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EMA Measures Towards Efficient Approval Process for New Medicines in European Union (EU)
Improving the efficiency of the approval process for new medicines within the European Medicines Agency (EMA) involves several strategies...
Oct 13, 20243 min read
Microbiome Based Therapies : Regulations and Market Outlook
Microbiome-based therapies are a promising area in precision medicine, aiming to tailor treatments based on individual microbial...
Aug 7, 20246 min read
Biopharmaceutical Alliance Launched by India, South Korea, US, Japan, and EU
The global biopharmaceutical sector has taken a significant step towards ensuring a resilient drug supply chain with the formation of the...
Jun 7, 20243 min read
Understanding the Role of PRRC under EU MDR and IVDR
The advent of the EU Medical Device Regulations (EU MDR) and In-Vitro Diagnostic Regulation (IVDR) signals a new era of intensified...
Oct 9, 20234 min read
Key Players in Medical Device Regulation: Economic Operators under EU MDR and IVDR
In the rapidly evolving landscape of medical device regulations, understanding the roles and responsibilities of economic operators is...
Oct 2, 20235 min read
Navigating Regulatory Gray Areas: Borderline Devices in the EU MDR and IVDR Era
In the world of medical devices, categorization and classification are essential processes that determine how products are regulated and...
Oct 1, 20233 min read
Class I Medical Devices and CE Marking: Compliance Essentials
The European Union (EU) boasts one of the most stringent regulatory frameworks for medical devices in the world. For manufacturers...
Sep 30, 20233 min read
Navigating the Complex World of Combination Products: Understanding EU MDR Article 117
In the world of healthcare, many patients benefit from the use of combination products – medical devices that incorporate pharmaceuticals...
Sep 29, 20235 min read
Certifying Medical Devices in the EU: The Crucial Role of Notified Bodies under MDR and IVDR
In the ever-evolving world of medical devices, Notified Bodies play a pivotal role in ensuring the safety and efficacy of products...
Sep 28, 20234 min read
The CE Mark is Just the Beginning: Post-CE Compliance under EU MDR
The introduction of the European Union Medical Device Regulation (EU MDR) 2017/745 marked a significant milestone in the world of medical...
Sep 27, 20234 min read
EU MDR Compliance: Navigating the Essential EUDAMED Modules
The European Medical Devices Regulation (EU MDR) has ushered in a new era of regulations for medical devices in the European Union. Among...
Sep 25, 20234 min read
Deciphering Medical Device Risk Classification Under EU MDR
The European Union Medical Device Regulation (EU MDR) represents a significant overhaul of the regulatory framework for medical devices...
Sep 24, 20236 min read
Navigating the EU MDR Labelling Requirements: A Comprehensive Guide
The European Union Medical Device Regulation (EU MDR) has ushered in a new era of regulatory compliance for medical device manufacturers....
Sep 23, 20235 min read
Regulation of Reusable Medical Devices under EU MDR
The introduction of the EU Medical Device Regulation (MDR) has brought increased emphasis on robust data and comprehensive evaluations...
Sep 22, 20234 min read
Understanding Systems and Procedure Packs in Accordance with EU MDR
In today's healthcare system, the role of system and procedure packs is of great importance. Since these packs contain tools that are...
Sep 21, 20239 min read
Understanding the CE Marking Process for Medical Devices in the EU
The CE (Conformité Européenne) mark is a critical certification for medical devices seeking approval within the European Union. It...
Sep 18, 20234 min read
Regulation of Reprocessed Single-Use Devices (SUD) under EU MDR
"Reprocessing" denotes a series of procedures conducted on a previously used device to enable its safe reuse. This encompasses cleaning,...
Sep 17, 20238 min read
Reprocessing Single-Use Devices in accordance with EU Medical Device Regulations (EU MDR 2017/745)
Single-Use Devices (SUDs) are indispensable in the healthcare sector, providing essential tools for medical procedures. While SUDs are...
Sep 16, 20235 min read
Conformity Assessment of Medical Devices under EU MDR
The world of medical devices is a realm of constant innovation, where the development of new technologies has the power to transform...
Sep 15, 20234 min read
UK Responsible Person (UKRP): Obligations for Medical Device Manufacturers Outside the UK
For medical device manufacturers located outside the United Kingdom (UK) without local business offices, it is mandatory to designate a...
Sep 9, 20232 min read
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