Article 13, of Council Directive 93/42/EEC, a.k.a., the Medical Device Directive (MDD) delineates the requirements for “Decisions with Regard to Classification and Derogation Clause.” Dr. D believes that the definition of the word “derogation” is in order for this week’s edition of Devine Guidance (DG). According to Merriam-Webster’s Dictionary, the term ‘derogation’ means ‘to derogate’ (just kidding). Derogation is a transitive verb with the meaning of; “to cause to seem inferior.” A few of the synonyms associated with the verb derogate are; denigrate, diminish, discount, or in simple street lingo, trash-talk.
Somehow Dr. D does not think the Commission had the idea of trash-talking in mind when Article 13 was penned, but it is an interesting selection of a word. Can you picture a broadcaster, at a pro-sporting event, announcing; “the players are really derogating with each other today.” Not likely to happen.
In any case, this week’s guidance is about Member States questioning authority. Please do not take the doctor’s comment the wrong way in regards to authority. Dr. D does not believe Member States meet in small conventicles (look-it up) just to irk the Commission.
The MDD 93/42/EEC
Article 13 – Decisions with Regard to Classification and Derogation Clause
1. A Member State shall submit a duly substantiated request to the Commission and ask it to take necessary measures in the following situations:
a. that Member State considers that the application of the classification rules setout in Annex IX requires a decision with regard to the classification of a given device or category of devices;
b. that Member State considers that a given device or family of devices should, by way of derogation from the provisions of Annex IX, be classified in another class; c. that Member State considers that the conformity of a device or family of devices should, by way of derogation from Article 11, be established by applying solely one of the given procedures chosen from among those referred to in Article 11;
d. that Member State considers that a decision is required as to whether a particular product or product group falls within one of the definitions in Article 1(2)(a); and
e. The measures referred to in the first subparagraph of this paragraph shall, as appropriate, be adopted in accordance with the procedure referred to in Article 7(2).
2. The Commission shall inform the Member States of the measures taken.
What you need to know
As a device manufacturer, what you need to know and understand is that Article 13 provides an avenue for Member States to disagree with the Commission in regard to device classification. Sounds pretty simple right? Not exactly. The Member State must eloquently state their case as to why they disagree with the Commission’s classification rules for a specific device or family of devices. Remember, device classification is premised on the rules depicted within Annex IV (a.k.a. Classification Rules) of the Directive. Annex IV consists of five pages of text delineating 18 rules.
That said, Dr. D has to believe a classification rule exists for every-single device entered into commerce in the European Union. However, the doctor is a pragmatist; and as device technology continues to evolve, the rules will inevitably need to change.
What you need to do
As a device manufacturer, understanding the implications of Article 13 is all that is really necessary. However, if a device manufacturer strongly believes that their device is incorrectly classified, they can work through their notified body and see if a specific Member State is willing to elevate the issue to the Commission. It is the doctor’s humble opinion that these types of device classification issues, requiring a Competent Authority to petition the Commission, are rare events indeed.
The only takeaway offered by the doctor from this edition of DG is to read the Directive and understand the implications each of the Articles and Annexes have on your organization. Yes, Dr. D knows he continues to sound like a broken record with the often repeated mantra “read and comply with the regulations.” However, understanding the context of device regulations, or in the case of the current series of DG articles, the MDD, is synonymous with sustaining regulatory compliance. Remember DG Rule #1: Compliance to regulations is not optional; compliance is mandatory and dictated by law.
Until the next installment of DG, when Dr. D will provide guidance for complying with Article 14 (Registration of persons responsible for placing devices on the market) 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.