Articles 23 and 24 of the IVDD (98/79/EC) delineate the most basic of information. Number one: The IVDD becomes law once it is scribed into the Official Journal of the European Communities. Number two: The IVDD is addressed to Member States.
Folks, it does not get any simpler than this, two one-sentence Articles (28 total words). Dr. D would never want to be accused of making an arrogating (look-it-up) decision claiming that that the doctor’s guidance is the final word when discussing Articles 23 and 24. But seriously folks, two sentences and 28-words, it really does not get any easier than this when discussing the virtues and implications associated with compliance to this Directive. Enjoy.
Article 23: This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities.Article 24: This Directive is addressed to the Member States.
Manufacturers need to know that Member States are required to comply with the IVDD. Who knew? Employing the doctor’s bourbon logic, that would mean the manufacturers of devices covered under List A or List B of Annex II shall comply with the Directive as well. Wow, the doctor is really on a roll this week. All kidding aside, Articles 23 and 24 are extremely important as they actual drive the establishment of the IVDD as European law; and the overall applicability of the IVDD for each Member State.
That being said, the best advice Dr. D can offer is to start preparing for the proposed changes coming to the IVDD. Device re-class (A through D); more devices requiring notified body oversight; additional in-house testing requirements (subject to essential requirements); specific requirements for point-of-care tests; clinical evidence (clinical validity); and companion diagnostics (demonstration of clinical utility) changes are in the proverbial pipeline. If all goes as expected, 2013 will be an interesting year as these changes take effect.
I forgot to tell the readers that Dr. D is clairvoyant; and using the doctor’s power to see into the future; Dr. D has a dire prediction. The manufacturers of devices, approved under the IVDD, will experience much angst, pain, and sorrow, if they fail to prepare and take steps to ensure compliance to the Directive is attained, post amendment. Wait, the doctor is looking into his crystal ball and sees visions of CE marks being removed from device packaging. In the background, the doctor also sees the tears slowly rolling down the face of a Chief Jailable Officer (CJO). Please prove Dr. D wrong and do not be that CJO.
Until the next installment of DG, when Dr. D provides insight and guidance into complying with Annex I (Essential Requirements) of the In Vitro Diagnostic Medical Device Directive, a.k.a., IVDD – cheers from Dr. D and best wishes for continued professional success.
- 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.
- Devine, C. (2011). Devine guidance for complying with the European medical device directive – MDD. Charleston, SC: Amazon.
- Devine, C. (2012). Devine Guidance series on complying with the IVDD. Published in The Medical Device Summit.
- Devine, C. (2011). Devine Guidance series on complying with the MDD. Published in The Medical Device Summit.
- Directive 98/79/EC. (1998, October). Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices Retrieved September 12, 2011, from http://eur-lex.europa.eu
- Polley, R. (2011, September). The future of European regulation: the proposed changes to the IVD Directive. Retrieved March 13, 2012, from http://ecdc.europa.eu/en/activities/diseaseprogrammes/TATFAR/Documents/