Related Regulations, Schemes and Standards

Some regulations, standards and schemes relating to medical devices

Standards we certify

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In Vitro Diagnostic Device Regulation (IVDR)

The ln Vitro Diagnostic Device Regulation (IVDR) is a new regulation that will replace the existing ln Vitro Diagnostic Devices Directive (IVDD) 98/79/EC. It applies to all IVD manufacturers who intend to place their products in the European Union (EU).

ISO 13485:2016

ISO 13485:2016 (Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes) is the international standard that defines Quality Management Systems (QMS) requirements for organisations that design, develop, manufacture, install and service medical devices and design, develop, and provide related services, including manufacturers of materials or component parts that are used in medical devices.

Medical Device Regulation (MDR)

The Medical Device Regulation (MDR) is a new regulation that will replace the existing Medical Device Directive (MDD) 93/42/EEC and Active Implantable Medical Devices (AIMD) Directive 90/385/EEC. It applies to all medical device manufacturers who intend to place their products in the European Union (EU).

Medical Device Single Audit Program (MDSAP)

The MDSAP is a harmonised approach to auditing and monitoring the manufacturing of medical devices developed by the International Medical Device Regulators Forum (IMDRF). This global approach opens possibilities and pathways to support the development of a worldwide initiative of countries dedicated to pooling technology, resources, and services to improve the safety and oversight of medical devices on an international scale.