EU Market Access for Medicals and IVDs

View our EU Market Access services

We work with clients to solve their biggest challenges in regulatory affairs, quality assurance, and device risk mitigation.

Certificate of Free Sale (CFS) for Medical Device Exports

Emergo helps medical device companies secure Certificate of Free Sale (CFS) for medical device exports to countries around the world.

Chart Your Course to New Markets with our Regulatory Affairs Management Suite

RAMS can help you navigate complex medical device and IVD regulatory affairs activities with powerful tools to simplify your work and provide market insights.

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Choose Your Path for Market Growth.

Scalable RA/QA SaaS solution for medical device and IVD manufacturers

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Clinical Evaluation Reports (CER) for Medical Devices

Compliance support for Clinical Evaluation Reports (CERs), Revision 4 standards and EU Medical Devices Regulation (MDR 2017/745).

EU MDR Compliance Consulting for Cosmetic and Aesthetic Products

Learn which cosmetic and aesthetic products fall under EU MDR requirements and how your company should prepare for MDR compliance.

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EU Medical Device Vigilance and Incident Reporting

Learn how we can assist with European medical device vigilance and adverse event reporting, FSCA reports, post-market monitoring and creating vigilance procedures.

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European Authorized Representative for Medical Device and IVD Companies

European authorized representative (EC REP) for medical device and IVD companies. Official EU Authorized Representative for 1,000+ manufacturers worldwide.

European CE Marking Strategy for Medical Devices

Emergo has a well-established presence in the EU with offices in the UK, Germany, France, and The Netherlands. We have assisted hundreds of medical device manufacturers with CE compliance for Europe.

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European CE Technical Documentation for Medical Devices

We help medical device and IVD companies prepare Technical Files and Design Dossiers to obtain CE Marking. Learn more about our Technical File services.

European IVD CE Marking Services

ANSWERED ON THIS PAGE:

What is the regulatory process for IVDs in Europe?
What is the European classification scheme for IVDs?
How will IVD requirements change under the new In-Vitro Diagnostic Regulation (IVDR)?

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European Post-market Clinical Follow-up Studies (PMCF) for Medical Devices

Emergo assists medical device manufacturers with post-market clinical follow-up (PMCF) studies, investigations, clinical trial management, data validation and more.

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Gap Analysis: EU MDD to MDR for Medical Device CE Marking

Emergo by UL's EU MDD to MDR 2017/745 gap analysis and strategy recommendations can help you make a smooth transition and avoid unforeseen challenges.

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European Union

Certificate of Free Sale (CFS) for Medical Device Exports

Chart Your Course to New Markets with our Regulatory Affairs Management Suite

Choose Your Path for Market Growth.

Clinical Evaluation Reports (CER) for Medical Devices

EU MDR Compliance Consulting for Cosmetic and Aesthetic Products

EU Medical Device Vigilance and Incident Reporting

European Authorized Representative for Medical Device and IVD Companies

European CE Marking Strategy for Medical Devices

European CE Technical Documentation for Medical Devices

European IVD CE Marking Services

European Post-market Clinical Follow-up Studies (PMCF) for Medical Devices

Gap Analysis: EU MDD to MDR for Medical Device CE Marking

Request information from our specialists

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European Union

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Certificate of Free Sale (CFS) for Medical Device Exports

Chart Your Course to New Markets with our Regulatory Affairs Management Suite

Choose Your Path for Market Growth.

Clinical Evaluation Reports (CER) for Medical Devices

EU MDR Compliance Consulting for Cosmetic and Aesthetic Products

EU Medical Device Vigilance and Incident Reporting

European Authorized Representative for Medical Device and IVD Companies

European CE Marking Strategy for Medical Devices

European CE Technical Documentation for Medical Devices

European IVD CE Marking Services

European Post-market Clinical Follow-up Studies (PMCF) for Medical Devices

Gap Analysis: EU MDD to MDR for Medical Device CE Marking

Request information from our specialists

Thank you! We've received your request.