European Business Consultants
IVDR
Background
IVDR or In Vitro Devices Registration, Compliances required for distribution of products in EU
The EU In Vitro Diagnostic Medical Devices Regulation (IVDR 2017/746) brought significant changes to the classification, conformity assessment, and oversight of IVDs. Our consultancy was founded in the EU to directly support manufacturers navigating these challenges, especially during the ongoing IVDR transition periods.
Under IVDR, 90%+ of IVDs now require Notified Body certification—up from ~15% under the old IVDD. This massive shift created a surge in demand for regulatory expertise, technical documentation support, and conformity strategy development—areas where our EU-based consultancy specializes.
Non-EU IVD manufacturers must appoint an EU Authorized Representative (EC-REP) and align their products with the complex IVDR requirements to obtain CE marking. Our consultancy acts as a trusted partner and local point of contact, ensuring a compliant and efficient market entry.
IVDR introduced a new risk-based classification system (Class A-D), placing many formerly low-risk devices into higher scrutiny categories. Our consultants provide deep technical expertise in clinical performance studies, risk management, and PMS (Post-Market Surveillance), helping clients meet stricter standards.
Case Study
The Problem
Manufacturer in Asia has a Class B In Vitro Device
Getting CE Marking is a cumbersome and expensive process for launching the product in EU
Penetrating markets outside EU would need local compliances in each country hence significantly increasing the launch costs
Our Solutions
Cosmo Enterprises and their partners have decades of experience and hence are able to guide the Manufacturer to achieve CE certification in 9-12 months. Moreover after registration they would apply for a Free Sales Agreement hence opening up Africa and West Asia Markets without the need to perform separate compliances in each country