Відео

Placing Custom-Made Devices on the Market

Custom-Made Device Manufacturer Requirements under MDR

Custom-Made Devices - demonstrating regulatory compliance

Complaints and Reporting to the Competent Authority - Post-Market Surveillance and Vigilance

Questions and Answers session

Our Medical Devices team recently presented at a webinar hosted by the National Clinical Pathology Programme on in-house in-vitro diagnostic medical devices (IVDs). The presentation provided insights into the requirements for health institutions who manufacture and use in-house IVDs in Ireland.

Níl aon dearbhuithe ag tomhaltóirí maidir le sábháilteacht nó cáilíocht na gcógas ar oideas a cheanaíonn siad lasmuigh den suíomh cógaisíochta rialaithe. Is baol do do shláinte é cógais ar oideas a cheannach ar líne.

How to report an adverse event using the online reporting form

The role of animal owners in monitoring the safety and effectiveness of veterinary medicines

Adverse event reporting for vets, vet nurses and animal healthcare professionals

I got sicker!

You won't believe what they sent me

Cleaning Validation

Registration requirements and certificates of free sale

Performance studies

HPRA IVD inspection activities

Post - market surveillance, vigilance and market surveillance

European and national implementation of the IVDR

Annex 21 - Importation of medicinal products

Out-of-specification (OOS) investigations

Management of outsourced activities and QP responsibilities

HPRA quality defects and recall (QDR) programme

Overview of GMP inspections, 2018 2021

Key updates of interest

Safety features update

Deficiency trending

Temperature mapping

Transport and outsourced activities

Clinical Trial Regulation: Post-authorisation, transition and how can I prepare