unopened) sample of a batch (lot) of a contact lens disinfecting agent that could lead to incidence of microbial keratitis in some patients. The MANUFACTURER institutes a FSCA of this batch. The FSCA should be reported.2.What shall be notify?
6. The premature revision of an orthopedic implant is required due to loosening. Although no cause is yet determined, this INCIDENT should be reported.2.What shall be notify?
Email address : email@example.com. Who should notify?
5.1 User (pharmacist, doctors)
Market surveillance and vigilance
2.12 Market surveillance (Manufacturer Incident Report and Field safety Corrective Action)5. How should incidents be notified?
5.2. Manufacturers, distributors, authorised representatives,…
- The traceability data for Belgium (list of Belgian Customers, with quantities provided per lot number).
- The model letter in our national languages (FSN)
- Once available evidence that the users have received the letter and reconciliation data.5. How should incidents be notified?