In order to bring medical devices to the European (EU) market, manufacturers must earn a CE Mark to confirm compliance with the Medical Device Directive 93/42/EEC (MDD) and its supplementary Directive 2007/47/EEC; or in the case of in vitro diagnostic medical devices,the In Vitro Diagnostics Directive (IVDD) 98/79/EC.
These CE marking Directives cover active medical electrical equipment, non-active medical devices, and in vitro diagnostic medical devices; all of which are classified according to the potential risks associated with the device. Most device classifications require both accredited testing and Notified Body services in order to gain the necessary market approvals. Eurofins Medical Device Testing operates as a Notified Body authorised to issue EC certifications in accordance with the appropriate CE marking Directive; MDD 93/42/EEC or IVDD 98/79/EC:
Class II active medical electrical equipment and non-active medical devices
All remaining risk shall possibly be in the green region.
In vitro diagnostic medical devices, IVDD Annex II devices and devices for self-testing
EC Type Examination certificates (MDD, Annex III)
EC Verification certificates (MDD, Annex IV)
EC Declaration of Conformity – Production quality assurance (MDD, Annex V)
EC Declaration of Conformity – Product quality assurance (MDD, Annex VI)
EC Declaration of Conformity – Full quality assurance system (Annex II)
EC Declaration of Conformity – Design examination (IVDD, Annex III)
EC Declaration of Conformity – Full quality assurance system (IVDD, Annex IV)
In addition to product compliance, medical device manufacturers have to provide evidence that they have fulfilled the requirements of ISO 13485; a process-oriented, medical device industry- specific, Quality Management System (QMS) standard.
ISO 13485 is a harmonized standard for the directive 93/42/EEC.
Eurofins Medical Device Testing operates as accredited Certification Bodies according to ISO 13485 Quality Management System for Medical Devices. The ISO 13485 is recognized for the quality management systems in the medical devices sector, intended to be used by any organization that deals with the design, development, production, installation and technical assistance of medical devices or services connected to them.
This certification helps the applicant to demonstrate their commitment to the quality management system. It shows responsibility by the company supplying the medical device product or service to conform with the rules; linked through compliance to the applicable standards and customer experience.
ISO 13485:2016 supersedes ISO 13485:2003/Cor 1:2009 and carries with it a number of changes. The transition period ends on 1 st March 2019.
Obtain your ISO 13485 QMS certification through our audit and inspection services.
Maintain your ISO 13485 QMS certification.
Eurofins Medical Device testing services operate as certification bodies n. 133A and n. S021 according to ISO 13485 Scheme; Quality Management System (QMS) for Medical Devices. These certification bodies’ services are through our global network of Eurofins Electrical & Electronics (E&E) laboratories.