IVDR Consulting Services

We assist you with your technical documentation

The MDR is a law that regulates the manufacture, sale and use of medical devices across the European Union (EU). It was passed in 2017 and became applicable in 2021. It aims to protect the health and safety of patients by ensuring that medical devices are safe and effective.

Our IVDR consulting services ensure that your in vitro diagnostic devices comply with the strictest European standards of IVDR 2017/746

The technical documentation for IVDR is an essential part as it contains the compilation of supporting information about your in vitro diagnostic medical device (IVD).

It must be maintained throughout the product lifecycle. When introducing in vitro diagnostic medical devices to the European market, manufacturers must ensure compliance with all applicable regulations outlined in Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR).

Depending on the device classification and chosen conformity assessment approach, a notified body may need to assess one or more parts of the technical documentation.

The guidelines for the submission of technical documentation align with the criteria of the Regulation on in vitro diagnostic medical devices (IVDR), as detailed in Regulation (EU) 2017/746 in Annexes II and III.

CMC will guide you through the CE marking roadmap for in vitro diagnostic devices according to the new IVDR 2017/746 regulation to ensure compliance and place the CE Mark on your device.

Select CMC for IVDR Consulting and Ensure Compliance with European Standards

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Frequently asked questions about IVDR compliance

How can an IVDR consultant help my company?

A consultant will guide you through the compliance process, reducing the chance of costly mistakes and speeding up the process so you can stay in business.

What happens if my company does not comply with the IVDR?

If you do not comply, you will not be able to sell your products in the EU, which could mean a significant loss of revenue. In addition, you could face regulatory sanctions.

How do I know if my device is classified as in vitro diagnostic?

Consultants can help you determine if your product is an in vitro diagnostic medical device and, if so, how it is classified in terms of risk.

What are the costs associated with IVDR implementation?

Costs can vary depending on the need for clinical trials, technical documentation, risk management and more. A consultant can help you estimate these costs more accurately.

Why choose CMC Medical Devices ensure full compliance with European regulations MDR 2017/745 for medical devices?

Fast response

We promptly and efficiently address any inquiries from authorities or regulatory bodies in the countries where we operate.

Efficient communication

Our team provides fast and clear responses to any questions or concerns, minimizing delays and ensuring a smooth approval process.

Immediate support

We handle inquiries and requests from both manufacturers and regulatory bodies with speed and precision.

Quick resolution

Any compliance questions or documentation needs are addressed promptly, ensuring your product moves through the regulatory process as quickly and smoothly as possible.

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