Similar to the United States and the need to report adverse events through the use of Medical Device Reporting (MDR), the European Union (EU) employs a vigilance reporting system, MEDDEV 2.12-1, Rev 8 (Guidelines on a Medical Devices Vigilance System).
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It is imperative that device manufacturers understand the link between MEDDEV 2.12-1 and the definition of an “incident” in accordance with 4.10 of MEDDEV 2.12-1 and Article 10 of the Medical Device Directive (MDD). Article 10 of the MDD delineates the need for member states to take action when incidents are noted with medical devices approved for sale in the EU. Chances are one or two incidents are not going to force a competent authority in a member state to get overly excited. However, if a device manufacturer has medical devices racking up incidents, then all bets are off and the need for member states to pursue regulatory action will be imminent.
According to Article 10 of the MDD, the following scenarios equate to an incident:
Additionally, if there is a technical or medical reason that drives the device manufacturer to recall medical devices, then the member states will want to be informed of the issues; henceforth, the need for medical practitioners and medical institutions to notify competent authorities of incidents. Once an incident has been reported, the member state will take the lead and ensure the device manufacturer and/or EU authorized representative will be notified of the incident.
Depending on the severity of the incident, an assessment will be pursued by the member state, preferably with input from the manufacturer and/or the manufacturer’s EU authorized representative. The end result will be a determination of actions needing to be pursued to remediate and hopefully reduce the recurrence of incidents. Member states are required to inform the commission and other member states (now 28 member states) of all actions proposed or taken.
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Bob Mehta is principal consultant and recruiter of GMP ISO Expert Services, a Los Angeles/Orange/San Diego County-based consulting firm specializing in global supplier quality management, supporting quality systems for FDA-ISO-regulated companies and their professional staffing needs. Mehta has more than 22 years of experience in the fields of quality, regulatory compliance, regulatory and notified body inspections, supply management, and risk management. Mehta holds MSQA, MBA, B.S. (Chem), and ASQ - CSSBB, CQE, CRE, CSQE, CBA, CQA, CPA certifications. He serves on the committee of the Industry Board of Advisor for Medical Device Industry Education Consortium (MDIEC). He is heavily involved in remediating and implementing the risk-based quality systems and supplier audit program for Fortune 500 clients in a variety of industries, including medical device, pharmaceutical, biotech and neutraceutical.