Article 9 of Council Directive 93/42/EEC, a.k.a., the Medical Device Directive (MDD) delineates the requirements for “Classification.” When entering a device into the European market, the path for conformity and the compliance with specific essential requirements is driven, in part, by the device classification.
In fact it is Dr. D’s humble opinion (ok not so humble opinion), that the European approach to device classification is significantly better than the approach pursued by FDA. The device classification is driven by the intended use of the device and augmented through the European employment of Global Medical Device Nomenclature (GMDN) codes. Additionally, device classification will drive the technical requirements in regards to the need for the compiling of a technical file or a design dossier (class III devices). Regardless, in this week’s edition of Devine Guidance (DG), the doctor will once again attempt to transform my garrulous (look-it up) writing into something that makes sense to the readers.
The MDD – 93/42/EEC
Article 9 – Classification
Devices shall be divided into Classes I, IIa, IIb and III. Classification shall be carried out in accordance with Annex IX.
In the event of a dispute between the manufacturer and the notified body concerned, resulting from the application of the classification rules, the matter shall be referred for decision to the competent authority to which the notified body is subject.
Where a Member State considers that the classification rules set out in Annex IX require adaptation in the light of technical progress and any information which becomes available under the information system provided for in Article 10, it may submit a duly substantiated request to the Commission and ask it to take the necessary measures for adaptation of classification rules. The measures designed to amend non-essential elements of this Directive relating to adaptation of classification rules shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 7(3).
What you need to know
What manufacturers need to know, in regards to Article 9, is that it establishes four classes of medical devices for the purpose of defining accurate device classification in support of device application, path of conformity, applicable essential requirements, and registration within the EU, Class I being the least stringent and Class III the most. Devices categorized as Class III will require the compilation of a design dossier; and the formal review and approval of the dossier by a notified body. The lower device classifications will require a technical file. Notified bodies are now reviewing technical files versus the previously accepted path of device manufacturer’s self-certification process, which was accepted by industry for years. Guess what? Device manufacturers can expect to experience elongated timeframes associated with this review and approval process for Class IIa, IIb, and definitely Class III devices, depending on the notified body.
Additionally, if a device manufacturer and their notified body fail to reach an agreement in regards to device classification, the Competent Authority, tasked with providing the oversight for that particular notified body, will make the appropriate decision, “and the decision of the judges is final.” Sorry, Dr. D felt compelled to toss in that remark. Furthermore, if a Member State believes that classification rules depicted within Annex IV require adaptation, due to technical progress, a request shall be made to the Commission to pursue necessary measures for adaptation of the classification rules. The actions pursued by the Commission in regards to amending non-essential requirements of the Directive and the adaption of classification rules “shall be adopted,” and “the decision of the judges” just kidding.
What you need to do
Device manufacturers need to work with their notified bodies to ensure the correct device classification, in accordance with the Directive, is selected. Notified bodies should be working with device manufacturers, well in advance, identifying the appropriate application of the classification rules, the identification of essential requirements, and the appropriate path for conformity within the EU.
Dr. D has always been a big proponent of selecting competent notified bodies. Although the doctor is not a paid spokesperson for the following notified bodies, TUV-R, BSI, NSAI, and TUV-SUD are well-respected organizations servicing the medical device industry. If you and your notified body disagree with a device classification, you have the right to question and understand your notified body’s decision in regards to the classification. Remember, at the end of the day, the notified bodies work for you “the device manufacturers” and not the other way around; although some notified bodies tend to forget the nature of this business relationship.
For this edition of DG, there is just one takeaway. Article 9 establishes the concept of device classification and delineates the employment of four device classifications; (a) Class I, (b) Class IIa, (c) Class IIb, and (d) Class III. Remember – device classification will drive the path for conformity for devices entering the EU; and ultimately the need for compiling a technical file or a design dossier to support the application process.
Until the next installment of DG, when Dr. D will provide guidance for complying with Article 10 (Information on Incidents Occurring Following Placing of 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.