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.
- 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.
- 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.
- 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.
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.
- Do not affix the CE Mark to product until the device application has been approved and the appropriate certificates have been issued;
- If a device manufacturer has multiple notified bodies, ensure the correct CE Mark is affixed to the correct product;
- Make sure the CE Mark is constructed in accordance with Annex X of the IVDD;
- If asked to remove the CE Mark, do so quickly, e.g., ASAP; and
- The notified bodies like to be paid on time (for my notified body friends, you are welcome).
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.
- 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 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.