Hpra Medical Devices

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Medical Devices - HPRA

https://www.hpra.ie/homepage/medical-devices

The HPRA for: Patients & Public Healthcare Professionals Industry Philips Ventilators Vaginal Mesh Implants AEDs Publications and Forms Login to Extranets Register for Alerts Consumer advice We have published helpful advice and information for consumers on a …

Clinical investigations for medical devices in Ireland - HPRA

https://www.hpra.ie/homepage/medical-devices/regulatory-information/medical-devices-regulation/clinical-investigations

Medical Devices Regulation. MDR transitional provisions; Qualification and classification ; Clinical investigations. Reprocessing of single-use devices; Drug-device consultations; …

Guide for Distributors of Medical Devices - HPRA

https://www.hpra.ie/homepage/about-us/publications-forms/guidance-documents/item?id=b3760a26-9782-6eee-9b55-ff00008c97d0

The objective of the Health Products Regulatory Authority is to ensure in so far as possible, consistent with current medical and scientific knowledge, the quality, safety and …

Irelands HPRA's: Medical Device Guide to Clinical Investigations ...

https://www.regulatoryaffairsnews.com/post/irelands-hpra-s-medical-device-guide-to-clinical-investigations-carried-out-in-ireland

As part of this guide, the Health Products Regulatory Authority provides guidance on the legislation on clinical investigations using medical devices as well as …

The Notified Body Opinion - European Medicines …

https://www.ema.europa.eu/en/documents/presentation/presentation-notified-body-opinion-assessors-view-maeve-lally_en.pdf

Product 1 –Medicinal product dossier overview (eCTD) Product 1 –Biological (NAS) in PFS, combined with either safety syringe (SS) or auto-injector (AI)Location of device …

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