Medical Device Directive 93/42/EEC
Managing the Safe Manufacture of Medical Devices
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.
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 MDD 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.
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 medical companies choose LRQA.
We’re designated as a notified body Under the medical devices directive for medical devices using the quality system conformity routes laid out in Annexes II, V and VI.
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 Class III devices
verifying that your technical documentation meets the requirements of the directive and is implemented within the quality system, and
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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