Devine Guidance
IVDD Article 16 – CE Marking

Dr. Christopher Joseph Devine, President, Devine Guidance International

Article 16 (CE Marking) of the IVDD (98/79/EC) delineates the use of the CE marking of conformity and what the CE mark actually represents. Just in case some of you folks have been living in a quality or regulatory cave, Dr. D has taken the liberty of placing an example of the CE mark in this edition of Devine Guidance (DG). Now before you commence with the cursing and the insults directed at the doctor’s condescending attitude, there are folks out there that have not had the pleasure of viewing a correctly structured CE Mark; and no, Dr. D is not kidding. For you “know-it-alls,” you just might want drop in on your packaging and graphics folks to ensure the CE mark still resembles my depiction and the construction requirements delineated under Annex X of the IVDD. In short, it better look like the one the doctor has taken the liberty to cut-and-paste into Figure 1. If not, fix it. Why? The doctor will tell you why, because the notified bodies are getting pretty darn tired of having their CE Mark of registration soiled with incorrect depictions of their mark of registration, that’s why (more to come when Dr. D dissects Annex X sometime in May).

Now the doctor clearly understands that the some readers of DG, with a low tolerance for fustian (look-it-up), just might be turned off by Dr. D’s prose. However, the doctor is just attempting to pump some life into a mundane topic, regulatory compliance, while providing some wisdom that will keep device manufactures out of regulatory Hades. Depending on your device and the country the device is marketed in, compliance with the IVDD, MDD, AIMDD, QSR, CMDCAS, TGA, etc. (enough acronyms for today) is not optional. Compliance to the laws regulating medical devices is mandatory. Dr. D did not create these regulations. Dr. D does not enforce these regulations. Dr. D only attempts to educate in regards to the applicability of these regulations. 

 
The IVDD – 98/79/EC
Article 16 – CE Marking
  1. Devices, other than devices for performance evaluation, considered to meet the essential requirements referred to in Article 3 must bear the CE marking of conformity when they are placed on the market.
  2. The CE marking of conformity, as shown in Annex X, must appear in a visible, legible and indelible form on the device, where practicable and appropriate, and on the instructions for use. The CE marking of conformity must also appear on the sales packaging. The CE marking shall be accompanied by the identification number of the notified body responsible for implementation of the procedures set out in Annexes III, IV, VI and VII.
  3. It is prohibited to affix marks or inscriptions which are likely to mislead third parties with regard to the meaning or the graphics of the CE marking. Any other mark may be affixed to the device, to the packaging or to the instruction leaflet accompanying the device provided that the visibility and legibility of the CE marking is not thereby reduced.
What IVDD medical device manufacturers need to know
What the doctor is about to divulge is not a state secret or an epiphany that came to Dr. D in a dream. If device manufacturers want to sell IVDDs into the EU, a CE Mark is needed. The CE Mark is rented from a notified body. Yes, the term rent is probably not appropriate, but it is probably not far from the truth. Device manufacturers pay their notified bodies for use of their CE Mark; and if the quality system is deemed effective, and the IVDDs meet their established essential requirements, then a CE Mark can be affixed to the product packaging and labeling. Since the manufacturer does not own the CE Mark, it really is just a rental. 
The notified bodies and the EU regulatory gods, in general, like their CE Mark to be visible and legible. For the packaging engineers reading DG, the labels better be able to past the “Sullivan Rub Rest.” As funny as it sounds, no, Dr. D is not making up a test requirement. The Sullivan Rub Test really does exist, just not in Wikipedia.

Another point that needs to be made is in regards to accuracy. For you device manufacturers that retain multiple notified bodies, please ensure the correct CE Mark is placed onto the correct product packaging. Yes, Dr. D can already hear some of snide comments, “Misbranding with incorrect CE Marks never happens.” If anyone believes that fallacy, Dr. D owns a 50 percent stake in the Bay Bridge and I am putting it up for sale. All kidding aside, the wrong CE Mark affixed to the wrong product is considered misbranded in all 27-Member States. Can you say recall (excuse me, market withdraw)?

Dr. D has also had a “regulatory expert” try to tell me that if a device manufacturer changes notified bodies, there is a grace period for incorporating the new CE Mark. Remember, the doctor has a bridge for sale. Once the decision is made to change a notified body (let’s say 12/31/2011 was the effective date) product being manufactured in January 2012 better not have the old CE Mark. Why? BECAUSE THAT WOULD RESULT IN MISBRANDED PRODUCT! The notified bodies feverishly protect their CE Mark of registration, as well they should. In short, if device manufacturers fail to pay their notified bodies, they cannot use their CE mark; it is that simple.

Finally, it is not nice to attempt to fool or mislead third-parties (e.g., customers) by manipulating the CE Mark: (a) the visibility of the Mark; (b) the graphics associated with the Mark; or (c) attempting to enhance the Mark. The regulatory gods in the EU like their Mark as is, so there is no need for improvement. In fact, the notified bodies are mostly in agreement (a rare event indeed) that there needs to be consistency in regards to CE mark construction (Annex X) and visibility.
    
What IVDD medical device manufacturers need to do
You can call Dr. D crazy, but adherence with Article 16, without reservations, is a nice place to start. The affixing of a CE mark to product packaging is one of the cornerstones for entering product into commerce in the EU. This is probably not going to change in Dr. D’s lifetime. Take it to the bank, just not the European Databank. The notified bodies have worked really hard to obtain the right to have their CE Mark. It is the cornerstone for their business. Their expectations are pretty straight forward:
Takeaways
In closing, the doctor would like to apologize if this DG has been more caustic then usual. However, I really do get tired of hearing about how some device companies attempt to rationalize the silliness that deviations from the IVDD are acceptable in the eyes of the notified bodies. I assure you, they are not. The CE Mark does belong to your notified body. As the doctor stated earlier, device manufacturers pay for the use of the CE Mark; henceforth, Dr. D’s comparison to a rental. Finally, once all of the certificates have been received from the notified body, ensure the CE Mark is correctly designed prior to incorporating the CE Mark into product packaging and labeling.

Until the next installment of DG, when Dr. D provides insight and guidance into complying with Article 17 (Wrongly Affixed CE Marking) 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 series on complying with the MDD. Published in The Medical Device Summit. 
  3. 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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