Article 17, of Council Directive 93/42/EEC, a.k.a., the Medical Device Directive (MDD) delineates the requirements for “CE Marking.” Dr. D would like to begin this edition of DG with one of my broken-record comments; “No CE Marking equates to no revenue stream coming from the European Union (EU).” Why? Because having the CE Marking of conformity, visible and legible, on the outermost packaging, is a fundamental requirement.
In the previous edition of DG, the doctor discussed notified bodies and their owning of a specific registration number associated with the CE Marking. If you have not read the last edition of DG, Dr. D recommends doing so before continuing with this article.
Remember the path to conformity is premised on the classification of the device and the evidence of compliance with essential requirements delineated within the Directive. The notified body, which medical device companies pay so handsomely to help facilitate the entry of their devices into the EU, will assist in the device application and perform the actual review of the technical file or design dossier before issuing certification. The device manufacturer cannot affix the CE Marking, until certification is issued. To do so, would be a violation of the Directive and result in the immediate forced withdrawal of non-approved product from the EU, including the public flogging of an organization’s Chief Jailable Officer (CJO). Yes, Dr. D is just kidding about the public flogging.
Besides, no device manufacturer wants to endear themselves with the Competent Authorities by partaking in such a bold and brazen act. The Competent Authorities and their philippic (look-it up) aimed directly at the offending device manufacturer would be extremely painful in its own right. Ouch!
The MDD – 93/42/EEC
Article 17 – CE Marking
- Devices, other than devices which are custom-made or intended for clinical investigations, 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 XII, must appear in a visible, legible and indelible form on the device or its sterile pack, where practicable and appropriate, and on the instructions for use. Where applicable, the CE marking must also appear on the sales packaging. It shall be accompanied by the identification number of the notified body responsible for implementation of the procedures set out in Annexes II, IV, V and VI.
- 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 maybe 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 you need to know
The first thing device manufacturers need to know and understand is that affixing of the CE Marking is premised on a device meeting essential requirements. The notified body will determine if conformity has been achieved and issue certification if appropriate. Broken-record time again, “then and only then will a device manufacture legally be able to affix the CE Marking.” This is an extremely important point to takeaway form this guidance.
Additionally, there are certain dimensional requirements in regards to the CE Marking. Annex XII delineates: “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.” The notified body can help with the artwork for their CE Marking and their identification number e.g., CE0197, belonging to TUV-R. Regardless, the point that should be understood is; if the CE Marking requires resizing due to space restrictions or package dimensions, the proportions must remain constant.
Furthermore, the Directive prohibits device manufacturers from altering the CE Marking or adding additional markings, inscriptions, or anything else that would potentially confuse or intentionally mislead third parties (a.k.a., the customer). The safe rule of thumb is to ensure the CE Marking is clearly visible and legible, period!
What you need to do
Simply stated, “Device manufacturers should never affix a CE Mark to their product until certification is received from their notified body.” Dr. D strongly recommends ensuring all of the product labeling, including symbols are clear, concise, and in compliance with EN ISO 980. A watch out – if your organization has multiple notified bodies, make sure the correct CE Marking, containing the correct notified body registration number is affixed to correct product. No the doctor is not off his rocker. In fact, Dr. D has experienced the pain associated with the affixing of the incorrect CE Marking, on the wrong product, first hand.
Trust the doctor when I say, the recall and subsequent rework can be costly; including the explanation issued to multiple notified bodies explaining how such an error occurred in the first place. Yes, size matters, when talking about the dimensions associated with the CE Marking. Use Annex XII of the Directive as guidance. The key is to ensure that if resizing occurs, the elements of the CE Marking remain in proportion to each other.
For this edition of DG, there are three concepts to take away from this guidance.
- Devices entering into commerce within the EU, unless identified as custom-made or for a clinical investigation, require a CE Marking that indicates conformity to its essential requirements. A device manufacturer cannot affix the CE Marking until certification is issued by their notified body.
- The CE Marking must be visible and legible. Annex XII delineates the dimensional requirements of the CE Marking.
- The CE Marking cannot be altered, changed, improved upon, hidden, obstructed, defaced, or augmented in a manner that would result in the misleading of a third party. Remember, the notified bodies like their CE Marks, as is, and see no need for device manufacturers to improve upon this small master piece.
Until the next installment of DG, when Dr. D will provide guidance for complying with Article 18 (Wrongly Affixed CE Marking) of Council Directive 93/42/EEC, the MDD – cheers from Dr. D and best wishes for continued professional success.
- 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.
- EN 980:2008. (2010, May). Symbols for use in the labeling of medical devices. European Standard – Prepared by: Technical Committee CEN/CLC/TC 3.