Medical Devices Directive: Product Safety and Quality

Sistem Patent Kalite provides services related to the Medical Devices Directive across design, certification, and market access.

What is the Medical Devices Directive?

The Medical Devices Directive is the EU framework that sets safety and quality requirements for medical devices placed on the European market. It covers products across classes, with requirements that scale with device risk.

How the Medical Devices Directive applies

Compliance with the directive covers design, manufacturing, distribution, and use. The core steps include:

• Product design: Medical devices are designed to the intended use and the specific requirements that apply. The intended purpose and use are defined in detail at this stage.
• Manufacturing process: Production runs against defined standards and quality control procedures. Manufacturing sites are audited on a regular cycle.
• Distribution and use: Products are distributed correctly, with training and guidance for the end user.
• Certification and surveillance: Product conformity is certified by an independent assessment body, and products are tracked through market surveillance.

Which products the directive covers

The directive covers many categories of medical devices:

• Drug injectors
• Prostheses
• Medical imaging devices
• Laboratory equipment
• Dental implants
• Surgical instruments

The directive sets different requirements based on the device classification and its risk level.

How Sistem Patent Kalite supports compliance

The team helps clients on four core activities:

• Aligning product design and manufacturing with the directive's requirements
• Establishing a quality management system and completing the certification
• Supporting the CE marking route for the product
• Managing product surveillance and safety audits

Working with Sistem Patent Kalite gives medical device manufacturers the support they need to secure conformity and reach the market. Contact the team to discuss a specific product and its route.