Blog — Insights & Updates

Regulatory AffairsNov 12, 2025 4 min

The UK Responsible Person (UKRP): Your Official Representative and First Step into the UK Market

Learn the role of the UK Responsible Person (UKRP) for medical devices and IVDs, and how they ensure compliance with MHRA requirements in Great Britain.

Regulatory AffairsNov 12, 2025 5 min

The Critical Role of the CH-REP in Swiss Market Access

Learn how the Swiss Authorised Representative (CH-REP) ensures compliance with MedDO and IvDO requirements for medical devices and IVDs in Switzerland.

Regulatory AffairsNov 7, 2025 5 min

Your Gateway to the EU Market: The Crucial Role of the Authorised Representative

Learn why an EU Authorised Representative is essential for MDR and IVDR compliance — and how QbD RepS BV helps non-EU manufacturers enter the EU market with confidence.

Regulatory AffairsOct 10, 2025 3 min

IVD Use in EU Clinical Trials: Key Considerations Under the IVDR

Unsure whether your IVD requires a legal representative under the IVDR? Learn the difference between in-house use, performance studies, and companion diagnostics.

Regulatory AffairsOct 10, 2025 5 min

Bridging the Regulatory Gap: Integrating IVDs into Global Clinical Trials

Learn how to integrate IVDs into global clinical trials while meeting IVDR and CTR requirements. Practical tips, real-world cases, and QbD expertise.

Regulatory AffairsSep 4, 2025 1 min

Annex XIV Applications: Avoid These 5 Common Delays

Annex XIV performance study applications often face delays. Discover the 5 most common causes and how to avoid them for smoother IVDR compliance.

ClinicalJun 25, 2025 1 min

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

Achieve IVDR compliance for large-panel Next-Generation Sequencing (NGS). Validate genetic variants and meet performance requirements with the right strategy.

Regulatory AffairsJun 4, 2025 4 min

Can IVDR Be Your Global Regulatory Compass for Market Entry?

Learn how IVDR aligns with FDA standards, where they diverge, and how to use your IVDR compliance as a springboard for global IVD market access.

Regulatory AffairsMay 5, 2025 3 min

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

IVD manufacturers must align ISO 13485 and IVDR for a compliant Quality Management System. This article explores key considerations for harmonizing these frameworks.

Regulatory AffairsMar 26, 2025 2 min

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

This article offers a breakdown of the three key pillars of clinical evidence: scientific validity, analytical performance, and clinical performance. Clear guidance on tailoring your approach based on device risk class and type is provided, along with best practices for evaluating the state of the art and integrating it into your performance evaluation. It clarifies postmarket performance follow-up (PMPF) requirements and how they support your benefit-risk assessment.

Regulatory AffairsFeb 18, 2025 6 min

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

Discover why usability testing is essential for compliance and safety in Near-Patient and self-testing devices under the IVDR. Learn key guidelines, study designs, and tips for successful usability evaluations.

Regulatory AffairsJan 7, 2025 3 min

Why is Clinical Performance key to a successful IVDR submission?

Did you know that the IVDR mandates robust clinical evidence to support the validity and performance of IVD assays? In this article we'll explore the role of Clinical Performance in a smooth IVDR submission.

Regulatory AffairsClinicalNov 13, 2024 4 min

What Are the Requirements for IVD Clinical Performance Studies Under IVDR and ISO 20916?

Learn the essential requirements for conducting IVD clinical performance studies under the IVDR and ISO 20916:2024.