Requests may be submitted from companies to the Compliance Department of the IMB for certificates of free sale for export purposes for:
- General medical device(s)
- Active implantable medical device(s)
- In-vitro diagnostic medical device(s) (IVD's)
There are three types of certificates of free sale. They are issued with reference to one of the above categories. Each certificate of free sale is issued in respect of a specified medical device product or products. The content will vary depending on whether the devices are CE marked or not and whether the applicant is a manufacturer or an authorised representative.
Certificates of free sale can only be issued where proof of manufacture is provided for the products concerned and the manufacturer, authorised representative or legal manufacturer is located in Ireland and if applicable, is certified to manufacture products with a CE mark.
The IMB Guide to Applications for Certificates of Free Sale for Medical Devices outlines the information and documentation required when making an application for certificates of free sale. Information and assistance can be obtained from the IMB and the contact details are included in this document. The relevant application form is Application for certificates of free sale for medical devices.
All applications should be emailed to the IMB Compliance Department at email@example.com.