MARKET REPRESENTATION
Manufacturers located outside the EU or UK are legally required to appoint an authorised representative to place medical devices on these markets.
Yousfis EU acts as an EU and UK authorised representative, ensuring regulatory obligations are met and communication with authorities is managed professionally and responsibly.
Professional EU authorised representative services meeting all MDR regulatory obligations and manufacturer responsibilities.
UK responsible person services ensuring compliance with UK MDR requirements for medical devices placed on the UK market.
Professional communication and liaison with EU and UK competent authorities on behalf of manufacturers.
Support with incident reporting, field safety corrective actions (FSCAs), and vigilance reporting to regulatory authorities.
Ensuring required documentation is available to competent authorities and maintaining regulatory compliance oversight.
We take this role seriously and operate with a strong focus on regulatory responsibility and transparency.
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