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.
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.
- 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.
- 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 series on complying with the MDD. Published in The 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.