90/385/EEC Active Implantable Medical Devices Certification

What is 90/385/EEC Active Implantable Medical Devices certification?

The 90/385/EEC Directive is the European Union directive that sets the essential health and safety requirements for active implantable medical devices to be placed on the market and move freely within the EU. Under this directive, manufacturers assess their products against the applicable standards and receive the Declaration of Conformity and the CE marking. Sistem Patent Kalite provides the certification service that sits on top of this directive.

How to obtain 90/385/EEC certification

Manufacturers that want this certification open the process with an authorised certification body. Sistem Patent Kalite gives them the guidance and consultancy they need and manages the file through to the certification decision.

Which products the directive covers

The directive applies to active implantable medical devices, that is, devices surgically placed inside the human body that depend on an external or internal energy source to function. Pacemakers, implantable defibrillators, and neurostimulators are classic examples.

Advantages of the service

• Work led by specialists with experience on active implantable devices.
• A certification plan that fits the specific product and its intended use.
• Efficient handling that keeps the file moving.
• International recognition that opens access to EU and wider export markets.

Why certification under the directive matters

90/385/EEC certification is a prerequisite for placing active implantable medical devices on the EU market. Working with Sistem Patent Kalite gives the manufacturer compliance with the directive and a clean route to market. The team supports the manufacturer at each stage of the certification cycle with a customer-focused service.