In-Vitro Diagnostic Directive Conformity - IVD 98/79/EC

The In Vitro Diagnostic (IVD) Medical Devices Directive introduced for the first time common regulatory requirements within the European Economic Area dealing specifically with the safety, quality and performance of in vitro diagnostic medical devices (IVDs). This brings them into line with other medical devices. In essence, the Directive aims to make sure that IVDs are safe for use and meets the performance levels specified by their manufacturer.

This Directive is relevant to you if you put IVD medical devices on the market in the European Economic Area whether they are designed and/or manufactured within or outside the European Economic Area.

Your route to conformity

An in vitro diagnostic medical device is defined by the IVD Directive as “any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment or system whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information concerning a physiological state of health or disease or congenital abnormality or to determine the safety and compatibility with potential recipients”.

We are a notified body under the IVD directive for the full range of devices, under the following Annexes:

  • Annex III, section 6 - Design Examination for self-test devices.
  • Annex IV - Full Quality Assurance
  • Annex VII - Production Quality Assurance

We are able to offer conformity assessment activities against the directive, including:

  • auditing a company's quality system
  • conducting design dossier examinations for Annex II, List A devices
  • verifying that your technical documentation meets the requirements of the directive and is implemented within the system
  • carrying out verification of manufactured batches for Annex II, List A devices
  • conducting continued surveillance of the quality system.

Proposed Revision

Published by the European Commission on 26 September 2012, it's being introduced as a Regulation instead of a Directive. It aims to provide a robust, transparent and sustainable regulatory framework for in vitro diagnostic medical devices that is 'fit for purpose'.

The new In Vitro Diagnostic Regulation imposes clear and detailed rules which do not give room for divergent transposition by Member States.  Moreover, a Regulation ensures that legal requirements are implemented at the same time throughout the Union.

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