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  • Apply for over-the-counter certificates for active in vitro diagnostics

Apply for over-the-counter certificates for active in vitro diagnostics

  • Unternehmensstart und Gewerbezulassung
  • Auslandsgeschäft 



    	    

		    
Are you responsible for placing an in-vitro diagnostic device on the market and would like to export it outside the European Union? Then the respective competent authority will issue a certificate according to §10 MPDG upon your request.

		    


                					    

						    

							    Competent Department
						    

						    
					    

                        
					    

						    

							    Basic information
						    

						    

							    

								    
As a manufacturer of in vitro diagnostics or its authorized representative, you can apply for the issuance of a certificate of free sale for export purposes. The certificate of free sale confirms that the manufacturer or authorized representative has its registered office in Germany and that the product in question can be traded within the Union.

								    

									    Requirements
  • Product must be placed on the market according to Article 5 Article 10 of Regulation (EU) 2017/746 of an in vitro diagnostic medical device.
  • Only manufacturers and authorized representatives based in Germany can apply here for a certificate of free sale for in vitro diagnostic medical devices