Annex IX (Classification Criteria) of Council Directive 93/42/EEC, a.k.a., the Medical Device Directive (MDD) delineates: (a) detailed definitions for the classification rules; (b) rule implementation; and (c) rule classifications; employed in support of the Directive.
For this edition of Devine Guidance (DG), Dr. D believes it would be absolutely insane to provide detailed guidance on definitions and rules; and a waste of the doctor’s coruscating (look-it-up) prose. In fact, Dr. D would equate such an effort to someone attempting to provide guidance on the definitions depicted in a Merriam-Webster’s Dictionary or equally futile attempts made to drain the Pacific Ocean. That being said, Dr. D will acknowledge that the 18 rules associated with Annex IX are mandatory. Yes, Dr. D understands that some folks just do not like to play by the rules. However, in the medical-device sandbox, device manufacturers that fail to adhere to the rules will soon shutter the windows and doors of their empty manufacturing facilities. In short, play by the rules or go home.
The full text of MDD – 93/42/EEC ANNEX IX – Classification Criteria can be viewed here
What you need to know
Device manufacturers not familiar with entering product into the European device market need to understand and grasp the significance of the rules delineated under Article IX. Probably the most salient point Dr. D can make in regards to Annex IX is the linkage between rules and device classification. For example, Rule 1 – applicable for non-invasive devices is specific to all Class I devices, unless otherwise noted. Rule 3 is typically associated with Class IIb devices, unless a device is covered by another rule due to a specific intended use. Under Rule 8, if a device can be categorized as an implantable and as a long-term surgically invasive device; and the device comes into direct contact with the heart, then the device classification will be a Class III.
So why are the definitions, rules and classifications so important? Collectively, this information is used by the notified bodies as part of the review and certification process. Additionally, this information will be depicted within the manufacturer’s Declaration of Conformity, signed by the Chief Jailable Officer (CJO), the notified body certification, and within the technical file or design dossier. Furthermore, under the changes to the Directive that went into effect in March of 2010, manufacturers of Class III and some Class IIa and IIb devices are going to be hard-pressed to receive device approval if a clinical trial has not been performed.
Finally, driven by the rules and classification, device manufacturers are expected to assembly either the technical file (Class IIa and IIb) or design dossier (Class III). This technical documentation will be shipped off to their notified body for review and approval. In repeating a point that Dr. D has made on multiple occasions, long-gone are the days when medical device manufacturers could self-certify Class IIa and Class IIb products. In today’s regulatory climate, notified bodies are reviewing technical files prior to the allowance of their CE mark of registration being affixed to medical devices. Under amendments made to the directive, notified bodies are now required to audit a statistically significant sample of technical files during their surveillance audits.
By the way, did Dr. D fail to mention device manufacturers pay the notified bodies for these reviews and audits? Just kidding folks, I believe the doctor has risen to broken-record status with comments relating to the payment of notified bodies for their services. However, you pay them and they work for you. Do not be afraid to remind them of the relationship occasionally, especially the payment part.
What you need to do
For starters, if a device manufacturer has not selected a notified body, Dr. D recommends picking a recognized organization with significant experience and familiarization with products similar to yours. Organizations such as TUV-R and BSI (the doctor is not a paid spokesperson for these organizations) are extremely competent and knowledgeable. The notified bodies can provide the necessary guidance to ensure manufacturers select the correct rules and classifications for their products. Ultimately, it will be these same notified bodies that review the technical documentation, approve the applications, and issue the certifications.
Remember, medical devices cannot ship into the EU without the CE mark affixed to the outermost packaging. Notified bodies will not allow the affixing of their CE mark of registration until all reviews have been completed, the declaration signed by the CJO received, and the certificates issued.
Dr. D had a chance to speak with a friend of his that works for a well-recognized notified body. One of the ongoing concerns he shared with me was the ongoing issues surrounding device manufacturer’s declarations of conformity and the errors being made.
That being said, the take away from this week’s guidance pertains to the accuracy of the declaration. For starters, device manufacturers need to ensure all of the information depicted within the declaration is factual and accurate. This includes the topic of this week’s topic, rules and classifications.
Since the CJO is affixing his or her John Hancock to the bottom of each declaration, it would behoove these individuals to ensure the information is correct. Dr. D has first-hand experience reviewing and rejecting literally hundreds of declarations due to errors, i.e., typos, wrong rule, wrong classification, wrong part number, missing first batch data, wrong notified body, etc. Frankly, the doctor found the number of errors to be embarrassing. Remember, accuracy counts, unless you are throwing a grenade, then “close, but no cigar” might be acceptable.
Until the next installment of DG, when Dr. D will provide guidance for complying with Annex X (Clinical Evaluation) 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.