CE Marking Services

The healthcare landscape in the European Union (EU) is changing, with substantial advances in medical technology resulting in more tailored and effective treatment alternatives.

CE Marking Services Overview

In the European Union (EU), medical device companies are required to meet stringent requirements and obtain medical device CE certification according to EU Medical Device Regulation (EU MDR) 2017/745. Freyr Solutions, a world leader in CE marking services compliance, provides expert assistance to medical device manufacturers to meet intricate requirements for CE markings promptly.

Freyr has supported manufacturers in the compilation and submission of over 100 CE Files.

Process for CE Marking Registration for Medical Device

  • Identify and classify the medical device under EU MDR/IVDR according to Annex VIII and determine if an audit by Notified Body (NB) is required based on the classification.
  • Establish a Quality Management System (QMS) for the device as per ISO 13485:2016.
  • Plan and conduct device-specific studies for necessary data generation.
  • Compile a technical file as per EU MDR 2017/745 or EU IVDR 2017/746.
  • Submit the technical file and device for an audit by NB.
  • After passing the NB Audit, prepare a Declaration of Conformity (DoC) asserting compliance with EU IVDR/MDR.
  • Once the device is CE marked, the manufacturer may have to provide all the documentation supporting CE mark to the Authorized Representative, distributors, or importers, as well as the competent authority if requested.
  • Post-market Surveillance (PMS) plan development services for both medical devices and In Vitro Diagnostic (IVD) devices.

How Prepared Are You for the CE Certification?

Placing a medical device in the EU region can be daunting because of multiple regulatory hurdles for obtaining a CE marking certification. Freyr can support you in making your journey towards medical device CE certification smoother with our regulatory experts.

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CE marking guide: 

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Medical Device Regulatory Services in Europe

Freyr offers a one-stop-shop solution for all your CE marking services requirements for placing your medical device in Europe.

Our expertise includes:

  1. Regulatory Strategy and Classification:
    • Expert identification and classification of your medical device.
    • Determine the need for NB audits based on device classification.
  2. Quality Management System (QMS):
    • Establishment and implementation of a robust QMS in accordance with ISO 13485:2016.
  3. Clinical and Performance Data:
    • Planning and execution of medical device-related studies to generate essential clinical and performance data.
    • Data analysis and documentation to support regulatory submissions.
  4. Technical File Compilation:
    • Preparation of a comprehensive technical file as per EU MDR 2017/745 or EU IVDR 2017/746.
  5. Notified Body (NB) Coordination:
    • Submission of the technical file and coordination with the NB for device audits and addressing any queries and issues throughout the audit process.
  6. Declaration of Conformity (DoC):
    • Preparation of the DoC, asserting compliance with EU MDR/EU IVDR after passing the NB audit with support in maintaining compliance post-certification.
  • Successful submissions for a varied class of devices ranging from simple Class I devices to complex devices such as Class III devices, Implants, SaMDs.
  • Local affiliate access to meet the challenges of authority and language-specific requirements.
  • Dedicated Medical Writing team for CE projects.
  • Dedicated personnel to provide Medical Device and IVD Regulatory support.
  • In-country or legal representative support with a cost-effective model.
  • Exclusive delivery center in the UK.

For end-to-end regulatory support on EU MDR, reach out to Freyr

Get expert advice on your EU MDR compliance