Decision 2002/364 - 2002/364/EC: Commission Decision of 7 May 2002 on common technical specifications for in vitro-diagnostic medical devices (notified under document number C(2002) 1344) - Main contents

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2002/364/EC: Commission Decision of 7 May 2002 on common technical specifications for in vitro-diagnostic medical devices (Text with EEA relevance) (notified under document number C(2002) 1344)

Official Journal L 131 , 16/05/2002 P. 0017 - 0030

Commission Decision

of 7 May 2002

on common technical specifications for in vitro-diagnostic medical devices

(notified under document number C(2002) 1344)

(Text with EEA relevance)

(2002/364/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices(1), and in particular the second subparagraph of Article 5(3) thereof,

Whereas:

• (1) 

  Directive 98/79/EC sets out the essential requirements that in vitro diagnostic medical devices must meet when they are placed on the market and conformity with harmonised standards provides a presumption of conformity with the relevant essential requirements.

• (2) 

  By way of exception to these general principles, the drawing up of common technical specifications takes account of a current practice in some Member States whereby for selected devices mainly used for the evaluation of the safety of blood supply and of organ donation, such specifications are adopted by the public authorities. These common technical specifications can be used for performance evaluation and re-evaluation.

• (3) 

  Scientific experts from various interested parties have been involved in the drafting of the common technical specifications.

• (4) 

  Directive 98/79/EC provides that Member States are to presume compliance with the essential requirements in respect of devices designed and manufactured in conformity with common technical specifications drawn up for certain devices in the highest risk category. These specifications are to establish appropriate performance evaluation and re-evaluation criteria, batch release criteria, reference methods and reference materials.

• (5) 

  Manufacturers are, as a general rule, to be required to comply with the common technical specifications. If, for duly justified reasons, manufacturers do not comply with those specifications they must adopt solutions of a level at least equivalent thereto.

• (6) 

  The measures provided for in this Decision are in accordance with the opinion of the committee set up by Article 6(2) of Council Directive 90/385/EEC(2),

HAS ADOPTED THIS DECISION:

Article 1

The technical specifications set out in the Annex to this Decision are adopted as common technical specifications for in vitro diagnostic medical devices in list A of Annex II to Directive 98/79/EC.

Article 2

This Decision is addressed to the Member States.

Done at Brussels, 7 May 2002.

For the Commission

Erkki Liikanen

Member of the Commission

• (1) 

  OJ L 331, 7.12.1998, p. 1.

• (2) 

  OJ L 189, 20.7.1990, p. 17.

ANNEX

CTS - COMMON TECHNICAL SPECIFICATIONS FOR IN VITRO-DIAGNOSTIC MEDICAL DEVICES

• 1. 

  SCOPE

These Common Technical Specifications are for the list of devices referred to in Annex II, list A:

• - 

  reagents and reagent products, including related calibrators and control materials, for determining the following blood groups: ABO system, Rhesus (C, c, D, E, e) anti-Kell,

• - 

  reagents and reagent products, including related calibrators and control materials, for the detection, confirmation and quantification in human specimens of markers of HIV infection (HIV 1 and 2), HTLV I and II, and hepatitis B, C and D.

• 2. 

  DEFINITIONS

(Diagnostic) sensitivity

The probability that the device gives a positive result in the presence of the target marker.

True positive

A specimen known to be positive for the target marker and correctly classified by...

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