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Medical Device Directive 93/42/EEC
Certification to 93/42/EEC is not only advantageous - it is stipulated if you manufacture or distribute medical devices within the European Economic Area. In fact, products must conform to the Medical Device Directive (93/42/EEC) 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 93/42/EEC?
The 93/42/EEC Directive covers all products which claim to have a medical purpose and which are used in and on the human body, from heart valves to scalpels, excluding in vitro diagnostics, which are covered in a separate directive.
The exact definition of which products are covered can be found in the directive itself, along with a set of rules which help the manufacturer determine what classification the product is. 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 93/42/EEC?
Under the medical devices directive, LRQA is designated as a notified body for medical devices using the quality system conformity routes laid out in Annexes II, V and VI.
LRQA is able to perform conformity assessment activities against the directive, including:
- audit a company's quality system
- conduct design dossier examinations for Class III devices
- verify that your technical documentation meets the requirements of the directive and is implemented within the quality system, and
- conduct 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 85 approvals at more than 110 sites to the MDD 93/42/EEC. 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:
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