Market vigilance

The basic regulatory strategy employed to safeguard public health relies on focussing attention on three main areas of activity product development product manufacture and market vigilance (see Figure 2.1). 

Operation of market vigilance systems at national level. 

Market Vigilance and Oversight of Drugs 253 2. Definition of Significant Deficiencies... 

Despite the extensive investigations that must be undertaken prior to placing a drug on the market, it is not possible to guarantee that all safety issues have been identified. Thus, market vigilance systems must be maintained after a dmg has been launched so as to detect safety issues that were not evident prior to commercialisation. For such systems to be effective requires the participation and cooperation of the medical profession, the pharmaceutical industry and the regulators, in order that critical safety information can be identified and acted on in a timely manner. In some... 

Just as with drugs, market vigilance systems are required to ensure that problems with devices are identified and addressed in a timely manner. Although they share... 

Market Vigilance and Oversight of Devices 263 Table 12.3 Su mmary of periodic reporting obligations in the US. 

The responsibilities of Competent Authorities in terms of market vigilance are set out in the Articles of the device directives, whereas the obligations for manufacturers are contained in the Armexes. MEDDEV guide 2.12-1 provides detailed practical guidance on how the medical device vigilance system should operate within the EU, the European Economic Area (EEA) and Switzerland. This guidance was significantly... 

The requirements for market vigilance and oversight in the US are set out in 21 CFR 803, Medical Device Reporting, 21 CFR 806, Reports of Corrections and Removals and 21 CFR 822 Post market Surveillance. 

One of the main requirements is the verification of the biocompatibility and a risk management, which have to consider the results of a clinical study and post-marketing (vigilance) studies [17]. 

Phase 4 — once the drug has been approved for market, vigilant post-marketing surveillance is done to ascertain the possible appearance of previously undetected tox-icities or problems. 

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