The EU In Vitro Diagnostics Directive 98/79/EC

The European Union Directive 98/79/EC concerning in-vitro diagnostic devices was ratified by the European Parliament on October 27th 1998 and has been published in the official journal of the European communities Ref. L 331, dated December 7th 1998.

The countdown towards the end of the transition period, when 'CE' marking of IVD becomes mandatory has now started.

The key dates to note are:

 

  
 Medical Devices and CE marking
Introduction
EU Medical Devices Directive
        Guide to Implementation
        Downloads - EU Directives Medical
        Downloads & Links
ISO 13485/ EN 46001 - QMS for Medical Directives
In Vitro Diagnostics Directive

Download a copy of the directive here (Adobe PDF Format)
7 Dec 1998:
Directive 98/79/EC Published		 See Official Journal of the European Communities Ref.L331
7 Dec 1999:
End of transposition period		 The transposition into national law, by the Member States should be completed within 12 months of publication.
7 June 2000:
Start of the Transition Period.		 The first 'CE' Marking possible

Member States apply the provisions of the Directive within 18 months after publication. After June 2000 and during the Transition Period, both CE- marked and non CE- marked IVD devices may be placed on the EU market (manufacturers may choose to follow either the requirements of the Directive or those of each individual Member State).
7 Dec 2003:
End of Transition Period		 Five years after the publication of the Directive. Only CE marked devices may be placed on the market.

PLACING ON THE MARKET: " The first instance where a device, other than a device intended for performance evaluation, is made available in return for payment or free of charge, with a view to distribution and/or use on the Community market"
7 Dec 2005:
End of Transition for "putting into service" 		7 years after the publication date and end of the transition for "putting into service" . Only CE-marked devices may now be put into service.

PUTTING INTO SERVICE: "The stage at which a device has been made available to the final user as being ready for use on the Community market for the first time, for its intended purpose"
 

Aims of the Directive

The Directive aims to supplement the Community legal framework governing the conditions for the placing on the market of medical devices, by extending legislation to include in-vitro diagnostic medical devices. To help ensure that uniform Community rules develop, it has been broadly based on the provisions contained in Directives 90/385/EEC (active implantable medical devices) and Directive 93/42/EEC (medical devices). In-vitro diagnostic medical devices constitute a sub-category of the medical devices defined in Directive 93/42/EEC which consists of devices used in medicine for the in-vitro analysis of specimens derived from the human body.

Medical applications include analyses to assess a person's state of health (e.g. cholesterol, pregnancy testing), to check for disease or congenital abnormality, to monitor treatment as it proceeds (for instance dose and effect of medicinal products) or to determine the safety and compatibility of donated organs or blood (e.g. testing for HIV or the hepatitis virus).

The Directive lays down the essential requirements as regards reliability of the devices with account being taken of their intended purpose, as well as in terms of the protection of users and third parties. In addition, it harmonises the conformity assessment procedures to be applied by manufacturers before they place devices on the market.

Changed Approach

Whilst the IVD Directive generally follows the approach of the general Medical Devices directive 93/42/EEC there are some principal developments:

•   List of in vitro diagnostic medical devices regarded as sensitive (Annex II of the Directive) and specific provisions for the most sensitive products
•   Specific provisions on market surveillance
•   Introduction of particular health monitoring measures
•   Rules applicable to the notified bodies

List of Sensitive Devices (Annex II)

For a whole range of in-vitro diagnostic medical devices, with the exception of self-testing devices, Article 9, in conjunction with Annex III, of the Directive provides for checking of the design and manufacture on the manufacturer's responsibility without the intervention of a third party (Notified Body). This reflects the fact that the great majority of devices covered by the Directive involve no direct risk for the patient and, with the exception of 'self test' devices, are primarily used by properly trained professionals. Furthermore, the results of the analyses may often be confirmed by other means.

However, in the case of a number of sensitive devices such as those specified in lists 'A' and 'B' of Annex II, the intervention of a notified body is needed before a device can be placed on the market. These are specific devices the accuracy of which is essential for medical practice and any malfunction of which is likely seriously to endanger health.
Annex II is divided into two lists, A and B.

List A contains devices such as reagents and reagent products for the determination of blood groups and for products used in the context of blood transfusion and the prevention of AIDS and certain strains of hepatitis.

List B contains devices such as reagents and reagent products for the determination of irregular anti-erythrocytic antibodies and of certain human infections.

  
AMTAC Certification Services