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e-mail : info@qusmed.com
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FAQ – Frequently Asked Questions
What exactly does an EU Authorised Representative (EC-Rep) do?
An EU Authorised Representative represents manufacturers based outside the EU in dealings with European authorities. They are required to take on specific responsibilities – e.g. providing technical documentation, cooperating with authorities, and reporting incidents.
In short: no legal market access in the EU without an EC-Rep – regardless of the product class.
As a manufacturer based in Germany, do I even need an EU Authorised Representative?
No – as a manufacturer based within the EU, you do not need an EC-Rep. Our services are specifically tailored for manufacturers located outside the European Union.
However, if you represent a supplier, OEM, or private label partner outside the EU, QUSMED could be relevant as an authorised representative.
How quickly can QUSMED act as my EU representative?
Usually within 3–7 business days, depending on the scope of your documentation. We begin after a short onboarding call, contract signing, and a basic review of your documents.
In urgent cases (e.g. upcoming product registration), express solutions are available.
What sets QUSMED apart from other providers?
We are not a broker or an online platform. You’ll have a dedicated contact who understands your industry, actively reviews your documents, and supports you with authority queries.
Legal certainty is not just a checkbox for us – it’s our principle.
What responsibilities do I retain as the manufacturer – despite the EC-Rep?
The EU Authorised Representative formally represents you, but the manufacturer remains responsible. We help you fulfill your obligations correctly and efficiently – not shift them.
Our task: identify risks, close gaps, and reliably manage communication with authorities.
Can QUSMED also help with technical documentation or UDI support?
Yes – we review your documents for completeness, provide gap analyses, checklists, and guidance for optimization. We focus on MDR- and ISO-compliant structure – practical and without unnecessary formalities.
Are there any hidden costs or additional fees?
No. You will receive a transparent offer in advance, covering our role as EC-Rep, document review, and any additional services (e.g. communication with authorities).
No annual fee without clear services. No surprises.
Which product classes do you support?
We support manufacturers of all classes:
- Class I to III
- Software as a Medical Device (SaMD) IVD products under the IVDR
Our experience ranges from digital start-ups to international device manufacturers.
What does the onboarding with QUSMED look like?
The onboarding with QuSmed:
- Schedule an initial consultation
- Receive offer & sign contract
- Document review & registration
- Long-term support as EC-Rep & contact partner