Article 17 (Wrongly-Affixed CE Marking) of the IVDD (98/79/EC) delineates the requirements associated with placing the CE Mark on medical devices not approved in accordance with this Directive. As Dr. D established in the previous edition of DG, the regulatory gods in the European Union (EU) take the proper use of their CE Marks seriously. In fact, if the Competent Authority, from any Member State, has determined that a CE Mark has been wrongly affixed, product better be “recalled” sorry, “withdrawn” from the EU before the ink has dried on the flame mail that the offending device manufacturer is about to receive.
Additionally, get ready to roll out the welcome mat as the notified body will probably pay a visit to find out what in the heck is going on in your facility that could have resulted in such an egregious violation of the IVDD.
One of the beautiful aspects of the EU’s system is that when a major screw-up occurs, like placing product into commerce with a wrongly-affixed CE Mark, the device manufacturer feels the pain, and often times, so does the device manufacturer’s notified body. That being said, the splenetic (look-it-up) tone of any correspondence received from any one of the Competent Authorities is clearly enough to ruin the day of even the most weathered quality and regulatory professionals. Isn’t life Grand?
1. Without prejudice to Article 8:
(a) where a Member State establishes that the CE marking has been wrongly affixed, the manufacturer or his authorized representativeshall be obliged to end the infringement under conditions imposed by the Member State;(b) where non-compliance continues, the Member State must take all appropriate measures to restrict or prohibit the placing on the market of the product in question or to ensure that it is withdrawn from the market, in accordance with the procedure in Article 8.
2. The provisions stated in paragraph 1 shall also apply where the CE marking has been affixed in accordance with the procedures in this Directive, but inappropriately, on products that are not covered by this Directive.
Continued infringement can result in the Competent Authority having a nice fire-side chat with the offending device manufacturer’s notified body (well maybe not so nice chat). As part of this exchange, the Competent Authority can ask for certificates to be suspended. If at this point, the offending device manufacturer is still not understanding the regulatory enforcement message being sent, then maybe the replacing of the manufacturers head of regulatory affairs, a.k.a. the Chief Jailable Officer (CJO) is in order.
Until the next installment of DG, when Dr. D provides insight and guidance into complying with Article 18 (Decisions in Respect of Refusal or Restriction) of the In Vitro Diagnostic Medical Device Directive, a.k.a., IVDD – cheers from Dr. D and best wishes for continued professional success.
- Devine, C. (2009, July). Exploring the effectiveness of defensive-receiving inspection for medical device manufacturers: a mixed method study. Published doctoral dissertation. Northcentral University. Prescott Valley, AZ.
- Devine, C. (2011). Devine guidance for complying with the European medical device directive – MDD. Charleston, SC: Amazon.
- Devine, C. (2011). Devine Guidance series on complying with the MDD. Published in The Medical Device Summit.
- Directive 98/79/EC. (1998, October). Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices Retrieved September 12, 2011, from http://eur-lex.europa.eu.