EU MDR & IVDR Regulatory Consulting Services

Our complete Technical Documentation File preparation services help you achieve full compliance with EU MDR and IVDR regulations for your medical devices and in vitro diagnostics.

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How We Support

Technical Documentation (MDR / IVDR)

Structured compilation and review of EU technical documentation aligned to MDR and IVDR requirements.

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Clinical Evaluation Plan and Report

Review and assessment of clinical data and state of the art to conform with Regulations and Notified Body expectations

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Post Market Activities

Planning and implementation of post-market surveillance activities, including PMS, PMCF and PMPF

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Risk Management (ISO 14971)

Risk management planning and documentation aligned to ISO 14971 and integrated with clinical and PMS outputs.

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Labelling & IFU Review

Regulatory review of labels and IFUs to ensure consistency with intended use and EU requirements.

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Regulatory Strategy

Practical regulatory strategy and planning to support efficient EU market access and compliance.

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Frequently Asked Questions

Questions we commonly receive from device manufacturers emabrking on EU MDR and IVDR compliance:

Yes. We support manufacturers with both new device submissions and the transition of legacy devices from the MDD or IVDD to MDR or IVDR, including gap analysis, remediation planning, and documentation updates.

Yes. We provide support for the compilation, review, and remediation of EU technical documentation in line with MDR and IVDR requirements, including Annex II and III content, GSPR mapping, and integration of clinical, risk, and PMS documentation.

Absolutley, this is one of our most common services. We assist manufacturers in preparing documentation for Notified Body review and in responding to non-conformities or review comments, including targeted remediation and clarification support.

Yes. We support ongoing compliance activities, including post-market surveillance planning, PSURs, PMCF / PMPF activities, labelling updates, and regulatory strategy as products evolve over their lifetime.

Ensure your compliance with the expertise of Practical RA

Talk to our team of experts to see how we can launch your business in the EU market.

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