Introduction
Vigilance reporting is one of the pillars of post-market surveillance process for medical device. It belongs to the so-called “passive” methods of post-market surveillance activities, as basically the manufacturer does not perform any specific actions unless it becomes aware of a specific event which needs to be communicated to a National Competent Authority.
Obviously, the vigilance reporting process is highly linked to the process of compliant handling; having a strong system for the management of customer complaints is surely helpful to properly fulfil the requirements associated to vigilance reporting systems and, in general, post-market surveillance.
The European Medical Device Regulations introduced many new requirements in the field of post market surveillance (and related processes). We are talking, for example, of the so-called SSCP (Summary of Safety and Clinical Performance) or the new obligations related to the Post-Market Clinical Follow-up . Moreover, due to Brexit, the CE marking will not be suitable anymore for United Kingdom, introducing a new level of complexity in product-related certification.
There are not many changes on the vigilance reporting requirements with the introduction of the new European Medical Device Regulation and In-Vitro Diagnostic Device Regulation; however, there are few new concepts that need to be discussed.
In 2019, a new guideline entitled “Additional Guidance Regarding the Vigilance System as outlined in MEDDEV 2.12-1 rev. 8” has been published by the European Commission. This guideline introduced an updated Manufacturer’s Incident Report (MIR) form which became mandatory from January 2020. This form is universally applicable for all Incident/Serious Incident reporting under the AIMDD, MDD, and IVD Directives and the new EU MDR and EU IVDR Regulations.
Vigilance Reporting Requirements
Before starting the discussion on the requirements for vigilance reporting according to the European Medical Device Regulation, we shall clarify that it an event involving a medical device is considered “reportable” if it meets the criteria to be communicated to a specific competent authorities.
According to the new EU MDR, events directly involving a medical device are considered reportable under the following circumstances:
- The event caused or might cause a serious public health threat;
- The event caused death or serios deterioration of the state of the health of the patient, user or any other person involved;
- The specific event did not cause any consequence to any person, however it might led to death or serios deterioration of the state of the health of patient, user, or any other person if the event will recur. It is responsibilities of the manufacturer to establish of a specific event could cause serious consequence to patient or user; this consideration shall be based on risk management and on medical investigation performed on the specific event.
The timeline for vigilance reporting in relation to adverse event is summarized below:
- Events related to Serious Public Health Threat : must be reported immediately but not later than 2 days from the aware date.
- Events related to Death or Serious Deterioration of the state of Health of patient, user or any other person : must be reported immediately but not later than 10 days from the aware date.
- Events where there was no or little consequence to patient, or user but death or serious deterioration of the state of health are likely to occur if the event will recur: must be reported immediately but not later than 15 days from the aware date.
It is important to clarify very well the exact meaning of “serious deterioration of the state of health”, in order to clear any doubt during the evaluation of the reportability of an event or incident. Specifically, a serious deterioration in state of health can include :
- Life-threatening situations;
- permanent impairment of a body function or permanent damage to a body structure ;
- a condition necessitating medical or surgical intervention to prevent life-threatening situations or permanent impairment of a body function/damage to a body structure;
- any indirect harm as a consequence of an incorrect diagnostic or IVD test result or as a consequence of the use of an IVF/ART (In Vitro Fertilisation / Assisted Reproduction Technologies) device when used according to the Instruction for Use provided by the manufacturer.
- foetal distress, foetal death or any congenital abnormality or birth defects.
The new Manufacturer’s Incident Report (MIR) form
The new version of the Manufacturer’s Incident Report (MIR) form became mandatory starting from January 2020 and it introduces some new updates:
- Adverse events are classified using a the coding system established by the IMDRF;
- Introduction of the new concept of similar incidents and requires trend reporting for these similar incidents;
- In preparation of the EU MDR, the SRN (Single Registration Number) and the UDI (Unique Device Identification) shall be used.
Vigilance Reporting Requirements for Use Error
Use errors are a particular type of events which is basically related to an erroneous use of the device by the patient or by the healthcare professional.
According to the European Regulation, use error that caused death or serious deterioration of the state of the health of the patient or users need to be reported, according to the related timeline discussed before.
To whom To Report Incidents Incidents Involving medical Devices
Adverse events involving medical devise shall be reported to the national competent authorities of the country where the specific event occurred. This is the principle of the vigilance reporting system.
To facilitate, we report here the contact information of all the National Competent Authorities of the European countries.
It is very important to have in the QMS procedure related to European Vigilance Reporting System the address of all the European competent authorities that may be contacted in case of need. All this information can be found in this document.
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