News Category: Regulatory news
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.