So why is the safeguard clause so darn important? Can you say market withdraw? The short and sweet answer is that the safeguard clause can be used by EU member states to quickly pursue an appropriate path of action when medical devices that have entered into the European market are deemed not to be safe and effective. When a member state has ascertained that a medical device can adversely impact the health and safety of patients and users, it is required by the Medical Device Directive (MDD) to immediately pursue the market withdraw for the suspect medical device.
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Once a member state has made the decision to force a market withdraw or block entry of a medical device into the EU, the member state is required to notify the commission immediately. Additionally, the member state must provide valid reasons for its decision to force a product withdraw and/or block entry of a device. Article 8 delineates three salient reasons for such a decision being made, as related to a failure to comply with the MDD. For example: (a) a device failing to meet its essential requirements as delineated under Article 3 of the MDD; (b) the incorrect applications of standards, as delineated under Article 5 of the MDD (claiming compliance to a standard that has not been applied or properly applied); and/or (c) the standard has an issue (not effective). However, it should be noted that the decision of a member state is not necessarily final. For example, the commission is tasked with bringing all concerned parties to the proverbial table and determining if the actions taken are actually justified.
If the measures are deemed to be justified: (a) the commission will notify all member states; and (b) oversee the amending of nonessential elements of the MDD. Remember, the fundamental goal is to protect the health and safety of the patient and user. If the commission determines the actions pursued by the member state are unjustified, the commission is tasked with the immediate notification of the member state, which initiated the action, and the medical device manufacturer and/or its authorized representative. Finally, if it has been determined that a noncompliant device has a CE Marking of Conformity affixed to the product and/or packaging, member states are required to take appropriate action, including informing the commission and other member states of the violation of the directive.
In closing, the best practice is always to:
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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.