ISO 13485:2016 MD-QMS – Catering the needs of Non-Active Medical Devices

ISO 13485 Certification outlines the framework for organisations to provide high-quality medical equipment to satisfy consumers, clients, and stakeholders. Organisations engaged in one or more phases of the life cycle of a medical device, such as design, development, production, storage, distribution, installation, and technical support, should take note of this accreditation.


The MD-QMS requires external parties and suppliers to provide top-notch goods and services to guarantee the safety and well-being of clients and customers.

What is Non-Active Medical Devices?

Non-Active Medical Devices form part of the Main Technical Areas under ISO 13485:2016 Certification. Moreover, Main Technical Areas are divided into five categories; these are :-

  1. General Non-Active, Non-Implantable Medical Devices

Non-active medical devices do not rely on an external energy source for operation. These devices are crucial in healthcare settings and necessitate thorough testing to ensure user safety and intended functionality.

It includes:

  • Non-active devices for emergency, anaesthesia and intensive care
  • Non-active devices for injection, transfusion, infusion and dialysis
  • Non-active medical devices with measuring function
  • Non-active ophthalmologic devices
  • Non-active medical devices for disinfecting, cleaning and rinsing
  1. Non-Active Implants

Inactive implants encompass various types, such as non-active cardiovascular, orthopaedic, functional, and soft tissue implants. Moreover, these implants are not used for permanent placement within the human body.

It includes:

  • Non-active cardiovascular implants
  • Non-active orthopaedic implants
  • Non-active functional implants
  • Non-active soft tissue implants
  1. Devices for Wound Care

Wound care medical devices assist in dressing wounds. They encompass materials such as cotton wool, bandages, gauze dressings, sutures for closing dermal wounds lasting less than 30 days, and surgical gloves. These devices do not contain antimicrobial agents and do not utilize animal tissues.

It includes:

  • Wound dressings and bandages
  • Clamps and suture material
  • Other medical devices for wound care
  1. Non-Active Dental Devices and Accessories

Non-active dental devices and accessories encompass various dental instruments and equipment, ranging from X-ray cones to face bows. Additionally, this category includes dental materials and implants.

  • Non-active dental instruments and equipment
  • Dental materials
  • Dental implants
  1. Non-Active Medical Devices other than Specified Above


The ISO 13485:2016 certification outlines further prerequisites tailored for the healthcare and medical device sectors to address heightened risks and safety concerns for patients. However, this certification applies to organizations, offering detailed guidelines for establishing, monitoring, and managing quality management systems to regulate processes and services effectively.