Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

IVDD Article 17 – Wrongly-Affixed CE Marking

By Dr. Christopher Joseph Devine
Dr. Christopher Joseph Devine, President, Devine Guidance International

For this edition of DG, there is just one takeaway: there is never a good reason to have product in the European device market with a wrongly-affixed CE Mark.

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from any Member State, has determined that a CE Mark has been wrongly affixed, product better be “recalled” sorry, “withdrawn” from the EU before the ink has dried on the flame mail that the offending device manufacturer is about to receive.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?   

 
The IVDD – 98/79/EC
Article 17 – Wrongly Affixed CE Marking
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 representative
shall 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measures to restrict or prohibit the placing on the market of the product in question or to ensure that it is withdrawn from the market, in accordance with the procedure in Article 8.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.
What IVDD medical device manufacturers need to know
If a device manufacturer is working closely with their notified body and all aspects of the IVDD are being adhered to, the doctor is not sure how a wrongly affixed CE Mark can ever happen. But hey, Murphy is alive and well; and no matter how robust a quality management system (QMS) appears to be, mistakes will happen. That being said, if a device manufacturer is asked by a Competent Authority to withdraw product containing a wrongly-affixed CE Mark, they need to do so ASAP! Failure to take action will force the Member State to elevate their response, such as blocking product entry.

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.

What IVDD medical device manufacturers need to do
Article 17 of the IVDD is probably one of the easiest Articles to understand and achieve compliance. In fact, it is so easy a caveman can understand it (sorry Geico). Seriously, all the device manufacturer has to do is refrain from affixing CE Marks until receiving the appropriate correspondences and certificates from their notified body. Granted, mistakes are bound to happen. Statistically speaking, the larger the organization, the more opportunities for the injection of mistakes by the world-famous Murphy. If it has been determined that an IVDD has a wrongly-affixed CE Mark, the device manufacturer needs to recall, remove, withdraw, etc. (you select the verb choice) product immediately. There is no need for a protracted discussion, just “get er done” (thank you Larry the Cable Guy).    
Takeaways
For this edition of DG, there is just one takeaway. There is never a good reason to have product in the European device market with a wrongly-affixed CE Mark. If a Member State notices the infringement, rest assured, the Competent Authority will come calling. Once that dreaded call is received from the Competent Authority, the device manufacturer must withdraw all products with the wrongly-affixed CE Mark ASAP!

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.

References: 

  1. 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.
  2. Devine, C. (2011). Devine guidance for complying with the European medical device directive – MDD. Charleston, SC: Amazon. 
  3. Devine, C. (2011). Devine Guidance series on complying with the MDD. Published in The Medical Device Summit. 
  4. 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.

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Dr. Christopher Joseph Devine, President, Devine Guidance International