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IVDR Compliance for Next-Generation Sequencing (NGS): Key Strategies | QbD Group

IVDR Compliance for Large-Panel Next-Generation Sequencing (NGS) Devices: A Strategic Guide

Clinical In Vitro Diagnostics EU IVDR

Jun 25, 2025 3:02:17 PM

Next-Generation Sequencing (NGS) has revolutionized precision oncology. By enabling the simultaneous...

Can IVDR Guide Global Market Access for IVDs? | QbD Group

Can IVDR Be Your Global Regulatory Compass for Market Entry?

Regulatory Affairs In Vitro Diagnostics EU IVDR

Jun 4, 2025 4:51:11 PM

The In Vitro Diagnostic Regulation (IVDR) in the EU is widely considered one of the most rigorous re...

Why do I still need to look at my QMS under the IVDR if it is ISO 13485 certified? - QbD Group

Why do I still need to look at my QMS under the IVDR if it is ISO 13485 certified?

Regulatory Affairs In Vitro Diagnostics EU IVDR

May 6, 2025 12:00:00 AM

In the In Vitro Diagnostic (IVD) medical device industry, adhering to regulatory requirements is par...

Establishing and Maintaining the Right Level of Clinical Evidence under the EU IVDR | QbD Group

Establishing and Maintaining the Right Level of Clinical Evidence under the EU IVDR

Regulatory Affairs Clinical In Vitro Diagnostics EU IVDR

Mar 26, 2025 11:20:26 AM

We’re proud to highlight a new publication by Pieter Bogaert, PhD—senior RA IVD consultant at QbD Gr...

What Makes Usability Testing Crucial for Near-Patient and Self-Testing Devices under IVDR?

What Makes Usability Testing Crucial for Near-Patient and Self-Testing Devices under IVDR?

Regulatory Affairs Clinical In Vitro Diagnostics EU IVDR

Dec 4, 2024 12:00:00 AM

IVDR & ISO 20916: Essential Requirements for IVD Clinical Performance Studies - QbD Group

What are the requirements for IVD Clinical Performance Studies Under IVDR and ISO 20916?

Regulatory Affairs Clinical In Vitro Diagnostics EU IVDR

Nov 14, 2024 12:00:00 AM

Why is Clinical Performance key to a successful IVDR submission - QbD Group

Why is Clinical Performance key to a successful IVDR submission?

Regulatory Affairs Clinical In Vitro Diagnostics EU IVDR

Oct 30, 2024 12:00:00 AM

The In Vitro Diagnostic Regulation (IVDR) represents a major shift in the regulatory landscape for I...

In-House Devices (IHDs): The Impact of IVDR, ISO 15189:2022’s Update, and MDCG 2023-1 in the EU - QbD Group

In-House Devices (IHDs): The Impact of IVDR, ISO 15189:2022’s Update, and MDCG 2023-1 in the EU

Quality Assurance In Vitro Diagnostics EU IVDR

May 24, 2024 1:00:00 AM

In May 2022, the European Union (EU) ushered in the In Vitro Diagnostic Regulation (IVDR), marking a...

Post-Market Success under IVDR: Prioritizing PMS & PMPF - QbD Group

Post-Market Success under IVDR: Prioritizing PMS & PMPF

Regulatory Affairs Clinical In Vitro Diagnostics EU IVDR PMS

May 7, 2024 12:15:00 AM

Understanding IVDR requirements To leverage the transitional provisions and ensure compliance with I...

The Crucial Role of Clinical Evidence in IVDR Compliance - QbD Group

The Crucial Role of Clinical Evidence in IVDR Compliance

Regulatory Affairs Clinical In Vitro Diagnostics EU IVDR

Apr 30, 2024 12:15:00 AM

In the In Vitro Diagnostic Medical Devices (IVD) manufacturing landscape, compliance with regulatory...

Why start building IVDR-compliant Technical Documentation now? - QbD Group

Why start building IVDR-compliant Technical Documentation now?

Regulatory Affairs Clinical In Vitro Diagnostics EU IVDR

Apr 24, 2024 12:15:00 AM

With the European Commission’s proposal for extending the transitional period for In Vitro Diagnosti...

IVDR transitional extension: Why would I still move full speed ahead? - QbD Group

IVDR Transitional Extension: Why full speed ahead is still the best strategy

Regulatory Affairs Clinical In Vitro Diagnostics EU IVDR

Apr 9, 2024 12:15:00 AM

In the dynamic landscape of medical device regulations, the recent proposal by the European Commissi...

The Impact of EU IVDR on Clinical Trials - QbD Group

The Impact of EU IVDR on Clinical Trials

Regulatory Affairs Clinical In Vitro Diagnostics EU IVDR

Mar 25, 2024 12:30:00 AM

We are pleased to share this meaningful article by two of our senior RA IVD consultants, Pieter Boga...

Blog - Anticipate the Notified Body Rush: Ensure Timely MDR/IVDR Compliance - QbD Group

Anticipate the Notified Body Rush: Ensure Timely MDR Compliance

Regulatory Affairs Medical Devices EU MDR EU IVDR

Jan 11, 2024 8:00:00 PM

The rules outlined in the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) ...

PRRC under MDR and IVDR: meaning, requirements, and responsibilities - QbD Group

PRRC under MDR and IVDR: meaning, requirements, and responsibilities

Regulatory Affairs Medical Devices EU MDR EU IVDR

Jun 10, 2022 1:00:00 AM

PRRC: meaning of this new role under MDR and IVDR The Person Responsible for Regulatory Compliance o...

From IVDD to IVDR: avoid these pitfalls to get your CE marking in time - QbD Group

From IVDD to IVDR: avoid these pitfalls to get your CE marking in time

Regulatory Affairs Medical Devices EU IVDR

Oct 12, 2021 12:15:00 AM

In vitro diagnostic (IVD) medical devices (Manufacturers | Internal Market, Industry, Entrepreneursh...

Blog - IVDR classification of in-vitro diagnostic medical devices: a brief guide for manufacturers - QbD Group

IVDR classification of in-vitro diagnostic medical devices: a brief guide for manufacturers

Regulatory Affairs Medical Devices EU IVDR

Sep 29, 2021 1:00:00 AM

In vitro diagnostic medical devices (IVDs) have long been a part of our healthcare industry. Recentl...