In-Vitro Diagnostic Devices
Welcome to MDSS In-Vitro Diagnostic Medical Device Division
MDSS's Medical Device Industry experts are trained to assist you with In-Vitro Diagnostic Device Standards. MDSS is there when you need an Authorized Representative who can represent your company with your best Regulatory Affairs interests in mind for your In-Vitro Diagnostic Device.Please avail yourself of the information offered in all the areas of our website. Take a self guided tour to learn why you can rely on MDSS for IVDD, and understand what MDSS can do for you and why you need MDSS as your "Authorized Representative" in the European marketplace for In-Vitro Medical Devices, Medical Devices and Active Implantable Medical Devices.
- Know the facts
- The legal & safety aspects of selecting an Authorized Representative & why not to appoint a distributor
- Harmonized Standards
- The lists of harmonized standards applicable to IVDD 98/79/EC
- The lists of harmonized standards applicable to IVDD 98/79/EC
- EDMA-Code (European Diagnostic Manufacturer Association)