Annex XII (CE Marking of Conformity) of Council Directive 93/42/EEC, a.k.a., the Medical Device Directive (MDD), is all about the Mark, the whole Mark, and nothing but the Mark.
All kidding aside, the regulators in the European Union (EU) are very much in love with their CE Mark and frown down upon those who attempt to change it. For those of you that are aficionados of classic rock and roll, would you like to see Led Zeppelin’s Stairway to Heaven played as a country music ballad? I am sure that answer is probably a resounding “not a chance!” Well guess what, regulators in the EU do not want to see their CE Mark modified to look like something Pablo Picasso may have painted. Yes, I know – bad analogy Dr. D, but as I often say; “This is my column.”
Since Annex XII is by-and-far the shortest Annex, the doctor will focus on a few of the salient requirements to obtain the CE marking of conformity, and equally important, keeping the CE Mark. Dr. D will also provide some brief insight into the design of the CE Mark, the object of Annex XII and this week’s guidance. As with all of the Doctor’s fine prose, I hope the readers will not castigate or threaten defenestration (look-it-up) just because Dr. D’s strong opinions may be obverse to the opinions held by some of the readers. Regardless, the doctor hopes you thoroughly enjoy this final installment of this series “Devine Guidance for complying with the MDD.”
The MDD – 93/42/EEC
ANNEX XII – CE Marking of Conformity
The CE conformity marking shall consist of the initials ‘CE’ taking the following form:- If the marking is reduced or enlarged the proportions given in the above graduated drawing must be respected.
- The various components of the CE marking must have substantially the same vertical dimension, which may not be less than 5 mm.
- This minimum dimension maybe waived for small-scale devices.
What you need to know
Like Dr. D mentioned in the intro to this edition of DG, I will provide some of the salient points associated with the obtainment and retention of the CE marking of conformity.
- The CE Mark and registration number belong to the notified body. It is through their good graces that device manufacturers have permission to affix the CE Mark to their product.
- The first step in the CE Mark adventure, apart from developing a medical device that is safe and effective, is to establish a Quality Management System (QMS) that is compliant with ISO 13485:2003.
- Applications for Class IIa and IIb devices require a technical file to be compiled. Chances are pretty darn good the notified body will want to review the technical file. Long gone are the days of “just trust us” and “self-certification.”
- Applications for Class III devices require a design dossier to be compiled. The notified bodies are required to review the design dossier.
- The notified bodies will assess a device manufacturer’s QMS and issue a certificate stating compliance, if the QMS is deemed in compliance with the standard.
- Regardless of device classification or rule, medical devices must conform to their established essential requirements. In fact, an Essential Requirements Checklist (ERC) is a salient requirement for all submissions.
- The Chief Jailable Officer (CJO) will need to review, approve, and sign a Declaration of Conformity (DoC) for each of the devices and/or device families submitted to the notified body for review. A copy of the DoC shall be placed into the technical files and design dossiers.
- It is a violation of European law to ship medical devices into the EU, for commerce, without a CE Mark.
- It is a violation of European law to ship medical devices into the EU, for commerce, with a wrongly affixed CE Mark.
- Device manufacturers are not permitted to affix a CE Mark until all of the appropriate documentation and approvals have been received from their notified body.
- If it has been determined through vigilance reporting or some other means that devices shipped into the EU are not safe and effective, device manufacturers must take immediate action. The notified body can force the removal of the CE Mark from the offending product.
- If a device manufacturer fails to maintain their QMS in accordance with ISO 13485:2003; and in accordance with the Annexes of the MDD, the notified body can force the removal of the CE Mark from product.
- Finally, no CE Mark means zero (0) medical-device sales revenue coming from the EU, in short, “No Mark, No Money.”
Getting back to the CE marking of conformity, the topic of this edition of DG, there are three basic components associated with Annex XII.
- If the device manufacture decides to enlarge the CE Mark or shrink the CE Mark, the proportions of the mark must be sustained. In short, device manufactures cannot have: (a) a big C followed by a little E; (b) a little C followed by a big E; (c) a fat C followed by a skinny E; (d) a skinny C followed by a Fat E; (e) or any combination of a through d.
- The Annex prescribes a minimum vertical dimension of 5 mm for the CE Mark.
- If it is not possible to meet the 5 mm requirement due to space constraints, the CE Mark can be reduced in size; however, the proportions must be maintained in accordance with bullet-point one.
What you need to do
Dr. D strongly recommends that the graphic art’s folks, supporting a device manufacturers’ labeling and packaging functions, get the artwork for the CE Mark correct on the first pass. There is nothing like making a good first impression. Remember, when submitting technical documentation (technical files and design dossiers) to the notified body, they are going to want to review the labeling. Labeling will include the device carton (box) label, device pouch label, and the Instructions for Use (IFU), as appropriate. If the CE Mark is wrong, it will be back to the drawing board. Another Dr. D watch-out pertains to device manufacturers that employ multiple notified bodies. Make sure the correct CE Mark is placed on the correct product. Nothing says were out of control more than misbranded product. Simple stated; the placement of the wrong CE Mark, onto the wrong product, is considered misbranding.
Takeaways
From this edition of DG, the message is quite clear. The regulatory gods in the EU like their CE marking of conformity just as the mark is depicted in Annex XII. There is no need to improve on the already perceived perfection in mark design. In fact to do so, is a violation of the Directive. The size and proportion requirements for the CE marking of conformity are clearly depicted in Annex XII. Dr. D’s best advice is to abide by the Annex and leave perfection alone.
Until the next installment of DG, when Dr. D commences with the launching of a new series, Devine Guidance for Complying with Directive 98/79/EC, the In Vitro Diagnostic Medical Device Directive, a.k.a., IVDD – cheers from Dr. D and best wishes for continued professional success.
References:
- Council Directive 93/42/EEC. (1993, June). Council Directive 93/42/EEC concerning medical devices. Retrieved December 21, 2010, from http://eur-lex.europa.eu
- 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.
- 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
- EN ISO 13485:2003. (2004, February). Medical devices – quality management systems – requirements for regulatory purposes (ISO 13485:2003).
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