Emergo by UL provides in-country representation in the UK and EU
Emergo is uniquely positioned to help you navigate regulatory compliance in Europe as well as the UK post-Brexit. You can establish representation in the UK and the EU through our offices in Sheffield, UK and The Hague, Netherlands. Here’s how we can help:
- For UK-based companies, we can act as your EC REP.
- For EU-based companies, we can act as your UKRP, if needed.
- Perform a completeness review of key components of your Technical File and review your draft labeling.
Emergo is one of the largest European Authorized Representatives for medical device and IVD manufacturers, representing hundreds of companies worldwide. Contact us to learn more about UK and EU representation services.
Additional services for Europe:
- CE Mark Certification for Medical Devices
- Clinical Evaluation Reports (CER) for Medical Devices in Europe
- EU IVDR Gap Assessment and CE Transition for IVD Companies
- EU MDR compliance consulting for cosmetic and aesthetic products
- EU Medical Device Vigilance Reporting in Europe
- EU Post-Market Clinical Follow-up Studies (PMCF) for Medical Devices
- European Authorized Representative for Clinical Trials
- European Authorized Representative for Medical Device Companies
- European MDR 2017/745 Gap Assessment and CE Transition Strategy
- European Union Medical Device Classification
- In Vitro Diagnostics Regulation (EU IVDR) On-Site Training
- IVD Certification and Registration to Obtain CE Marking in Europe
- Medical Device and IVD Emergency Use Routes in Europe
- Medical Device Technical File and Design Dossier for EU CE Marking
- Switzerland Representative for Medical Device Companies