Navigate the European Market with Confidence

Looking for a EU MDR Consultants

Identifying the correct Device Classification

Completing the appropriate Conformity Assessment

Preparing comprehensive Technical Documentation

Appointing a European Authorized Representative (for non-EU manufacturers)

Undergoing Notified Body review (for most risk classes)

Implementing a Post-Market Surveillance (PMS) system

Ensuring compliance with UDI and Labelling requirements

Demonstrating sufficient Clinical Evidence and Risk Management

Achieving CE Marking involves:

CE marking under MDR is not just a milestone — it’s a lifecycle commitment.

We help you build a system that ensures ongoing compliance, safety, and market access. Whether you’re a startup, OEM, or transitioning from MDD to MDR, we help you build the foundation for a successful CE certification.

Our EU MDR Solutions

We offer structured, hands-on support across every stage of the CE certification journey.

Mapping Classification & Regulatory Strategy

We start with defining the right regulatory pathway for your device.

• Determining the correct risk classification under EU MDR.

• Identify applicable conformity assessment procedures.

• Map the relevant Annexes, Common Specifications, and harmonized standards.

• Recommend an efficient certification roadmap tailored to your device and market strategy.

Whether you're unsure about risk class or which route to take, we bring clarity and direction

Technical Documentation Support

We help you prepare a complete, audit-ready technical file that meets EU MDR requirements.

• Assemble or review documentation per Annex II and III.

• Prepare core sections: device description, design verification, risk management, GSPR checklist, and labelling.

• Ensure alignment with standards like IEC 60601, ISO 10993, and ISO 14971.

• Format and organize files for Notified Body review readiness.

Whether you’re starting from scratch or updating legacy documents, we ensure MDR compliance.

We help integrate MDR-specific requirements into your existing QMS—or build one from the ground up.

• Align your QMS with ISO 13485:2016 and EU MDR Chapter II requirements.

• Draft or update SOPs for MDR-required processes (e.g., vigilance, UDI, PMS, PMCF).

• Establish controls for design, production, CAPA, change management, and traceability.

• Prepare for Notified Body QMS audits.

For manufacturers without an EU-ready QMS, we make compliance achievable and sustainable.

Implement MDR-compliant QMS

We guide you through the demanding clinical evidence requirements under MDR.

• Develop a Clinical Evaluation Plan and Clinical Evaluation Report (CER).

• Conduct or support literature review, appraisal, and data analysis.

• Provide guidance on equivalence justification, where applicable.

• Ensure your clinical evaluation meets current EU regulatory expectations for methodology, data integrity, and reporting clarity.

Our clinical evaluation services are tailored to your device risk class and data availability.

Clinical Evaluation Support

Post-market & Vigilance Compliance

We help you stay compliant even after your device is CE marked.

• Develop Post-Market Surveillance (PMS) and Post-Market Clinical Follow-Up (PMCF) plans.

• Prepare Periodic Safety Update Reports (PSUR).

• Create procedures for adverse event reporting, trend analysis, and field safety corrective actions (FSCA).

• Ensure readiness for market surveillance by EU authorities

• Support in periodic updates to SSCP based on PMS and clinical follow-up data

We help you build a post-market system that not only satisfies MDR, but also improves product safety and reliability.

Notified Body Audit Preparation & Query Handling

We ensure you’re confident and well-prepared for your CE audit.

• Conduct mock audits to assess documentation and system gaps.

• Assist in responding to Notified Body observations or non-conformities.

• Help with CAPA documentation and follow-up actions.

• Support during technical file reviews or QMS inspections.

With our guidance, you’re not alone during critical regulatory evaluations.

Key Deliverables

• Complete Technical Documentation

• Clinical Evaluation Report (CER)

• Risk Management File (RMF)

• PMS & PMCF Plan (if applicable)

• Periodic Safety Update Report (PSUR)

• Summary of Safety & Clinical Performance (SSCP) (if applicable)

• General Safety and Performance Requirements (GSPR) Checklist

• Declaration of Conformity (DoC)

End-to-end Compliance Support

Audit-Ready Technical Documentation

Notified Body Approval Support

Post-market Surveillance setup

Ongoing Regulatory Support

Who We Help?

First-Time Applicants

Manufacturers Without In-House Regulatory Teams

Whether you're a Startup, SME, or an established manufacturer, we tailor our support to meet your specific product, process, and team needs.

Companies Transitioning from MDD to MDR

OEMs & Contract Manufacturers

Startups & Innovation-Driven Enterprises

Established Manufacturers Seeking Market Expansion

Ready to start your MDR Journey?

Let’s talk about your device, timelines, and goals. Whether you're just beginning or need support for a specific module—risk, CER, PMS—we’re here to help

Our Workflow

Why Choose VIDHA?

Expertise You Can Trust

Hands-on experience, backed by a strong understanding of global and Indian regulatory frameworks.

Personalized Solutions

We tailor every document, process, and support plan to your specific device class, regulatory pathway, and business goals.

Reliable & Confidential Support

We prioritize confidentiality, integrity, and compliance — ensuring your data and submissions are handled with care and professionalism.

Our services are focused, efficient, and aligned with your timelines and budgets.

Timely & Cost-Effective Delivery

Frequently asked questions

FAQs