In resurrecting a phrase Dr. D employed during his discussion of the MDD in 2011, Annex X is all about the CE mark, the whole CE mark, and nothing but the mark. A pretty simple concept to grasp is that without the CE mark being conspicuously placed onto a device’s outer-most packaging, entry into the European device market is not likely to happen. In fact, wrongly affixing a CE mark to product to gain entry into the European device market is criminal. Please ensure to remind your Chief Jailable Officer (CJO) of the consequences associated with intentionally violating the laws of the European Union; and yes the IVDD is law!
For those of you that have joined Dr. D throughout this series, and suffered through some of the doctor’s tirades and moments of pontification, I thank you for your patronage. I hope Dr. D has been able to demystify the bureaucratic “argot” (look-it up) associated with the IVDD. Penning or should I say typing articles, week-after-week, on regulatory compliance is always a challenge. This holds especially true when you want to make it interesting enough to keep the readers awake. That being said, the doctor hope’s you enjoy this week’s guidance.
- 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 may be waived for small-scale devices.
- 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 an in vitro diagnostic device that is safe and effective, and capable of providing accurate and repeatable results, is to establish a Quality Management System (QMS) that is compliant with ISO 13485:2003 and the applicable Articles and Annexes of the IVDD.
- Make sure Annex II (List A versus List B Devices) is employed to guide the application process and documentation requirements.
- Establishing conformance with essential requirements (Annex I) should be considered mission critical.
- 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 EN ISO 13485:2003 and the IVDD.
- 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.
- 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, certificates, 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 IVDD, the notified body can force the removal of the CE Mark from product.
- Finally, no CE Mark means zero medical-device sales revenue coming from the EU, in short, “No Mark, No Money.”
- 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.
There are three basic rules, as Dr. D sees it in the device industry.
- Rule one – medical devices must be safe and effective in their intended use; and for IVDDs, capable of providing accurate and repeatable results.
- Rule two – Medical devices that are safe and effective are a direct result of a robust design and development process, supported by a manufacturing environment built on validated processes.
- Rule three – not having a well-documented and effective QMS, makes compliance to rules one and two, nothing more than a fairy tale.
Until the next installment of DG, when Dr. D provides an epilogue to the Devine Guidance series on complying with the In Vitro Diagnostic Medical Device Directive, a.k.a., IVDD – 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.
- Devine, C. (2011). Devine guidance for complying with the European medical device directive – MDD. Charleston, SC: Amazon.
- Devine, C. (2012). Devine Guidance series on complying with the IVDD. Published in 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.
- EN ISO 13485:2003. (2004, February). Medical devices – quality management systems – requirements for regulatory purposes (ISO 13485:2003).