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  • Apply for over-the-counter certificates for active medical devices

Apply for over-the-counter certificates for active medical devices

  • Unternehmensstart und Gewerbezulassung
  • Auslandsgeschäft 



    	    

		    
Are you responsible for placing a medical device on the market and would like to export it outside the 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 medical devices 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 and Article 10 of Regulation (EU) 2017/745 of a medical device.
  • Only manufacturers and authorized representatives based in Germany can apply here for a certificate of free sale for medical devices.
								    
What documents do I need?
    
    
  • Declaration of Conformity        
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  • Product list        
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  • Certificate(s) from the Notified Body(ies)        
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