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.

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.

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.

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.

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.

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.

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.

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.