Wrongly Affixing a CE Mark Could Be a Costly MistakeWrongly Affixing a CE Mark Could Be a Costly Mistake

Article 4 “Free Movement of Devices Intended for Special Purposes,” Article 17 of the MDD “CE Marking,” Article 18 “Wrongly Affixed CE Marking,” and Annex XII “CE Marking of Conformity” provide medical device manufacturers with the basic regulatory requirements for affixing the CE mark to the product (if possible), product packaging, and instructions for use (IFU), once a device application has been approved by the notified body. 

However, if a device manufacturer has wrongly affixed a CE mark (Article 18) or fails to affix a CE Mark to an approved device, Member States are required to take the appropriate steps to correct the violation of the Directive. The manufacturer or the manufacture’s EU Authorized Representative will be notified of the violation with the expectation that immediate action be taken to correct the violation. For products with a wrongly affixed CE mark, market withdraw is the only acceptable path of action. For approved devices failing to have the CE mark on the device or on device packaging, the devices will need to be removed from market and the labeling corrected to reflect the CE marking. Note the CE mark will contain the identification number of the manufacturer’s notified body. If a device manufacturer fails to withdraw product deemed in violation of the MDD, Member States will take appropriate action to block the entrance of misbranded product into the EU or prevent its distribution and sale.

The MDD is very specific about the application of the CE mark to product or packaging (Article 17) and the physical dimensions of the CE mark (Annex XII). For example, the CE Mark must be “visible, legible, and indelible” on the device (if possible), on the device packaging, and on the IFU. The size and proportions of the CE mark must be in accordance with Annex XII. If the size of the CE Mark is changed to meet packaging and labeling real-estate requirements, the CE mark must remain proportional to the drawing depicted in Annex XII. CE marks that measure less than 5 mm in size require a waiver.

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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.

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