Noticias y novedades
IVDR compliance deadline: how to prepare your Quality Management System (QMS) by May 26, 2025
With the entry into force of the Regulation (EU) 2017/746 (IVDR), manufacturers of in vitro diagnostic (IVD) medical devices face a series of new regulatory obligations. Among these, a key requirement is the implementation of a Quality Management System (QMS) [...]
UDI-DI mandatory from May 26, 2025: A guide for manufacturers
As of May 26, 2025, the UDI-DI (Unique Device Identifier – Device Identifier) will become mandatory for: Medical devices under MDR Class I In vitro diagnostic devices under IVDR Class B and C The obligation applies to all manufacturers, regardless [...]
Clinical Evaluation Report (CER) for MDR: Structure, Strategy, and Compliance
Understanding the Clinical Evaluation Report (CER) When it comes to medical devices, proving clinical safety and performance is not just good practice, it’s a regulatory requirement. The Clinical Evaluation Report (CER) is the document that systematically collects and evaluates all [...]
CDSCO speeds up the process: automated certificates for medical devices
India has introduced a new step toward regulatory efficiency in the MedTech sector. Yet something has shifted for medical device manufacturers in India: the Central Drugs Standard Control Organization (CDSCO) has launched an automated certification process. There was no official [...]
The UK reclaims a leading role in clinical research: What this means for medical device and IVD manufacturers
In recent years, the clinical research landscape in the United Kingdom has undergone a remarkable transformation. According to a recent analysis by the MHRA (Medicines and Healthcare products Regulatory Agency), clinical trial applications increased by 20% between 2018 and [...]
Post-Market Surveillance: A Swiss perspective on critical compliance gaps
We’ve previously highlighted how important post-market surveillance (PMS) is, not just as a regulatory requirement, but as an essential tool for safeguarding patient safety and monitoring device performance throughout its entire lifecycle. Today, we’re revisiting the topic with a focus [...]
IVD Classification: What’s new in the latest MDCG 2020-16 Rev.4 guidance?
In March 2025, the Medical Device Coordination Group (MDCG) released an update to its guidance MDCG 2020-16 Rev.4, focused on the classification of in vitro diagnostic medical devices (IVDs) under Regulation (EU) 2017/746 (IVDR). This document plays a crucial [...]
MHRA publishes its first monthly safety bulletin for medical devices and medicines
In March 2025, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) launched the first issue of its new monthly safety bulletin, a step forward in making critical safety information more transparent and easier to access. This initiative is [...]
Hemodialysis bloodlines shortage: FDA alert and clinical implications
The U.S. Food and Drug Administration (FDA) has recently issued a communication to healthcare providers regarding an ongoing shortage of hemodialysis bloodlines, a critical component in both acute and chronic dialysis treatments. These devices, responsible for connecting a patient’s [...]
