WELCOME TO AUREPS

AUREPS - your trusted EC Representative and Expert Advisor
We introduce your Medical Device in Europe and maintain your access to the market.

OUR COMMITMENT

AUREPS

  • serves as your Authorised European Representative (EAR)
  • assures your compliance through conformity assessment procedures
  • serves as primary contact to EU Authorities
  • monitors your post-market surveillance including incident reporting
LEGAL REQUIREMENTS

  • Authorized European Representative

    Per Article 14.2 of Council Directive 93/42/EEC as amended by Directive 2007/47/EC, manufacturers, without a registered place of business in the EU, require to designate a single Authorized European Representative (EAR). AUREPS offers to serve as EAR and as of this assists you in meeting your compliance with conformity assessment procedures, serve as primary contact for EU Authorities and support you in incident reporting.

  • Brexit and Authorized Representatives (EAR)

    A manufacturer placing devices on the European market can only do that if that firm is based in the EU, or by using an Authorized Representative (EAR). If the UK leaves the EU, British manufacturers will need an EU-based AR, just like other non-European manufacturers. In other words, the UK will be a “third country.”

    We can only speculate on what the UK requirements will be for non-UK based manufacturers and distributors placing devices on the UK market, and for UK-based manufacturers and distributors placing devices on the EU market. We will focus on the impact of Brexit regarding medical devices and IVDs, but the consequences of Brexit will impact all products covered by any EU regulation or directive listed in the annex of the aforementioned notice.

MISSION

Our mission is to assist our clients in introducing innovative medical technologies to the European market and provide customized product commercialization and distribution models for new product development concepts. Our focus is on medical devices especially in the fields of prosthetic implants, surgery, dental technology, cardio-vascular surgery, neuromonitoring and aesthetic surgery.

PHILOSOPHY

It is this philosophy and dedication to service that has been the paradigm for AUREPS since its founding. AUREPS has successfully represented numerous companies in bringing important, cutting-edge technologies to the EU market. 


Our experienced team develops customized strategies and support for innovative companies, which intend to successfully launch their products to the European Market.