Although the IVDD was originally drafted in 1998 (henceforth the 98 in 98/79/EC), compliance to the provisions of this Directive was not required until June of 2000. Considering Dr. D is sometimes known for his lack of duende (look-it-up), as the doctor has repeatedly failed all attempts at making it through charm school, the doctor hopes the readers enjoy this week’s brief edition of Devine Guidance (DG).
1. Member States shall adopt and publish the laws, regulations and administrative provisions necessary to comply with this Directive not later than 7 December 1999. They shall immediately inform the Commission thereof.Member States shall apply these provisions with effect from 7 June 2000.When Member States adopt these provisions, they shall contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States.
2. Member States shall communicate to the Commission the texts of the main provisions of domestic law which they adopt in the field governed by this Directive.3. The Committee referred to in Article 7 may undertake its tasks from the date of entry into force of this Directive. The Member States may take the measures referred to in Article 15 as from the entry into force of this Directive.4. Member States shall take the necessary action to ensure that the notified bodies which are responsible pursuant to Article 9 for conformity assessment take account of any relevant information regarding the characteristics and performance of such devices, including in particular the results of any relevant test and verification already carried out under pre-existing national law, regulations or administrative provisions in respect of such devices.5. During a period of five years following the entry into force of this Directive, Member States shall accept the placing on the market of devices which conform to the rules in force in their territory on the date on which this Directive enters into force. For an additional period of two years, the said devices may be put into service.
- 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