OverviewClass 1 Medical Devices 21 CFR Part 11 NAKI - The German National Working GroupThe National Working Group (NAKI) was created to answer questions on the implementation of the EU regulations, the MDR and the IVDR.Accessories for Medical DevicesMedical devices accessories have to meet the same regulatory requirements as the medical device. However, there are differences, manufacturers should be aware of.Declaration of Conformity Design input Design ChangeA design change may require a re-approval respectively re-submission. There are many regulatory requirements related to design changes. Essential RequirementsMedical devices have to fulfill the "essential requirements" laid down in the medical device directive respectively the "general safety and performance requirements" laid down in the medical device regulations. Get an fast overview here!GDPR EUDAMEDEUDAMED, European Database on Medical Devices, is introduced by the Medical Device Regulation MDR. In stores data about medical devices, clinical evaluations etc.Free Sales CertificatesMany countries insist on Free Sales Certicates (FSCs) to clear medical devices. wWat FSCs are, how to obtain certificates, by whom, and at which costs Harmonized Standards IVD SoftwareIVD Software is standalone Software that is classified as IVD. Learn how to classify and develop the software compliant with IVDR and other regulations.Laboratory Developed TestsThe Laboratory Developed Tests LDT will be strongly regulated by the IVDR and FDA. the requirements are comparable to regular invitro diagnostic devices.MDR Rule 11 (Software)MDR's classification rule 11 is a nightmare: It will be a major issue for manufacturers of medical device software. Read what's new and why the EU commission needs to act.MEDDEV Documents Notified BodiesMedical device manufacturers have to involve for approval processes notified bodies. These are companies that evaluate and certify quality management systems on behalf of national authorities. Periodic Safety Update Report PSURThe MDR and IVDR require a Periodic Safety Update Report (PSUR) or a Post-Market-Surveillance Report. Tips for implementation!Post-Market SurveillanceRegulatory Requirements and Tips for Procedural Instructions considering Post-Market Surveillance, Market Surveillance and Vigilance.Premarket Approval (510k) Systems & Procedure PacksMDR and MDD have different(!) requirements with respect to system and procedure packs. When a conformity assessment procedure is required...Technical File versus DHFThe FDA requires in 21 CFR part 820.30 a design history file (DHF). These is part of the technical documentation, sometimes also referred to as device master record DMR.Unique Device IdentificationThe MDR requires a Unique Device Identification for medical devices. It consists of a device identifier (UDI-DI) and a production identifier (UDI-DI). Physiological processesIt is important to understand what is a vital physiological processes since the classification rules of MDD and MDR depend on this definition.
