Declaration of Conformity

The EU declaration of conformity for medical devices is a document issued by the manufacturer of a medical device. It confirms that the product complies with the requirements of the applicable EU directives or regulations. The declaration of conformity is part of the conformity assessment procedure that ensures that medical devices comply with EU regulations and are safe for use in the European Union.

The specific requirements and procedures for conformity assessment of medical devices are governed by various directives and regulations in the European Union. Prior to 26 May 2021, the main directives were the Medical Devices Directive (MDD) 93/42/EEC, the In-vitro Diagnostic Medical Devices Directive (IVDD) 98/79/EC and the Active Implantable Medical Devices Directive (AIMDD) 90/385/EEC. As of 26 May 2021, these directives have been replaced by new regulations called the Medical Device Regulation (MDR) and the In-vitro Diagnostic Medical Device Regulation (IVDR).

The MDR applies to medical devices, while the IVDR applies to in vitro diagnostic medical devices. These regulations aim to strengthen the regulation of medical devices in the EU and further improve the safety and performance of products.

Our products comply with the standards of the mentioned Medical Device Regulation (MDR). We are happy to provide you with our declarations of conformity as a download.