|
|
In Vitro Diagnostic Directive 98/79/EC
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 the CE Mark?
The CE marking signifies that a manufacturer has declared that a product conforms to the requirements of the Directive (and any other Directives that may apply to it), and is safe for use within the European Economic Area. The CE mark alone is not a quality 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
Information on the directive and a copy of the directive text can be found on the European Commission website.
How can we gain certification to 98/79/EC?
LRQA is designated as 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
In addition, LRQA is able to perform conformity assessment activities against the directive, such as:
- 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 additional information, contact a Business Advisor at 866-563-4654 or complete the inquiry form on this website.
Why Choose LRQA?
At LRQA, we are passionate about what we do, and we understand what's at stake for your business. We work hard to apply our expertise to make your management systems more efficient and effective. This is why we are one of the world's most trusted management system assessment companies providing assurance for your business and in turn, your clients.
- Reputation and Experience – We have issued over 22 approvals at more than 22 sites to the IVD 98/79/EC. We are recognized and respected worldwide for our own high standards of technical competence, impartiality and independence.
- Assessor Expertise – We use a unique qualification coding system that matches our assessors' industry knowledge and expertise with your business needs enabling them to conduct an effective and robust audit of your system.
- Assessment Methodology – Our assessments focus on the area and issues that are important to your business. We view the process as more than just certification; we view it as a Business Assurance process that helps you assure key stakeholders that you can deliver on the promises and goals you make.
- Assessment Reports – We will provide helpful and insightful overviews in the Executive Summary, tracking of improvements in key areas in the Continual Improvement logs, and advanced views of your long term assessment plan.
- Extensive range of services – We can provide your organization with assessment, certification and verification services to support your organization's future growth and development. In addition, our comprehensive training courses offer the tools you need to prepare, implement, maintain and improve your management system.
- Integrated Assessments – We will work with you to reduce costs through the effective integration of management system assessments.
- Global Capabilities – We have over 2,000 employees offering assessments in over 30 languages. We operate a single system worldwide, which ensures that our certification process is consistent from any of our offices around the world.
LRQA Business Assurance Approach
Our Business Assurance approach to management systems assessment and reporting is unique; it's an approach that enables you to demonstrate how your system is helping to drive your business forward in a measurable and verifiable way. We believe that building trust stretches far beyond the issuing of certificates. It's about us enabling you to deliver on your promises, to be confident in your capabilities and to stand out from the crowd.
Through Business Assurance, we can help you determine whether your management system:
- helps your business to be more competitive
- supports your business objectives
- supports continual improvement
- improves stakeholder satisfaction
Read more about Business Assurance.
|