The In Vitro Diagnostic (IVD) Medical Devices Directive is relevant to you if you design, manufacture or distribute IVD medical devices within 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.
Your next step
We are a notified body under the IVD directive for the full range of devices, under the following Annexes:
- Annex III - 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 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 of defined high risk IVDs
- conducting continued surveillance of the quality system.
For a copy of the form or for further information, please call 0800 783 2179 or complete the enquiry form on this website for further information.
We also offer :
Lloyd's Register Quality Assurance • A member of the Lloyd's Register Group
