What is a Declaration of Conformity (DoC)? Please contact us to learn more about our CE Technical Documentation preparation services for medical devices and IVD manufacturers. Review your proposed labeling and Instructions for Use.Review your clinical data, compile a Clinical Evaluation Report (CER), and facilitate a Risk Assessment as necessary.Determine applicable testing requirements and standards for your device.Compile your EU Technical Documentation, with internal peer review.Evaluate and identify gaps or deficiencies in your documentation. Completely review all existing documentation in support of meeting the applicable Essential Requirements of the Directive(s).Help you determine exactly which materials need to be compiled.
Here's a checklist of the services we provide: Emergo offers CE Technical Documentation compilation servicesĮmergo specializes in helping medical device and IVD companies achieve CE Marking certification, and we have done so for thousands of devices. Understanding how to assemble this information and present it for review by Notified Bodies is essential. Unless you manufacture a Class I device that is not provided sterile and does not have a measuring function, your Technical Documentation must be reviewed by a Notified Body. They are required for all classes of devices (Class I, I Measuring, I Sterile, IIa, IIb, and III), but no two files are the same because the type of device dictates the information included therein. Your technical documentation includes detailed information about the design, function, composition, use, claims, and clinical evaluation of your medical device. CE Technical Documentation Requirements for medical device companies Emergo can assist medical device and IVD manufacturers transition to meet MDR and IVDR requirements for Technical Documentation.
These requirements have changed from those under the European Union's previous Directives-the Medical Devices Directive (MDD) 93/42/EEC, the Active Implantable Medical Devices Directive (AIMDD) 90/385/EEC and the In Vitro Diagnostic Medical Devices Directive (IVDD) 98/79/EC. Compiling your technical documentation is a critical step in Europe's CE Marking process and a requirement for compliance with the Medical Devices Regulation (EU MDR 2017/745) and the In-Vitro Diagnostic Medical Devices Regulation (EU IVDR 2017/746).
How does MDR 2017/745 change EU Technical Documentation requirements?Ī CE Marking Technical Documentation (for high-risk Class III devices) is a comprehensive description of your device intended to demonstrate compliance with European regulatory requirements.What is the proper format for Technical Documentation?.Which device classes require Technical Documentation?.
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