Devine Guidance
IVDD Article 14 – The Derogation Clause

Dr. Christopher Joseph Devine, President, Devine Guidance International

Article 14 (Amendments to Annex II, and Derogation Clause) of the IVDD (98/79/EC), is all about derogating (ha, ha, ha, just kidding). Dr. D will like to begin this edition of Devine Guidance (DG) by providing the readers with a definition of the word derogation. According to Merriam-Webster’s Dictionary, derogation means to derogate (ha, ha, ha just kidding, again). No seriously, derogation is the noun form rooted in the intransitive (look-it-up) verb form of derogate. In short, it means, “to act beneath one’s position or character, or detract.” Using street lingo, the doctor believes the appropriate term would be trash talking. As much as Dr. D likes a little bit of humor; somehow, I think the regulatory gods in the EU would struggle with an Article entitled “Trash-Talking Clause,” kind of catchy though. 

 
In regards to Article 14, simply stated, “Derogation Clause” implies that an IVDD has not met the conformity assessment procedures delineated within Article 9 of the Directive. That being said, this week’s edition of DG will dive into the meaning and requirements of Article 14 of the IVDD.
 
The IVDD – 98/79/EC
Article 14 – Amendments to Annex II and Derogation Clause)
 
1. Where a Member State considers that: (a) the list of devices in Annex II should be amended or extended; or (b) the conformity of a device or category of devices should be established by way of derogation from the provisions of Article 9, by applying one or more given procedures taken from amongst those referred to in Article 9, it shall submit a duly substantiated request to the Commission and ask it to take the necessary measures.
 
Where those measures concern matters referred to in point (a), designed to amend non-essential elements of this Directive, they shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 7(3).
 
Where those measures concern matters referred to in point (b), they shall be adopted in accordance with the regulatory procedure referred to in Article 7(2).
 
2. When a measure is to be taken in accordance with paragraph 1, due consideration shall be given to:
(a) any relevant information available from the vigilance procedures and from external quality assessment schemes as referred to in Article 11;
(b) the following criteria:
(i) whether total reliance has to be placed on the result obtained with a given device, this result having a direct impact on subsequent medical action, and
(ii) whether action taken on the basis of an incorrect result obtained using a given device could prove to be hazardous to the patient, to a third party or to the public, in particular as a consequence of false positive or false negative results, and
(iii) whether the involvement of a notified body would be conducive to establishing the conformity of the device.
 
3. The Commission shall inform the Member States of the measures taken and, where appropriate, publish these measures in the Official Journal of the European Communities.
 
What IVDD medical device manufacturers need to know
For starters, a Member state has the right to request a change or an amendment to the list of devices, List A or List B delineated under Annex II of the Directive, from the Commission. Now when Dr. D was a young Marine, I had a colorful squadron sergeant-major that was always able to provide valuable insight with his pearly words of wisdom. One of his favorite expressions was (cleaned up for this article); “Marine, you can crap in one hand and make requests in the other, and see which hand fills up first.” Dr. D is absolutely sure there is some truth in his wisdom. Anyhow, the bottom line here is that a regulation or requirement can change or adapt to the needs of a Member State. However, at the end of the day it is still about establishing conformity with essential requirements. 
 
When evaluating potential amendments to non-essential elements of the Directive, the Commission will glean information from vigilance procedures and external quality assessments in regards to an IVDD. Additionally, there are three pieces of salient criteria the Commission will consider prior to rending a decision:
  • The amount of reliance on the results obtain through the use of a device;
  • The potential for injury to a patient, a third-party, or even the public, if the device provides an output (result) that is not accurate (e.g., false positive or negative); and
  • The value of having the notified body to assist in establishing conformity to essential requirements, for the device in question.
The good news is, regardless of the opinion rendered by the Commission, the Directive requires them to inform Member States of their actions and publish the measures in the Official Journal.
 
What IVDD medical device manufacturers need to do
As a manufacturer, you need to keep your notified body engaged in the process should the path of invoking Article 14 become necessary. You do remember the notified body right? These are the folks that medical device manufacturers reward handsomely, year-after-year, for the rental of their CE Marking of Conformity. All kidding aside: (a) they work for you; (b) you pay them; and (c) you should make sure you get your money’s worth. Good notified bodies will assist in the navigation of the sometime treacherous regulatory waters associated with the EU. 
 
Additionally, the notified bodies should be able to help in identifying the correct list to use (List A or B) and the specific device requirements in support of establishing conformity to essential requirements. Finally, the winds of change are blowing. There will be changes coming to the IVDD, with a significant change to the use of the lists depicted in Annex II. 
 
BSI is holding a webinar on January 26 to discuss proposed changes to the Directive; and Dr. D strongly recommends attendance (register through Medical Device Summit’s home page). 

 

Takeaways
There are two takeaways from this week’s guidance: One, Member States retain the right to (a) request revision(s) to the list of devices delineated under Annex II of the IVDD, and (b) pursue device conformity via the derogation from provisions established by Article 9. Two, the Commission will not blindly make a decision and will review available device information, including vigilance procedures, prior to rendering an opinion. 
 
Until the next installment of DG, when Dr. D provides insight and guidance into complying with Article 15 (Notified Bodies) of the In Vitro Diagnostic Medical Device Directive, a.k.a., IVDD, cheers from Dr. D and best wishes for continued professional success.
 

References: 
  1. 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.
  2. Devine, C. (2011). Devine Guidance series on complying with the MDD. Published in The Medical Device Summit. 
  3. 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.

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