As a CE 2797 and CE 0086 Notified Body under the Medical Device Regulation MDR, BSI has the technical expertise and experience to provide CE Marking services.
Gain entry to the European medical device market with mdi Europa as your well trusted EU Authorized Representative!
Medical device CE markingMedical Device CE marking For more than 20 years, CEpartner4U has been a valued partner of hundreds of organizations worldwide. Our services range from regulatory strategy and compliance to clinical evaluation, authorized representation (EC REP), and training....
获得医疗器械CE认证,进入欧盟市场 CE marking medical devicesCE标记可证明医疗器械制造商生产的产品符合欧盟所有医疗器械相关指令或法规的基本要求。这些指令或法规概述了欧盟对医疗器械产品的安全和性能要求。CE认证是欧盟对医疗器械产品上市的法律要求。 如何获得CE标志? CE标志是医疗制造商对其产品符合相应法规要求的声明。
CE标志永久被接受仅适用于DBT部门管辖的产品,不适用于MHRA管辖的医疗器械和体外诊断医疗器械。医疗器械和体外诊断器械制造商仍然应根据MHRA相关规定进行合格评定(适用时)和注册程序。 DBT管辖产品进入英国市场 …
Background CE marking, granted by a notified body, is required for most implantable medical devices (IMD), except custom-made IMD and those intended for clinical investigations, before being placed on the market. IMD granted a CE marking are certified to comply with the essential requirements of...
Medical Device Market Approval and Certification Energy-related Products (ERP) Directive ENEC and ENEC+ Certification Geprüfte Sicherheit (GS) Mark RoHS 2 Toy Safety Directive WEEE II Directive CE MARKING TRAINING TÜV SÜD Academy in the UK also offersCE Marking trainingwhich is aimed at anyone...
Medical devices Unmanned aircraft systems But there is a special district in GB that still uses CE marking, which is Northern Ireland. The UK government has a special marking-UKNI marking for the products sold in the Northern Ireland market. The following part will explain it in detail. ...
Active Implantable Medical Devices In-vitro Diagnostic Medical Devices Benefits of CE marking with BSI BSI The Netherlands (2797) is a full-scope Notified Body designated for all three types of devices under MDR and IVDR As a manufacturer, this simplifies the certification of your medical devices ...
World leading Wellkang group offer UK & EEA (EU/EC) European authorised/authorized representative (UK Responsible Person) & CE Mark (CE Marking) consulting services for medical devices MDD, low voltage electrical equipment LVD, cosmetics, EMC, PPE.