ASSESSING THE COMPLIANCE OF ELECTRICAL MEDICAL DEVICES REGULATORY FRAMEWORK

LCIE BUREAU VERITAS ASSESSING THE COMPLIANCE OF ELECTRICAL MEDICAL DEVICES REGULATORY FRAMEWORK The European market is becoming more regulated and more controlled. To be sold in Europe, medical devices have to comply with the requirements of the following... More

LCIE BUREAU VERITAS ASSESSING THE COMPLIANCE OF ELECTRICAL MEDICAL DEVICES REGULATORY FRAMEWORK The European market is becoming more regulated and more controlled. To be sold in Europe, medical devices have to comply with the requirements of the following Directives: Directive 93/42/EC (amended in 2007) related to Medical Devices Directive 90/385/EC related to Active Implantable Medical Devices (AIMD) Directive 98/79/EC related to In Vitro Diagnostic Medical Devices (IVDMD) Depending on the device’s characteristics, other Directives might apply: RED 2014/53/UE (previously R&TTE 1999/5/EC) RoHS 2011/65/UE YOUR RESPONSIBILITIES The company placing the product on the EU market should: Create and update the medical device’s technical file, including relevant test reports Create and update compulsory processes If necessary, obtain the ISO 13485 certification for the management of the quality system NOS SOLUTIONS POUR VOUS ACCOMPAGNER Accréditation COFRAC Essais REGULATORY WATCH Accredited N Less