Analysis of vigilance data
As part of the HPRA’s on-going measures to reinforce and enhance its post market surveillance and vigilance systems all vigilance data received is being analysed under a new signal detection process. The aim of the signal detection process is to identify trends and signals in the data submitted to the HPRA, to detect if there are new risks associated with a medical device or whether known risks have changed.
Once a potential signal is identified it has to be validated before a decision on the most appropriate regulatory action can be made i.e. an in-depth signal detection investigation, referral of the information for market surveillance activities, referral of information for inspection activities or development of safety communications such as safety notices, press releases, brochures etc.
The follow up of the trends that have been noted to date has included communication with various stakeholders ; the manufacturer, the clinical community, the notified body and in some instances other European regulators.
The HPRA’s activities in this area are also preparation to the requirements outlined in Article 65a Analysis of Vigilance Data of the draft Medical Devices Regulation and Article 63a of the draft In-vitro Diagnostics Regulation.