MENU menu

Who Can Sell in the USA and the EU Medical Device Markets?


Sales of medical devices in the European or USA medical device market is restricted with many regulatory requirements. Therefore, any manufacturer outside the country’s territory needs the support of a chain of economic operators. These economic operators assist the medical device manufacturer with relevant regulatory representation.


When it comes to selling medical devices in the European Union, the medical device manufacturer should be aware of the following:


In the EU, a foreign manufacturer can be the owner of a CE mark but needs an E.A.R / EU AR (European Union Authorised Representative).

The EAR bears significant regulatory responsibilities, per EU MDR/IVDR Art. 11, as it is liable for defective medical devices along with the foreign manufacturer in case of non-compliance. Therefore, the EAR must verify and keep copies of conformity assessment documents.

Any medical device that enters the EU from a third country needs access to an EU Importer located in any country of the EU single market.

The EU Importer has considerable regulatory responsibilities where registering in the EU-wide Database EUDAMED is a crucial activity. In addition, article 13 of the MDR/IVDR enlist other regulatory responsibilities for the EU importer, including post-market surveillance and compliance verification.

Why take the risk of non-compliance? Connect with our experts now! 

As per the European regulatory needs, a ‘legal manufacturer’ is the one who owns a CE Mark and endorses the commitment towards regulatory compliance.

The  EU MDR Art. 2(30) or IVDR Art. 2(23) defines a Manufacturer as  “a natural or legal person who manufactures or fully refurbishes a device or has a device designed, manufactured or fully refurbished, and markets that device under its name or trademark.”


Additionally, the EU MDR/IVDR Article 16 assumes distributors and importers (or other persons) are the “legal manufacturer” if they sell the device under their name, modify the device’s intended purpose or its characteristics in a manner that affects the applicable requirements.


The scenario for the US market is similar but there are small differences. As a medical device manufacturer entering the US medical device market, you should be aware of :

A foreign manufacturer must appoint a US Agent.

The US Agent has limited responsibilities. The primary role is to act as a liaison agent between the FDA and the foreign establishment. It bears no responsibility related to reporting of adverse events under the Medical Device Reporting regulation (21 CFR Part 803) or submitting 510(k) Premarket Notifications (21 CFR Part 807, Subpart E).

Any medical device that enters the US medical device market from a foreign country needs an Initial Importer located in the US.

Subjecting to establishment registration and all applicable US FDA Laws, the Initial Importer must be staffed by individuals responsible for ensuring the compliance of imported devices.

In the US, irrespective of the subcontracted activities, the manufacturers are the producers. Their role is not linked to the holder of regulatory approvals (unlike the EU).

The US FDA’s 21 CFR 820.3 (o) defines Manufacturers as “any person who designs, manufactures, fabricates, assembles, or processes a finished device. The manufacturer includes but is not limited to those who perform the functions of contract sterilisation, installation, re-labelling, remanufacturing, repacking, or specification development, and initial distributors of foreign entities performing these functions.”


Companies involved in repacking and re-labelling a medical device for US market entry can rely on regulatory approval/clearance obtained by another company.

As a manufacturer, it is essential to understand the differences between the regulatory requirement of the USA and the EU – the top decision-making regulatory differences are:

Read the CE Mark Process Guide here


Avoid the hassle of trying to understand these different regulatory mechanisms by engaging with the specialists at Med-Di-Dia.

Contact us now

Call: +353 (0)91-704804



Read More 




Get access to the Med-Di-Dia’s newsletter, where industry experts help you to stay on top of shifting global markets.

Stay updated with the latest Trends in the world of Medical Devices!


* indicates required