Article 4 (Free Movement) of the IVDD (98/79/EC), is very close in construction to Article 4 of the MDD minus the special purposes. Under a signed agreement between President Obama and the Commission, all medical devices shipped from the United States into the European Economic Community (EEC) can ship for free; henceforth the title, “Free Movement.” Ha, Ha, Ha, I hope the readers realize (with a z) that Dr. D is just having some fun and no such agreement exists.
1. Member States shall not create any obstacle to the placing on the market or the putting into service within their territory of devices bearing the CE marking provided for in Article 16 if these devices have undergone conformity assessment in accordance with Article 9.2. Member States shall not create any obstacle to devices intended for performance evaluation being made available for that purpose to the laboratories or other institutions listed in the statement referred to in Annex VIII if they meet the conditions laid down in Article 9(4) and Annex VIII.3. At trade fairs, exhibitions, demonstrations, scientific or technical gatherings, etc. Member States shall not create any obstacle to the showing of devices which do not conform to this Directive, provided that such devices are not used on specimens taken from the participants and that a visible sign clearly indicates that such devices cannot be marketed or put into service until they have been made to comply.4. Member States may require the information to be supplied pursuant to Annex I, part B, section 8 to be in their official language(s) when a device reaches the final user. Provided that safe and correct use of the device is ensured, Member States may authorize the information referred to in the first subparagraph to be in one or more other official Community language(s).In the application of this provision, Member States shall take into account the principle of proportionality and, in particular:
(a) whether the information can be supplied by harmonized symbols or recognized codes or other measures;(b) the type of user anticipated for the device.
5. Where the devices are subject to other directives concerning other aspects which also provide for the affixing of the CE marking, the latter shall indicate that the devices also fulfill the provisions of the other directives.However, should one or more of these directives allow the manufacturer, during a transitional period, to choose which arrangements to apply, the CE marking shall indicate that the devices fulfill the provisions only of those directives applied by the manufacturer. In this case, the particulars of these directives, as published in the Official Journal of the European Communities, must be given in the documents, notices or instructions required by the directives and accompanying such devices.
- Member States shall not block the entry of devices that contain a legally affixed CE Mark;
- Member States shall not block the entry of devices being used for performance evaluation;
- Member States shall not block the entry of non-CE marked devices to be used as samples only (not for human use);
- Member States can require device labeling and Instructions for Use (IFU) be provided in their native tongue; and
- When applicable, devices that fall under the jurisdiction of multiple Directives must comply with the appropriate Articles and Annexes of these Directives prior to the affixing of a CE Mark.
- 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.
- 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