Expert Knowledge- EU MDR Implementation

Medical device regulatory requirements are always evolving, and ECI can support your organization in keeping up to date with this changing landscape. The Medical Device Regulation (MDR) 2017/745 has been in effect in the European Union (EU) since May 26, 2021. It replaced the Medical Device Directive (MDD) and aimed to enhance the safety and performance of medical devices while ensuring a higher level of protection for patients and users.

Impact of European Union Medical Device Regulation

The European Commission defined the following improvements of EU MDR over the previous MDD:

Our Approach to Regulation Support

As with any regulatory change, the first step is to determine the gap between your current quality system and the new requirements. Our team of experts can support your organization by reviewing your quality management system documentation and historical product files to determine the most expeditious pathway to remaining in the European market. Whether additional testing is required to demonstrate state of the art compliance or rationale to bridge a perceived gap, we can review your files with the new requirements in mind and prepare and execute a clear strategy for MDR compliance.


The Benefits of ECI Solutions

In-Depth Regulatory Knowledge

Our team specializes in understanding and interpreting complex regulations. They stay abreast of updates, ensuring that your organization receives accurate and up-to-date information about EU MDR requirements.

Customized Compliance Strategies

We can assess your specific products, processes, and organizational structure to develop customized compliance strategies unique to your organization.

Risk Management Guidance

EU MDR places a strong emphasis on risk management. ECI can guide your organization in implementing effective risk management processes, helping to identify, assess, and mitigate risks associated with your medical devices.

Efficient Submission Processes

Our regulatory experts can streamline the preparation and submission of documentation required for compliance.

Interpretation of Standards & Requirements

ECI can help interpret the specific standards and requirements necessary to meet the criteria for safety and performance.

Quality Management Systems (QMS) Implementation

Our quality experts can assist in the remediation, development, and implementation of an effective and EU MDR compliant QMS.

Training & Education

ECI can provide training sessions for your internal teams, ensuring that employees are aware of the latest regulatory requirements and understand their roles in maintaining compliance.

Impact That’s Tangible

Why not see for yourself the value ECI provides to clients through technology transfer? Find insight on how we support customers through case studies specific to technology transfer.


Post Market Surveillance & Vigilance Case Study


Post Market Surveillance & Vigilance Case Study


Post Market Surveillance & Vigilance Case Study


Technology Transfer Case Study


Technology Transfer Case Study


Technology Transfer Case Study


Our Strategic Services

Our team is here to expertly guide you through every product lifecycle challenge you may encounter. Learn more about our other service offerings through the link below.

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Get Started Today

Engaging ECI provides peace of mind, knowing that your organization is proactively addressing regulatory requirements. Contact ECI today to discuss your specific requirements and learn how our solutions can simplify the path to MDR compliance for your organization.

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