Article 20a of Council Directive 93/42/EEC, a.k.a., the Medical Device Directive (MDD) delineates the requirements for “Cooperation.” Using the term cooperation in regards to a standard, law, regulation, or in the case of the MDD, a Directive, almost sounds like an oxymoron not unlike “military intelligence” or one of my favorites “genuine-artificial jumbo-shrimp.” What? Cooperation? Stealing a line from Dick Vitale, “Are you kidding me!”
All kidding aside, Dr. D loves the concept, although attempting to get all of the Competent Authorities, from 27-Member States to cooperate, is clearly a daunting task. In fact, achieving cooperation with a small, diverse, and opinionated group does not often lend itself to being an efficacious (look-it-up) approach for exchanging information and proactively developing solutions. The doctor emphatically believes there will always be disagreements and misunderstanding in pursuit of cooperation. It really boils down to the fundamentals of basic group dynamics.
The MDD – 93/42/EEC
Article 20a – Cooperation
Member States shall take appropriate measures to ensure that the competent authorities of the Member States cooperate with each other and with the Commission and transmit to each other the information necessary to enable this Directive to be applied uniformly. The Commission shall provide for the organization of an exchange of experience between the competent authorities responsible for market surveillance in order to coordinate the uniform application of this Directive. Without prejudice to the provisions of this Directive, cooperation may be part of initiatives developed at an international level
What you need to know
Under the Directive, Competent Authorities are required to cooperate when disseminating information relevant to the Directive. In fact, the Commission provides a forum for the organization and exchange of information between the Competent Authorities. The need for Member States to cooperate is an important cornerstone when it comes to post-market surveillance activities for the European Union (EU). In fact, trust Dr. D when I say, “The sharing of post-market surveillance data by the Competent Authorities has exhibited a dramatic improvement in recent years.” A good example of this cooperation can be seen in a recently developed tool, the EU’s database for capturing Vigilance Reporting Data (Medical Devices Sector – Implementation Vigilance Competent Authorities Notification Reports). Remember, the foundation for the post-market surveillance system in Europe is the Vigilance Report; and cooperation between the Competent Authorities facilitates the dissemination of post-market surveillance data.
What you need to do
As a device manufacturer, you need to understand the requirement that the Competent Authorities are obligated to cooperate in accordance with the Directive. A pragmatic approach for the sharing of information ensures that medical devices that are not safe and effective are quickly identified and removed from the European market. Can you say Recall (Dr. D’s favorite-nasty little six-letter word). If a device manufacturer is marketing devices that are safe and effective, while complying with all aspects of the Directive, there will never be a reason to worry in regards to Article 20a. It will be nothing more than just another clause. One salient point to remember is that the cooperation between the Competent Authorities is not limited to post-market surveillance. Article 20a requires that cooperation be extended toward all aspects of the MDD, in support of a uniform application of the Directive. The “all-encompassing support concept” makes Article 20a an extremely powerful clause indeed.
For this edition of DG, the doctor will leave the readers with just one takeaway. The Directive requires the Competent Authorities, from each of the Member States, to cooperate – period! Remember, the Competent Authorities are becoming very proficient in the art of cooperation.
Until the next installment of DG, when Dr. D will provide guidance for complying with Article 21 (Repeal and Amendment of Directives) 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.
- MEDEV 2.12-1 rev 5. (2007, April). Guidelines on a medical devices vigilance system. European Commission DG Enterprise and Industry. Retrieved February 26, 2011, from www.gtlaw.com/portalresource/lookup/wosid/contentpilot
- Vigilance Reports. (2011, February). Europa.en Website. Retrieved February 26, 2011, from http://ec.europa.eu/consumers/sectors/medical-devices/documents/vigilance-reports/index_en.htm