EU Representation

EUDAMED Registration Services

Check Check

EU Authorized Representative (EU REP) Services

Manufacturers located outside the European Union must appoint a European Authorized Representative (EU REP) to place medical devices on the EU market in accordance with Regulation (EU) 2017/745 (EU MDR).

The EU REP acts as the official liaison between the non-EU manufacturer and European regulatory authorities.

Our EU REP Services Include:

  • Acting as your legally designated EU Authorized Representative

  • Registration in EUDAMED and obtaining SRN

  • Competent Authority registration or change of registration from one member state (country) to another

  • Verification of Technical Documentation and EU Declaration of Conformity

  • Communication with Competent Authorities

  • Support in vigilance reporting and post-market surveillance

  • Maintenance of regulatory documentation records

  • Assistance during inspections and audits

With our structured compliance approach and regulatory expertise, we ensure your products remain fully compliant and continuously supported within the European market.

INDIA

Puthiyaveetil, Parampuzha, Kottayam, Kerala – 686004, INDIA
qmserviceindia@gmail.com  |  ceo@qmserviceindia.com
www.qmserviceindia.com
91-9061033526, 91-9349208199, 91-8075108926
info@qmserviceglobal.com   |   www.qmserviceglobal.com

EUROPE

Bureau Medica Intercert DK
Kaj Sommers Vej 6, 3320 Skævinge – Denmark
SRN: DK-AR-000043850
www.bureaumedica.com
info@bureaumedica.com