Irish competent authority publishes guide for distributors of medical devices
Posted on 05.03.2018
The Irish Health Products Regulatory Authority, HPRA published a Guide for distributors of medical devices in February 2018.
The document aims to provide supplementary guidance and recommendations for best practices to distributors acting in Ireland taking into account the obligations for medical device including in vitro diagnostic medical device distributors in the IVD and MD Regulations.
In order to meet the legislative requirements and to ensure that only medical devices that comply with the legislation are made available for supply, the guide recommends for distributors to have a quality system in place. It is particularly important that Standard operating procedures (SOPs) relating to activities in certain areas (e.g. receipt of material at the goods inwards area) are available to staff in the relevant area for reference as required. In addition, there should be procedures in place for:
- Documentation control
- Approval of suppliers and customers
- Order processing and deliveries
- Waste management
- Change control
- Management review
- Quality risk management
- Management of Field Safety Corrective Actions/recalls
- Non-conformance management
- Corrective and preventive actions
Additional obligations apply to distributors who also function as importers into the European Union.