Medical Device Pharmacovigilance – Introduction

All regulated countries have distinctly defined medical devices, but Global Harmonization Task Force (GHTF) defined a medical device as any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material, or other similar or related article, which is thereby intended to be used by the manufacturer for human beings for one or more of the specific purposes of:

1. Diagnosis, prevention, monitoring, treatment, or alleviation of disease or compensation for an injury 
2. Investigation, replacement, modification, or support of the anatomy or of a physiological process 
3. Supporting or sustaining life 
4. Control of conception 
5. Disinfection of medical devices 
6. Providing information for medical purposes by means of in vitro examination (such as reagents, calibrators, sample collection kits, control materials, and related instruments) of specimens derived from the human body and which does not achieve its primary intended action in or on the human body by pharmacological, immunological, or metabolic means, but which may be assisted in its function by such means.

Because these devices vary widely in type and are highly essential for patients’ care, their manufacture, distribution, and sale must be regulated to ensure their quality, safety, and efficacy. Any malfunction 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.

Medical device vigilance, as known as materiovigilance, is the collection, assessment, reporting and identification of trends in incidents resulting from the use of medical devices. Its primary purpose is to protect and improve safeguards for patients, users and others by preventing or reducing the likelihood of reoccurrence of incidents elsewhere. 

The vigilance system achieves its objectives in the following ways:

• Manufacturers and users submitting vigilance reports to the relevant competent authorities.
• Evaluation of reported incidents by the competent authorities.
• Dissemination of information, which may be used to prevent recurrence of the incident, or to alleviate the consequences of such incidents, in cases when it’s necessary to do so.
• By the device being updated, modified or taken off the market in cases when it’s necessary to do so.

To ensure the safety and effectiveness of medical devices and avoid the financial and legal liabilities associated with a device recall, medical device manufacturers began to assess and understand device risk during the product design stage of medical device development and Device manufacturers have a responsibility to implement an effective post-marketing surveillance system to ensure early identification of problems or risks and report these events to competent authorities and the Medical.