medicines-medical devices-regulatory affairs
Issue 76 (February 2024) of the HPRA Medicinal Products Newsletter has been published. As usual, it is packed with information and includes (but is not restricted to) the following information: 1) Clinical trials applications – Important dates and information Applicants…
Notification of a clinical investigation under Article 82 MDR Clinical investigations of medical devices that are not performed for any of the purposes listed in Article 62 (1) or Article 74 of the MDR require notification to the HPRA under…
The HPRA, Ireland has provided updated information on its website concerning the national position on Article 17 of the Medical Device Regulation (EU) 2017/745 (MDR) and the reprocessing of single-use devices (SUDs). What is a single-use device? A ‘single-use device’…