Free sale certificates for Medical devices, In-vitro diagnostic Medical devices, Supplements and Cosmetics in EU member countries

What are the options for non-registered manufacturers in EU member countries?

For Manufacturers not yet established in one of the EU Member States, they may authorize a representative on their behalf to carry out the registration procedures for issuing a Free Sale Certificate for their products. Article 11 of the MDR 2017/745 and IVDR 2017/746 states: “Where the manufacturer of a device is not established in a Member State, the device may only be placed on the Union market if the manufacturer designates a sole authorised representative.”
Brilitas shall work with the Ministries of Health of EU Member States to implement licensing procedures for manufacturers within and outside the EU. By approving a free sale certificate by the Ministry of Health from a member country of the EU, your product will be circulated in the countries of the European Union system.

Is a free sale certificate a mandatory document?

A free sale certificate is a type of certificate issued by the Ministry of Health of the Member States of the EU in order for Manufacturers, Importers, Exporters to prove to the Health Ministries of non-EU countries that the product is currently free in circulation in the EU market and that there are no administrative actions of the Health Regulatory Authority in the EU regarding the product, such as revocation of the license, forced withdrawal of the product from the market, or forced destruction of the product. This is clearly expressed in the provisions of the European Commission, in particular Article 60 MDR 2017/745 and Article 55 IVDR 2017/746, namely: “For the purpose of export and upon request by a manufacturer or an authorised representative, the Member State in which the manufacturer or the authorised representative has its registered place of business shall issue a certificate of free sale declaring that the manufacturer or the authorised representative, as applicable, has its registered place of business on its territory and that the device in question bearing the CE marking in accordance with this Regulation may be marketed in the Union.”
It should be noted that a free sale certificate issued by the Ministry of Health of the EU Member States is very valuable when registering products in the countries of Asia, Africa, America, and Australia.