On 4 April 2017, the Health Products Regulatory Authority ("HPRA") published for consultation a draft guide to distribution of medical devices and in vitro diagnostic medical devices ("Guide"). The draft Guide is intended to provide guidance to industry with a view to the adoption of the forthcoming EU Medical Device Regulations.
The draft Guide includes supplementary guidance to distributors by setting out the HPRA's recommendations for good distribution practice and other considerations for distributors of medical devices. One of the principal recommendations put forward in the draft Guide is to ensure that distributors have a quality system in place that covers, amongst others, the following:
- Quality management;
- Personnel and staff training;
- Documentation and record keeping;
- Receipt, storage and supply;
- Returned medical devices;
- Falsified medical devices;
- Outsourced activities;
- Transport; and
Further guidance on each of the above topics can be found in the draft Guide. Interested stakeholders have until 19 May 2017 to submit their comments and can do so by e-mail to distributionconsultation@hpra or by posting them to the HPRA.
Further details on the consultation can be found on the HPRA website.
This article contains a general summary of developments and is not a complete or definitive statement of the law. Specific legal advice should be obtained where appropriate.