Regulation on Active Implantable Medical Devices

What is the Active Implantable Medical Devices regulation?

The Active Implantable Medical Devices regulation is the European Union framework that covers the design, manufacture, and marketing of medical devices implanted in the human body. The regulation is designed to keep these devices safe and effective for patients across their full life cycle.

How certification under the regulation is obtained

Compliance with the regulation covers the product from design through manufacture, distribution, and use. The core steps include:

• Product design: Devices are designed to be compatible with the human body and safe in use. Design and performance are assessed in detail.
• Manufacturing process: Production sites operate under defined standards and quality control procedures. Traceability and recall procedures are set up.
• Certification and surveillance: Product conformity is certified by an independent assessment body. Products are then tracked through market surveillance and updated where necessary.

Which products the regulation covers

The regulation applies to several categories of active implantable medical devices:

• Pacemakers
• Hip prostheses
• Intraocular lenses
• Cochlear implants

Other implanted electronic devices

These devices go through a long and detailed assessment and must meet the specific requirements the regulation sets.

How Sistem Patent Kalite supports compliance

Sistem Patent Kalite has a specialist team for Active Implantable Medical Devices compliance. The service covers four core areas:

• Aligning product design and manufacturing with the regulation's requirements
• Managing the certification process end to process
• Managing product surveillance and recall procedures
• Tracking market surveillance and regulatory updates