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CE Certification Consultancy for Medical Devices and IVDs

  2. Services
  3. CE Marking Consultancy

Maven Profcon Services LLP is a trusted CE certification consultancy service provider for complete regulatory support for medical devices and In Vitro Diagnostic Devices (IVDs) under EU MDR 2017/745 and EU IVDR 2017/746 regulations. As experienced professionals in CE marking, we help manufacturers identify the requirements for CE marking for their products, prepare the technical documentation required by EU MDR and IVDR, assist in the selection of a notified body, and provide audit support. Our CE certification consultancy services focus on practical compliance, clear documentation, and smooth coordination with Notified Bodies.

Services We Provide for CE Marking Consultancy

CE certification consultants role to obtain CE marking under EU MDR 2017/745

Our team will identify the requirements under EU MDR for your product. We will draft the documents required by EU MDR, such as the list of applicable standards, GSPR, risk management and clinical evaluation documentation, declaration of conformity, and more. Our team will help you finalize the performance testing requirements for your product and support you during notified body audits as well.

CE certification consultancy for software as Medical Device

Our CE certification consulting services help SaMD manufacturers through the European Medical Device Regulation (EU MDR) to ensure compliance. Our team assists with all steps, including conformity assessment, making sure your software meets all necessary standards for market approval in Europe. We help you understand the European medical device regulation EU MDR 2017/745 and ensure your SaMD is compliant, safe, and ready for certification.

Post Market Surveillance (PMS) for Medical Devices

Our CE certification consultant prepares PMS documentation in accordance with the requirements of the EU MDR and IVDR. PMS documentation for medical devices includes the PMS plan and report, PSUR, and PMCF plan and report. For IVDs, the PMPF plan and report replace the PMCF plan and report; however, all other PMS documents are also required as part of the IVD PMS documentation.

CE certification consultancy

CE certification consultants role to obtain CE marking In Vitro Diagnostic Devices (IVDs)

We provide end-to-end support to IVD manufacturers in preparing documents such as analytical and clinical performance protocols and reports, performance evaluation plans and reports, usability documentation, GSPR, risk management files, and more. Our team also supports conformity assessment audits with notified bodies and helps resolve non-conformities raised by notified bodies on technical documentation.

Clinical evaluation for Medical Devices

We provide support in clinical evaluation report writing for medical devices. The CER preparation includes the clinical evaluation plan, literature search protocol & report, and clinical evaluation report. Our team prepares the clinical evaluation that complies with EU MDR requirements.

European Authorized Representative (EAR)

We offer European Authorized Representative (EAR) services, compliant with EU MDR 2017/745 and EU IVDR 2017/746. Manufacturers based outside of Europe are required to appoint an EAR to obtain or maintain CE marking for their products.

Why Choose Maven Profcon Services as Your CE Certification Consultants

  • Experienced EU MDR & IVDR regulatory team
  • Practical, step-by-step compliance approach
  • One stop solution for any regulatory requirement for medical devices, IVDs, and SaMD
  • Single point contact during the entire project of CE certification
  • Manufacturer get status report of their project every week
  • Clear documentation aligned with Notified Body expectations
  • End-to-end CE certification consultancy service

Frequently Asked Questions

Yes, all medical devices and IVDs intended for sale in the European Economic Area (EEA) must have a CE mark. The CE marking shows that the device meets the safety, health, and performance requirements as per EU MDR & IVDR

CE certification is issued after a successful conformity assessment performed by a Notified Body, which is an independent organization designated by an EU Member State. These Notified Bodies are authorized to evaluate whether a medical device or In Vitro Diagnostic Device (IVD) meets the essential safety and performance requirements under EU MDR 2017/745 or EU IVDR 2017/746.
You can find the approved notified bodies for EU MDR 2017/745 from below link;
EU MDR Notified Bodies
You can find the approved notified bodies for IVDR 2017/746 from below link;
EU IVDR Notified Bodies

Non-sterile, non-measuring Class I medical devices and Class A IVD devices do not require Notified Body CE certification.

The cost of CE certification for medical devices and In Vitro Diagnostic Devices (IVDs) varies significantly depending on several factors, including:
The risk classification of the device (Class I, IIa, IIb, III, or A–D for IVDs)
The complexity and type of the device
The scope of the conformity assessment and involvement of a Notified Body
Whether clinical evaluations, performance studies, or third-party testing are required.

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