---
title: "Cumplimiento del IVDR y Certificación CE — Regulatory Affairs | QbD Group"
description: "El Reglamento IVDR (UE) 2017/746 ha transformado el acceso de los IVD al mercado europeo. QbD Group acompaña a los fabricantes en todo el proceso de certificación CE."
url: https://qbdgroup.com/es/servicios/regulatory-affairs/cumplimiento-ivdr-certificacion-ce
type: "Page"
language: es
publisher: "QbD Group"
citation: "QbD Group, \"Cumplimiento del IVDR y Certificación CE — Regulatory Affairs | QbD Group\", https://qbdgroup.com/es/servicios/regulatory-affairs/cumplimiento-ivdr-certificacion-ce"
---

# IVDR Compliance & CE Certification

Strategic IVDR compliance for secure and sustainable EU market access

The EU In Vitro Diagnostic Regulation (EU) 2017/746 has fundamentally changed how in vitro diagnostics access the European market. QbD Group supports manufacturers with end-to-end IVDR compliance services, from regulatory roadmap to CE certification and long-term post-market compliance.

## What does IVDR compliance require?

The EU In Vitro Diagnostic Regulation (EU) 2017/746 has fundamentally changed how in vitro diagnostics access the European market. Compared to IVDD, IVDR introduces **stricter performance evaluation requirements**, expanded technical documentation, increased Notified Body involvement, and reinforced post-market obligations.

For most IVDs, CE certification under IVDR now requires a structured regulatory strategy, a compliant Quality Management System, robust clinical and analytical evidence, and continuous lifecycle oversight.

QbD Group supports manufacturers with **end-to-end IVDR compliance services**. From regulatory roadmap to CE certification and long-term post-market compliance.

## How we support your IVDR journey

QbD Group guides you through every stage of the IVDR process, ensuring structured preparation, smooth Notified Body interaction, and sustainable compliance.

We build and maintain **IVDR-compliant quality management systems** that stand up to Notified Body scrutiny.

- Design, implementation, or upgrade of **IVDR-compliant QMS** (Article 10)

- Translation of IVDR requirements into practical **processes, procedures, and templates**

- **QMS gap assessments** with hands-on remediation support

- Development of **company-specific quality documentation** (not generic templates)

- Execution of **internal audits, supplier audits, and mock Notified Body audits**

- Ongoing **QMS maintenance and inspection readiness** support

## Key IVDR requirements

IVDR compliance requires manufacturers to demonstrate conformity with Regulation (EU) 2017/746 before placing an IVD on the EU market:

### Risk-Based Classification (Class A–D)

Risk class is determined by the intended purpose and defines the applicable conformity assessment route.

### Notified Body Certification

Under IVDR, most IVDs require conformity assessment and certification by a designated Notified Body.

### IVDR Technical Documentation (Annex II & III)

Your technical documentation must demonstrate that the device meets IVDR safety and performance requirements.

### Performance Evaluation & Clinical Evidence

IVDR requires demonstration of scientific validity, analytical performance, and clinical performance.

### Post-Market Surveillance (PMS & PMPF)

Continuous monitoring of safety and performance throughout the device lifecycle.

### IVDR-Compliant Quality Management System

A structured QMS governing the full device lifecycle in accordance with IVDR.

### Person Responsible for Regulatory Compliance (PRRC)

IVDR requires designation of a qualified person responsible for regulatory compliance.

Por qué QbD Group

## Tu socio de confianza

With proven expertise in IVD and extensive hands-on experience, QbD Group combines flexibility with capacity to support your IVDR journey.

**+150 IVDR technical files** written

**+250 clinical performance studies** executed

**Experts** with years of **hands-on IVD industry experience**

**Proven track record**

**ISO 13485 and ISO 27001** certified

Recognized by **Notified Bodies**

**Flexible partnerships**, from custom support to full outsourcing

## Let's talk Regulatory Affairs

From regulatory strategy to product approval, our experts are ready to guide you through every step.

Contacta con un experto

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Source: https://qbdgroup.com/es/servicios/regulatory-affairs/cumplimiento-ivdr-certificacion-ce — © QbD Group. Quote freely with attribution and a link back.