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:
- Local Representative – EU Authorised Representative
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.
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 :
- Local Representative
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:
- If you are a US medical device Manufacturer with USFDA 510(k) clearance - you will be treated as a ‘legal manufacturer’ in the USA but not in the EU. To sell your product in the EU, you will require a CE Mark and an EU Authorised Representative.
- If you are a US private labeller or distributor who has re-packaged/re-labelled someone else’s medical device, you would be seen as the “legal manufacturer” in the EU and you will need to appoint an EU Authorised Representative.
- If you are an EU private labeller wanting to sell a device from the original manufacturer in the US, you could rely on the US FDA’s clearance/approval obtained by the original manufacturer. You would be considered a foreign re-labeller/re-packager.
Avoid the hassle of trying to understand these different regulatory mechanisms by engaging with the specialists at Med-Di-Dia.
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