European Business Consultants
MDR
Background
MDR or Medical Devices Registration, Compliances required for distribution of products in EU
With the implementation of the EU Medical Device Regulation (MDR 2017/745), manufacturers face complex and evolving regulatory requirements. Our consultancy was established to guide medical device companies through this rigorous framework, ensuring full compliance and market access
Being based in the EU allows us to maintain direct relationships with Notified Bodies, Competent Authorities, and other key regulatory stakeholders. This proximity enables faster communication, better insights into current expectations, and timely support for clients during audits and conformity assessments.
The EU is the second-largest medical device market in the world. By operating within this environment, we position ourselves at the heart of regulatory developments and industry trends, giving our clients a competitive edge.
Case Study
The Problem
Class I Manufacturer in India Wants To Enter EU
Manufacturer has no entity in the EU and neither they want to spend time and money to create a new EU entity
Manufacturer has CDSCO compliance in India but same standard are not accepted in the EU
Our Solutions
Cosmo Enterprises is appointed as an authorized representative in the EU hence enabling the Manufacturer to launch their products in the EU without the need to form a separate legal entity