Article 18 of Council Directive 93/42/EEC, a.k.a., the Medical Device Directive (MDD) delineates the requirements for “Wrongly Affixed CE Marking.” This week’s edition of Devine Guidance (DG) is all about the mark, the whole mark, and nothing but the mark.
As Dr. D stated in the previous edition of DG, the CE Marking represents the ability of a medical device to meet its essential requirements. The notified bodies review the manufacturer’s device applications and the associated technical documentation (Technical Files or Design Dossiers) and allow device manufacturers to affix a CE Marking containing their registration number, once certification is issued.
However, what happens when a device manufacturer wrongly affixes a CE Marking to their products? In Monopoly™ land, the penalty would be; “Go directly to jail, do not pass go, do not collect $200.00. Translated into MDD speak, can you say market withdraw? Why should a device manufacturer be concerned with market withdraw for a silly little mistake like accidently placing a CE Mark on unapproved product? Because doing so violates Article 18; and in the EU, violation of the MDD is a violation of EU law. Simply stated; “Their continent, their economic community, their law.” Conversely, failing to properly affix a CE Marking onto an approved device package, prior to placing the device into commerce within the EU is also a violation of the Directive. Regardless, failing to comply with Article 18 of the Directive will have a deleterious (look-it-up) effect on the offending device manufacturer; and with that said, Dr. D can confidently state “Device manufacturers can take that to the proverbial bank.”
The MDD – 93/42/EEC
Article 18 – Wrongly CE Marking
Without prejudice to Article 8:
(a) where a Member State establishes that the CE marking has been affixed unduly or is missing in violation of the Directive, 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measures to restrict or prohibit the placing on the market of the product in question or to ensure that it is withdrawn from the market, in accordance with the procedure in Article 8. Those provisions 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 you need to know
I believe it is time for a Dr. D soapbox moment, “Device manufacturers should never attempt to affix a CE mark to their products until formal approval and certification is received from their notified body!” In fact, product can and will be held at the point of entry into the EU if product has been identified as having a wrongly-affixed CE Marking. If unapproved product has already entered into the EU, it will need to be withdrawn immediately.
Additionally, device manufacturers need to ensure approved product has a CE Mark affixed prior to shipment into the EU. It really becomes a “damned if you do, damned if you don’t” scenario. Regardless, each Member State retains the authority, under the Directive, to force a market withdraw of product failing to comply with Article 18.
Furthermore, the Directive explicitly requires Member States to force the Market Withdraw when violations of Article 18 occur. Finally, a salient point to remember is that once requested to do so by a Member State, market withdraw is the only option for a device manufacturer. There will be no need for further discussion; however, an offending device manufacturer can look forward to hearing from the Competent Authority, from the Member State forcing the market withdraw, and their notified body. The doctor guarantees, these discussions will not be pleasant.
What you need to do
Device manufacturers can keep themselves out of trouble by adhering to a couple of basic concepts. Dr. D broken-record time, number one – a device manufacturer should never affix a CE Mark to their product until formal approval and the actual certification is received from their notified body. Number two – device manufacturers should employ effective line clearance procedures in the packaging and labeling area to ensure that the CE Mark is affixed only to product that has been approved. A strong MRP/ERP System such as SAP™ can facilitate the process, along with well-written work instructions.
If an error is made in regards to wrongly affixing, or failure to affix a CE Mark is noticed, device manufacturers need to ensure corrective action is pursued immediately. If the device manufacturer notices the error prior to product entry into the EU, they may be able to recover the product and correct the discrepancy; while bypassing the joys of announcing and managing a product recall (what a nasty six-letter word).
For this edition of DG, the Doctor will leave the reader with just one takeaway: Never affix a CE Mark on device packaging until written approval and certification is received from the device manufacturer’s notified body. Let Dr. D repeat, “Never, never, never, ever, affix a CE Mark on device packaging until approval is received!” Why? Because it angers the regulatory gods in the EU, i.e., the Competent Authorities and the notified bodies. As the Incredible Hulk used to say, “You won’t like me when I am angry.” This saying applies equally to the Competent Authorities.
Until next week, when Dr. D will provide guidance for complying with Article 19 (Decision in Respect of Refusal or Restriction) 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.