CE Marking (Europe)
CE Marking related services for medical devices
In order to export medical devices to the European markets, CE markings must be affixed to products in line with the requirements set out in European Directives, the legislative acts of the European Union. The CE marking is a proof that the item meets the relevant European Union legislations. Once granted with a CE mark, you can distribute or sell the product in the European Economic Area without additional regulations by member states. Depending on the type of medical devices, you must select an appropriate directive from the Medical Device Directive (MDD: 93/42/EEC), Active Implantable Medical Device Directive (AIMD: 90/385/EEC) or the In Vitro Diagnostic Device Directive (IVDD: 98/79/EC) to which to make your product conform to.
TÜV-SÜD Product Service (in Munich, Germany) is accredited as a Notified Body for all of these directives by the German accreditation organization, ZLG and provides CE certification services. In Japan, Quality Management System Certification and Type Test required by the EU directives are provided through MHS Department of TÜV-SÜD Japan.
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Professional experts within the TÜV-SÜD Group can offer services to accommodate to a wide variety of medical devices including Active/non-active medical devices and IVDs. TÜV-SÜD Japan provides CE marking assessment in Japanese for most medical devices. For the assessments of certain products, an expert may be invited from overseas.
The TÜV-SÜD Group is not only a certification organization for the ISO 13485 and ISO 9001, but it is also accredited as an assessment organization for other regulations of major countries and regions, such as the Canadian Medical Devices Regulation and the Japanese Pharmaceutical Affairs Law, enabling customers to obtain certifications of other standards or regulations at the same time as obtaining CE certification.
Many customers have chosen us to obtain CE marking, mostly for the MDD and the IVDD. When considering exporting medical devices/IVDs to the European market, please contact TÜV-SÜD Japan.
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TÜV-SÜD Infoservice provides many seminars in addition to the ones mentioned above. For more details, please click the link to go to the page for TÜV-SÜD Infoservice.