Article 5 of Council Directive 93/42/EEC, a.k.a., the Medical Device Directive (MDD) defines the requirement for “reference to standards.” For regular readers of Devine Guidance (DG), you have already been exposed to Dr. D’s diatribes in regards to compliance with harmonized standards. Yes, compliance to the standards is not mandated by law; however, it is important that harmonized standards appropriate for your medical device(s) be considered. Before the doctor forgets, ensure the rationale employed to explain why a standard was not employed be documented, in writing. As always, Dr. D is more than happy to offer free advice as part of DG; and would end up with compunctious (look-it up) feelings if I failed to do so.
I know by now you must really be getting tired of reading about Dr. D and my ongoing emphasis of employing harmonized standards for product being introduced into commerce in the EU. Tough! When Dr. D needs to drive home a salient point, I have been known to become a pain in proverbial butt. That being said, the doctor always strongly recommends employing the harmonized standards for devices that are targeted for approval and entry into the European Market. Employing the harmonized standards will shorten the approval time with your notified body, and significantly reduce the number of questions asked during the submission and review process. This holds especially true for Class III devices requiring the submission to, and approval of the Design Dossier by a notified body.
On the flipside of the argument, device manufacturers can choose to ignore the employment of harmonized standards and invoke the “not mandated by law argument.” Please let me know how that works for you. Dr. D will bet it doesn’t.
The MDD – 93/42/EEC
Article 5 – Reference to Standards
Member States shall presume compliance with the essential requirements referred to in Article 3 in respect of devices which are in conformity with the relevant national standards adopted pursuant to the harmonized standards the references of which have been published in the Official Journal of the European Communities; Member States shall publish the references of such national standards.
For the purposes of this Directive, reference to harmonized standards also includes the monographs of the European Pharmacopoeia notably on surgical sutures and on interaction between medicinal products and materials used in devices containing such medicinal products, the references of which have been published in the Official Journal of the European Communities .
If a Member State or the Commission considers that the harmonized standards do not entirely meet the essential requirements referred to in Article 3, the measures to be taken by the Member States with regard to these standards and the publication referred to in paragraph 1of this Article shall be adopted by the procedure defined in Article 6.
What you need to know
Article 5 begins with a pointer to the “Journal of the European Communities; Member States.” It is important to become familiar with the journal because it contains a compiled list of harmonized standards within the European Union (EU). The journal also delineates the date a harmonized standard is first published, reference of superseded standard, and date of cessation of presumption of conformity of superseded standard. Just an FYI – the current journal update was released on 18 January 2011 (2011/C 016/02). Additionally, Member States are required by the Directive to publish the references of national standards.
Once again, you can see that this is not really rocket science. The theme throughout the Directive is consistent; the presumption of compliance to essential requirements; and the MDD places a significant amount of emphasis on the recognition and employment of harmonized standards. In short, comply with a standard, and the presumption is that compliance with the essential requirements is achieved. Additionally, Article 5 also encompasses the employment and status of national standards and scenarios where a harmonized standard does not lead to compliance with essential requirements (ref. Article 3). Furthermore, if a member state (one of 27) does not agree with the content of a standard, Article 5 provides a path for a member state to contest their disagreements with standard content. As a good friend of Dr. D’s stated, if a member state considers a standard “sub-standard” Article 5 provides a pathway for allowing a member state to pursue their grievance.
What you need to do
Not wanting to belabor a point but feeling obliged to do so, the notified bodies really prefer that harmonized standards be considered and employed whenever possible. Remember there are fabulous standards coming from organizations, other than harmonized standards. In fact, Association for the Advancement of Medical Instrumentation (AAMI) and International Safe Transit Association (ISTA) come to mind. However, Dr. D strongly recommends employing harmonized standards when qualifying devices for sale within the EU. I cannot place enough emphasis on even the simple task of considering a standard and then documenting why the standard was not employed. Remember, the goal here is to establish and comply essential requirements; otherwise, can you say no approvals for the EU?
For this week, there is just one takeaway. The notified bodies like the harmonized standards. They will make the lives of device manufacturers miserable if the manufacturers fail to embrace these same standards. As I mentioned earlier, Article 5 establishes the fact that harmonized standards are published “in the Official Journal of the European Communities” and “Member States shall publish the references of such national standards.” Collectively, regulatory and quality professionals will sleep better at night knowing that their organizations are not taking exception to harmonized standards. Dr. D will sleep better at night knowing that he is preaching to the proverbial choir.
Until the next installment of DG, when Dr. D will provide guidance for complying with Article 6 (Committee on Standards and Technical Regulations) of Council Directive 93/42/EEC, the MDD – cheers from Dr. D. and best wishes for continued professional success.
AAMI. (2011, February). Association for the Advancement of Medical Instrumentation. Retrieved February 7, 2011, from http://www.aami.org/
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.
- ISTA. (2011, February). International Safe Transit Association. Retrieved February 7, 2011, from http://www.ista.org/