← Market entry

Launch in the EU

Enter the EU with MDR / IVDR or centralised pharmaceutical routes, technical documentation and an EU Authorised Representative.

Notified Bodies / EMA / National Authorities6-12 months typicalEU Authorised Representative
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Requirements

What launching in European Union takes.

01Classification under MDR / IVDR or EU pharma route
02Technical documentation or CTD dossier
03Clinical or performance evidence review
04EU Authorised Representative appointment
05Notified Body engagement and conformity assessment
06EUDAMED registration and multilingual labelling
Related services

Standalone services for European Union.

Product Classification
Medical Device Classification: EU

Rule-by-rule classification under MDR 2017/745 with a written rationale memo.

CMC Regulatory Support
CMC Dossier Gap Assessment

Module 3 review with a prioritised gap and remediation list.

Other markets

Launching somewhere else?

Launch in the UKLaunch in the USALaunch in the GCCLaunch in Saudi ArabiaLaunch in IndiaLaunch in SingaporeLaunch across ASEAN

Ready to launch in European Union?

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