Applying for a certificate of free sale – updated information

News Category: Regulatory news

Date: 04/11/2021

The HPRA has published updated information relating to export certification, including information about applying for a certificate of free sale for medical devices.

In this update, the HPRA has:

  • Provided an overview of the legal basis for issuing certificates of free sale;

  • Clarified the process for applying for certificates of free sale under Directive 93/42/EEC (MDD) and Regulation 2017/745 (MDR);

  • Developed a checklist to assist stakeholders when applying for a certificate of free sale.  

To view these updates in more detail please visit the Export Certificate webpage. The page also includes a link to the HPRA’s updated guide to Applications for Certificates of Free Sale for Medical Devices.


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