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.

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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).

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Due Diligence Services for Mergers and Acquisitions

Our due diligence services help medical device companies navigate complex regulatory requirements to avoid post-transaction complications.

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EU IVDR Compliance Training for In Vitro Diagnostic Manufacturers

We can prepare your team with on-site or remote In Vitro Diagnostic Medical Devices Regulation (EU IVDR) training provided by our experienced regulatory consultants.

EU MDR Classification of Medical Devices

Learn the EU MDR classification of medical devices and deepen your understanding of the European CE marking regulatory process with our regulatory consulting.

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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European Union

Certificate of Free Sale (CFS) for Medical Device Exports

Clinical Evaluation Reports (CER) for Medical Devices

Due Diligence Services for Mergers and Acquisitions

EU IVDR Compliance Training for In Vitro Diagnostic Manufacturers

EU MDR Classification of 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

Request information from our specialists

Thank you! We've received your request.

European Union

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Certificate of Free Sale (CFS) for Medical Device Exports

Clinical Evaluation Reports (CER) for Medical Devices

Due Diligence Services for Mergers and Acquisitions

EU IVDR Compliance Training for In Vitro Diagnostic Manufacturers

EU MDR Classification of 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

Request information from our specialists

Thank you! We've received your request.