93/42/EEC Medical Devices Directive Certification

What is 93/42/EEC Medical Devices Directive certification?

The 93/42/EEC Directive is the European Union directive that sets the essential health and safety requirements for medical devices to be placed on the market and move freely in the EU. Medical device manufacturers assess their products against the applicable standards, issue a Declaration of Conformity, and obtain the CE marking. Sistem Patent Kalite provides the certification service that sits on top of this directive.

How to obtain 93/42/EEC certification

Manufacturers that need this certification open the process with an authorised certification body. Sistem Patent Kalite provides the guidance and manages the certification file through the review and the final decision.

Which products the directive covers

The directive covers a broad set of medical devices, from Class I items such as non-sterile basic instruments to Class III high-risk devices. Classification drives the depth of the review and the evidence the notified body expects to see in the technical file.

Advantages of the service

• Work led by specialists with medical device experience.
• A certification plan that fits the specific device and its classification.
• Efficient handling that keeps the file moving.
• International recognition that opens access to EU and wider export markets.

Why certification under the directive matters

93/42/EEC certification is a prerequisite for placing medical devices on the EU market. Working with Sistem Patent Kalite gives the manufacturer compliance with the directive and a documented route to market. The team supports the client at every stage of the certification cycle.