|The Dr.D’s new entity—Devine Guidance International, Inc.—was incorporated a few weeks ago and opened an office in Las Vegas, NV. Please feel free to visit Dr. D’s new Website http://devineguidanceinternational.com.|
Article 14a, of Council Directive 93/42/EEC, a.k.a., the Medical Device Directive (MDD) delineates the requirements for “European Databank.” This edition of Devine Guidance (DG), simply put, relates to the European Union (EU) and their need to develop a standardized format for data collection associated with medical devices; and a receptacle for collecting voluminous amounts of data.
Simply collecting data and housing it in a vitrine (look-it-up) just for the sake of having it, makes zero sense. An FYI from Dr. D: According to the Directive, the provisions of Article 14a must be incorporated by 5 September 2012 with a review by the Commission the following month. Getting 27 member states to agree on data format and the appropriate platform for the databank must have been an interesting endeavor indeed.
That said, the European Databank on Medical Devices (EUDAMED) is currently live (beta site) with a handful of member states using it on a voluntary basis. Dr. D strongly suggests checking out the Website; however, the site’s data access is restricted and not available to the general public. The purpose of EUDAMED is to “strengthen market surveillance and transparency” for medical devices in the EU. The databank provides real-time information to the Competent Authorities from each Member State.
The MDD – 93/42/EEC
Article 14a – European Databank
1. Regulatory data in accordance with this Directive shall be stored in a European database accessible to the competent authorities to enable them to carryout their tasks relating to this Directive on a well- informed basis. The databank shall contain the following:
(a) data relating to registration of manufacturers and authorized representatives and devices in accordance with Article 14 excluding data related to custom-made devices;
(b) data relating to certificates issued, modified, supplemented, suspended, withdrawn or refused according to the procedures, as laid down in Annexes II to VII;
(c) data obtained in accordance with the vigilance procedure as defined in Article 10; and
(d) data relating to clinical investigations referred to in Article 15.
2. Data shall be forwarded in a standardized format.
3. The measures necessary for the implementation of paragraphs 1 and 2 of this Article, in particular paragraph 1(d), shall be adopted in accordance with the regulatory procedure referred to in Article 7(2).
4. The provisions of this Article shall be implemented no later than 5 September 2012. The Commission shall, no later than 11 October 2012, evaluate the operational functioning and the added value of the databank. On the basis of this evaluation, the Commission shall, if appropriate, present proposals to the European Parliament and the Councilor present draft measures in accordance with paragraph 3.
What you need to know
As a device manufacturer, Article 14a is nothing more than an FYI. The Article has several salient points you should be familiar with, including the employment of the Global Medical Device Nomenclature (GMDN) code for your devices. The salient requirement for Article 14a is that a regulatory database shall be developed. As Dr. D stated in the opening paragraph, this has successfully occurred under the name of EUDAMED, with a working beta site available for use by the Competent Authorities.
As a minimum, the databank shall contain:
- Manufacturer’s registration data;
- European Authorized Representative data;
- Device registration data (excluding custom-made devices);
- Certification data (issued, modified, supplemented, suspended, withdrawn and/or refused);
- Data collected in support of vigilance procedures; and
- Data for clinical investigations.
The next requirement of Article 14a is that the format for data will need to be
standardized. Obviously, for the databank concept to work efficiently, the data must be organized in a format that supports the databank’s architecture. Standardization of the data format is the only real plausible approach. Employment of the GMDN becomes an important input for EUDAMED in support of standardization.
Remember, the key dates associated with the implementation of Article 14a are September 5, 2012 and October 11, 2012. The first date is the completion of implementation activities (looks like an early success); and the second date, the evaluation of the databank by the Commission. From Dr. D’s perspective, I guess the Commission felt compelled to ensure the databank was fully operational before 12/21/12, the official end of the Mayan Calendar!
What you need to know
As the doctor stated earlier, there is no immediate impact for device manufacturers other than ensuring your products have the correct GMDN associated with them. However, Dr. D is a gambling man. That said, I bet that someday there will be changes in the approach notified bodies take to manage their certificates, including the look and content. It would make sense to have a standardized format for certificates; and I suspect this will be coming. Then again, Dr. D could be wrong. Regardless, the probability for standardization of certificates can be found somewhere between pipedream and conjecture on the part of Dr. D.
For this edition of DG, the only takeaway for device manufacturers is that the EU continues with their pursuit of standardization in supporting the establishment of effective data management, with the development and launch of EUDAMED, their new databank. Dr. D loves standardization because when it is pursued, with some intelligence, the end result is the creation of tools that make device manufacturers’ lives a bit easier.
The doctor does strongly recommend a review of products to ensure devices are properly assigned the correct GMDN. Your notified body can help with this task. On the flip side of the argument, the EU will be better able to manage the regulatory aspect of medical devices. Problem devices and device manufacturers will be able to be identified quickly and the appropriate regulatory action pursued.
Until the next installment of DG, when Dr. D will provide guidance for complying with Article 14b (Particular Health Monitoring Measures) 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.
- EUDAMED. (2010, June). European databank on medical devices. Retrieved April 25, 2011, from http://ec.europa.eu/consumers/sectors/medical-devices/market-surveillance-vigilance/eudamed/