The clock is ticking for medical device manufacturers operating in the European Union as we move tow...

If you are a manufacturer of medical devices or in vitro diagnostic (IVD) devices based outside Swit...

For medical device and in vitro diagnostic (IVD) manufacturers located outside the United Kingdom, a...

For medical and in vitro diagnostic device manufacturers based outside the European Union, accessing...

Under the EU Medical Device Regulation (MDR), usability is no longer a ‘nice-to-have’—it’s a core co...

In-silico testing — using computational modeling and simulation techniques — has rapidly become an i...

As global clinical trials grow in scale and complexity, integrating In Vitro Diagnostics (IVDs) into...

The use of in vitro diagnostic (IVD) devices in clinical trials has become increasingly complex unde...

Balancing human health, regulatory compliance, and environmental protection is becoming increasingly...

In vitro diagnostic devices (IVDs) play a critical role in modern healthcare. From disease diagnosis...

Post-Market Clinical Follow-up (PMCF) is no longer optional. Under the EU Medical Device Regulation ...

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

Over the past few decades, the pharmaceutical industry has seen a dramatic shift in how regulatory s...

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

An Investigational Medicinal Product Dossier (IMPD) is a critical document required for clinical tri...

The COVID-19 pandemic wasn’t just a global health crisis — it was a wake-up call for how vulnerable ...

In recent years, medicinal products for the EU market have been increasingly manufactured outside th...

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

Over the years the pharmaceutical industry has become one of the most highly regulated, second only ...

1. Start with a clear intended purpose A strong clinical performance strategy begins with a well-def...

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

The Scientific Symposium on Advanced Therapy Medicinal Products (ATMPs), organized by the Committee ...

For Medicinal Products, the Product Information (PI) is a key document that provides a summary of of...

In 2023, assessment timelines for Clinical Trial Authorization (CTA) applications and substantial am...

What is drug readability and why is it important? Readability refers to the clarity and ease with wh...

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

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

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

In recent discussions, the European Commission’s proposal for extending the transitional period for ...

With the 2017 Medical Devices Regulation (MDR) fully operational from May 26, 2021, Article 117 has ...

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

The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has been conducting Good Pharmacov...

With the Medical Device Regulation (MDR 2017/745) being more stringent than the previous European Me...

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

During a webinar held on March 12, 2024, they unveiled the features of Release 1 of this innovative ...

In earlier blog posts, we spotlighted the EU member states – Germany, Belgium, and France – and thei...

U.S. Basic Requirements for DTx Products Subject to the U.S. Health Authority (FDA) regulations, spe...

Digital therapeutics (DTx) represent an exciting frontier in healthcare, leveraging clinically valid...

Medical Devices CE certified under the European Medical Device Directive (MDD) or the Active Implant...

Germany has always been renowned for its meticulous attention to detail, often described by the term...

All Digital Therapeutics (DTx) must adhere to the EU’s foundational CE marking requirements as detai...

In a landscape marked by escalating healthcare expenses and budgetary restrictions, mobile health (m...

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

One of the initial changes implemented by the UK’s Medicines and Healthcare products Regulatory Agen...

Plasmids are used in various research and biotechnology applications, such as gene therapy, vaccine ...

Immunotherapy has become an important therapeutic alternative to surgery, chemotherapy, and radiatio...

The last two years have seen significant changes in the approval management of clinical trials. In t...

On 22 May 2023, Irdeto and QBD Group sat down to discuss the developments of the medical device regu...

On 26 April 2023, the European Commission adopted a proposal for a new Directive and a new Regulatio...

In order to give patients quicker access to cutting-edge treatments and therapies, the UK government...

The Medicines and Healthcare Products Regulatory Agency ( MHRA) Good Manufacturing and Distribution ...

Annex XVI of the MDR EU 2017/745 lists products (6 categories) without an intended medical purpose t...

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) recently implemented a new organ...

Are you performing clinical research with medical devices? In this blog post, we provide a brief ove...

We recently published a blog post about Unique Device Identifiers (UDI). While this blog post briefl...

The European Parliament has adopted the proposal to extend the transitional period for legacy device...

ISO, IEC, EN ISO… References to standards can be confusing. What is the difference between these sta...

Custom-made medical devices are the odd ones out when it comes to the Medical Devices Regulation (EU...

In Belgium, medicine advertising is subject to specific legislation. The objective is to ensure the ...

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

Compressed gas standards The latest draft of Annex 1, Manufacture of Sterile Medicinal Products, int...

Clinical evaluation of a medical device – defined as an ongoing collection, generation, appraisal, a...

Clinical evaluation of a medical device is central to obtaining and maintain ing market approval in ...

Before marketing a medicinal product, pharmaceutical companies must obtain a marketing authorization...

CAR-T cell therapy, a groundbreaking advancement in the pharmaceutical industry over the last 20 yea...

The new medical device regulations and the associated implementation of EUDAMED should give the gene...

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

In recent years, more and more medicinal products (MP) are used in conjunction with a medical device...

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

Are you aware that the introduction of MDR may have affected your CE-marked medical software (MDSW)?...

Artificial Intelligence is the IT word in Medical Devices nowadays when it comes to software develop...

Nowadays, digital healthcare is taking an increasingly important place in the medical world through ...

What is a medical device? This crucial question often arises when bringing medical devices to market...

The EU Medical Device Regulation 2017/745 (MDR) and EU In Vitro Diagnostic Regulation 2017/746, (IVD...

Regulatory Affairs plays a crucial role in the pharmaceutical industry, especially during drug devel...

Every day, patients around the world participate in clinical trials. Their contributions are crucial...