Articles
What is a Vigilance Guidance Document?
by Andrew James Blogger, Writer There are many changes in the new EU MDR guidelines and so there are many new terms coming in front of medical device manufacturers, suppliers, and or persons involved in the healthcare system. These are PMS, PMCF, IVDR, vigilance, and more. Everybody is aware of PMS and PMCF as they are in news repeatedly in the European Union.Learn EU MDR in-depth here.
Today, we will discuss more in-depth about vigilance and how it is different from other medical terms.
What is vigilance?
Vigilance is a reactive process involving complaints of serious injuries or a situation where a serious injury or death occurs.
What is the difference between vigilance and PMS?
Vigilance is the set of actions that involves all process steps in the marketing of the medical device including occurring or potential incidents that one reports or is aware of.
However, PMS is the actions required for the collection and management of all the pieces of information related to a medical device or equivalent device.
What are the vigilance guidance documents?
The most recent version of the vigilance guidance documents that are being used is MEDDEV 2 12-1 Rev 8. In these guidelines IVF (In vitro fertilization )or AFR (artificial reproduction), technology devices are included to ensure the scope of vigilance guidance system.
Vigilance guidance documents are applicable to incidents occurring within the member states of Switzerland, EEA, and Turkey. The scope of vigilance guidelines are as below:
- A device that carries the CE mark
- There may be some devices that do not fall under CE. But they fall under the scope of the new regulations.
- Devices that do not have CE labels because they were in the market before the implementation of EU MDR guidelines.
A properly implemented vigilance system involves the cooperation of manufacturers, competent authorities, users, and others. Who can easily find the previously side effects of the device and can prevent future recurrence of incidents like sudden death or serious health conditions.
According to the Vigilance system, an incident is a failure or deterioration in the properties or performance behavior of the device, any false labeling or instructions for use that may lead to the death of a patient or to a serious condition of the health of a person.
Serious health condition of a person is defined as:
- a permanent illness due to any disease
- Life-threatening illness
- Fetal distress
- Fetal death
- Permanent fracture of any body part or damage to a body structure.
Bottomline
Regardless of the implementation of the PMCF trial, manufacturers still have to confirm the reactive Post market activities that include vigilance, complaint handling, clinical evaluation, databases.
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About Andrew James 
Blogger, Writer
36 connections, 1 recommendations, 120 honor points.Joined APSense since, November 8th, 2013, From Austin, United States.
Created on May 23rd 2021 22:16. Viewed 277 times.
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