Manufacturers of medical or in vitro diagnostic devices without a physical presence in the EU are required to appoint an Authorized Representative. This requirement does not apply to manufacturers based in EU member states.

Labeling Requirements for the European Authorized Representative (EC-REP)

Under the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), the inclusion of the EC-REP on the device label is mandatory for manufacturers without a physical presence in the EU. This ensures a clear and accessible point of contact within the Union for regulatory authorities, healthcare professionals, and end users.

The device label must include:

• Name and Address of the European Authorized Representative

• EU-REP Symbol, placed next to the name and address to clearly indicate their role

• Language Compliance, ensuring the information is presented in a language easily understood by users and authorities in the countries where the device is placed on the market

Choosing the right Notified Body (NB) under the Medical Device Regulation (MDR) or In Vitro Diagnostic Regulation (IVDR) is one of the most strategic decisions you’ll make as a medical device or IVD manufacturer.Here’s a clear and structured approach:

1. Check the official NANDO database from the European Commission.
2. Assess Their Scope of Designation ((I, IIa, IIb, III under MDR or A, B, C, D under IVDR).
3. Consider Their Capacity and Availability: Due to high demand and limited NB resources under MDR/IVDR, many are: 
4. Not accepting new clients
5. Or have waitlists of 6–18 months

4. Evaluate Industry Experience, Reputation and Costs.

Yes. Under the IVDR, all in vitro diagnostic devices previously CE marked under the IVDD must transition to comply with the new IVDR requirements within the set transitional timelines. This includes updated classification, performance evaluation, and Notified Body involvement for most devices.

A CRO supports manufacturers by managing clinical investigations or performance studies in compliance with EU regulatory requirements. This includes study design, site selection, ethics submissions, data management, and reporting, ensuring that all activities meet the standards of MDR or IVDR, as applicable.

The timeline and cost depend on the type and complexity of the study. If you send us the protocol synopsis, we can provide an initial budget estimate to give you a general idea. The more detailed the information you share, the more accurate and comprehensive our proposal will be.