Entry into further markets made possible! Approval of medical devices for sale or distribution in the European Economic Area.
As of May 26, 2021, the EU Regulation 2017/745 (MDR) has been established to replace the old EU directive on medical devices (93/42/EEC). In terms of content, the MDR differs significantly from the previous EU directives in many aspects. Among the important innovations are the expansion of the scope of application, the specification of minimum content for the creation and maintenance of technical documentation, and the tightening of requirements for clinical evaluation. Additionally, new classification rules have been introduced, including a new class classification for reusable surgical instruments, as well as devices that include software and nanomaterials. [Changes to Regulation (EU) 2017/745 for Medical Device Manufacturers (Partial)] ■ Expansion of the scope of application ■ Specification of minimum content for the creation and maintenance of technical documentation ■ Tightening of requirements for clinical evaluation ■ Introduction of new management procedures for high-risk medical devices ■ Appointment of a person responsible for regulatory compliance (PRRC) ■ Strengthening of requirements for post-market surveillance of medical devices *For more details, please refer to the related links or feel free to contact us.
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Certification Process Based on MDR (EU) 2017/745 ■ Information Exchange ■ Preliminary Evaluation ■ Application ■ Review and Acceptance of Application ■ Evaluation of Technical Documentation and Audit of Quality Management System (QMS Audit) ■ Certification Decision ■ Continuation of Certification Cycle *For more details, please refer to the related links or feel free to contact us.*
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【Purpose】 ■Legal requirements in the EU economic area ■Emphasizing the capabilities of the company ■Proving compliance with top-class product standards ■The CE mark enables entry into additional markets *For more details, please refer to the related links or feel free to contact us.
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DQS Japan is a specialized organization with a headquarters in Germany and over 30 years of experience. As a partner to Japanese medical device manufacturers, we provide medical device certification services for both Japan and Europe. In Japan, we operate as a registered certification body, conducting certification for highly controlled medical devices and controlled medical devices. For Europe, we serve as the contact point for DQS Medizinprodukte (DQS Medical Devices), which is a Notified Body under the MDR.