98/79/EC In Vitro Diagnostic Directive: Medical
Managing the Safe Manufacture of IVD Medical Devices
The 98/79/EC Directive helps manage the safe manufacture of in vitro diagnostic medical devices...
Certification to 98/79/EC is not only advantageous - it is stipulated if you design, manufacture or distribute In Vitro Diagnostic (IVD) medical devices within the European Economic Area. In fact, products must conform to the In Vitro Diagnostic Directive (98/79/EC) before they can be placed on the market within the European Economic Area, and manufacturers have to demonstrate their product's conformity to the Directive by affixing the CE Mark.
What is 98/79/EC?
The 98/79/EC Directive is defined 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".
Examples could include:
HIV test kits
blood gas analyzers
home use pregnancy tests
blood collection tubes and specimen containers
multi-analyte control sera
immunoassay analyzers and reagent kits
blood glucose monitors for diabetics
Additional Information can be found on the European Commission website.
Why Choose LRQA?
Respected and world renowned for our market leading assurance services for over 20 years, many of the world’s leading companies choose LRQA.
We’re a designated notified body under the IVD directive for the full range of devices within the following IVD Annexes:
Annex III - Design examination for self-test devices
Annex IV - Full Quality Assurance
Annex VII - Production Quality Assurance
In addition, we’re able to perform conformity assessment activities against the directive, such as:
assessing your 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 your quality system.
Our medical assessors are industry specialists and experts who are matched with your business needs, enabling an effective and robust assessment of your systems and processes.
Our Business Assurance approach ensures our assessments focus on the areas and issues that are important to your business. As the first certification body to gain accreditation for issuing quality management system certificates, we understand system requirements and can therefore tailor our approach to help meet your objectives.
Beyond certification, LRQA provides an extensive range of services to support your business’ future growth and development, including training solutions and integrated management systems assessment.
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