Blogs

Placing CE-marked (IVD) Medical Devices on the UK market

The medical device industry plays a crucial role in the healthcare ecosystem, with innovations constantly emerging to improve patient care and outcomes. In the United Kingdom (UK), the introduction of the CE mark, which signifies compliance with European Union (EU) regulations, has a significant impact on the regulation and marketing of medical devices. This blog […]
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Clinical Evidence in IVDR: A Comprehensive Insight

The European Union’s Regulation 2017/247, commonly known as the In Vitro Diagnostic Regulation (IVDR), aims to enhance patient safety and to ensure the efficacy of in vitro diagnostic medical devices. Compared to its predecessor, the In Vitro Diagnostic Directive (IVDD), IVDR puts forward increased requirements and obligations for manufacturers, importers, and distributors alike. Central to […]
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The IVD Medical Device Life Cycle in the European Union

The European Union (EU) is home to a diverse and advanced healthcare ecosystem. In Vitro Diagnostic (IVD) medical devices, essential for diagnosis and monitoring, are an integral part of this system. However, before any IVD medical device reaches the hands of healthcare professionals in the EU, it undergoes a strict, well-defined life cycle. Let’s explore […]
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Changing the Intended Purpose of an IVD Medical Device in the EU

The medical device industry in the European Union is a dynamic field, governed by stringent regulations to ensure safety, quality, and efficacy. In Vitro Diagnostic (IVD) devices are a subset of medical devices that are designed to perform tests on samples taken from the human body. Earlier QRcompliance published a blog about understanding the concept […]
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EU Declaration of Conformity under IVDR

With the introduction of the In Vitro Diagnostic Medical Devices Regulation (IVDR) in the European Union (EU), the landscape for in vitro diagnostic (IVD) devices has been reshaped, bringing many new challenges for manufacturers. One crucial aspect of the IVDR is the EU Declaration of Conformity (DoC). This blog aims to explain the DoC, its […]
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Understanding Common Specifications for In Vitro Diagnostic Medical Devices in the EU

What are Common Specifications? Common Specifications are essentially a set of technical and/or clinical requirements designed to ensure that a particular IVD medical device, process, or system meets the legal obligations necessary for patient safety and effectiveness. They act as a benchmark or guideline for manufacturers, providing clear directions on the minimum requirements their products […]
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Outsourcing the PRRC Role: A Strategic Move

In today’s competitive and strictly regulated medical device industry, the role of the Person Responsible for Regulatory Compliance (PRRC) is both a necessity and a challenge. Borne from the EU’s Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), the PRRC ensures that medical products adhere to stringent standards before reaching consumers. However, as […]
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Medical Device Coordination Group (MDCG): Steering the Direction of Medical Device Regulation

As the medical technology landscape rapidly evolves, ensuring the safety, efficiency, and quality of (in vitro diagnostic) medical devices becomes more and more complex. Understanding the roles and responsibilities of key regulatory bodies, such as the Medical Device Coordination Group (MDCG), is crucial for both manufacturers and stakeholders in the industry. What is the Medical […]
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