In February 2018, the Health Products Regulation Authority (HPRA) published a comprehensive guide in relation to the obligations of distributors of medical devices. You can access the guide here.
This guide has been published on foot of Regulation 2017/745 on medical devices and Regulation 2017/746 on in vitro diagnostic devices (the "New Regulations"). The New Regulations entered into force on 25 May 2017, but have staggered transitional periods.
The New Regulations impose considerable extra obligations on all operators in the supply chain of medical devices and on distributors in particular. The guide sets out, in a very useful table, the obligations that apply to distributors in respect of medical devices including those in respect of:
- Acting with due care;
- Ensuring conformance with CE marking requirements;
- Applying a unique device identifier to medical devices;
- Complying with storage and transport conditions of medical devices as set by the manufacturer;
- Notifying the manufacturer or Member States in respect of devices which do not conform with the New Regulations;
- Handling of complaints regarding devices and record keeping in respect of such complaints;
- Ensuring traceability of devices; and
- Identifying economic operators and health institutions/healthcare professionals who have been supplied with a device.
Very helpfully, the guide also sets out the circumstances in which the obligations of manufacturers will apply to distributors.
Finally, there is considerable guidance provided to distributors as to how they can ensure compliance with the New Regulations. The guide recommends that all distributors of medical devices have a quality system in place and that standard operating procedures are put in place by distributors.
This guide is a "must read" for all distributors of medical devices and our Regulatory team is on hand to provide advice in respect of the New Regulations.
Contributed by Sarah Power