Post the Brexit scenario, the Regulatory landscape for medical devices in the United Kingdom (UK) underwent a profound metamorphosis, significantly impacting manufacturers aiming to introduce their products. As the UK made an exit from the European Union (EU), there was a shift from Conformité Européenne (CE) marking to UK Conformity Assessed (UKCA) marking.
- March 29, 2024 Medical Devices, Regulatory Affairs
- March 29, 2024 Medical Devices, Regulatory Affairs
The current Regulatory scenario for medical devices in the United Kingdom (UK) is governed by the Medical Devices Regulations 2002 (SI 2002 No. 618, as amended), also known as the UK MDR 2002.
- March 29, 2024 Medical Devices, Regulatory Affairs
The specifics for medical devices refer to a set of technical and/or clinical requirements, other than a standard, that provides a means of complying with the legal obligations applicable to a device, process, or system. This includes the type of medical conditions the device is designed to diagnose, treat, monitor, alleviate, or prevent.
- March 29, 2024 Medical Devices, Regulatory Affairs
In the ever-evolving healthcare landscape, personalized medical devices have emerged as a groundbreaking approach, tailoring treatments to individual patients based on their unique characteristics. These include devices that are custom-made or personalized to be adaptable to the patients’ solutions.
- March 29, 2024 Medical Devices
While placing your medical device on the European Union (EU) market, obtaining CE marking is a mandatory step. This is essential to assure the end user that the devices available in the market are both safe and effective for use. A critical component for providing this assurance involves a thorough examination of the technical documentation for the medical devices.
- March 28, 2024 Publishing & Submissions, Regulatory Software & Services
The global race to bring new drugs and medical devices to market has fuelled the rise of parallel submissions – a strategy where companies file applications with Regulatory agencies in multiple countries concurrently. A recent study by Tufts Center for the Study of Drug Development found that parallel submissions for new drugs can reduce approval timelines by an average of 9 months.
- March 27, 2024 Pharmaceuticals, Regulatory Medical Writing
In the realm of pharmaceuticals, one of the critical aspects of ensuring safety is the implementation of child-resistant packaging (CRP). This blog post delves into the importance of CRP and its relevance to medical writing, a field that plays a significant role in communicating drug information effectively.
- March 27, 2024 Pharmaceuticals, Regulatory Medical Writing
Clinical trial transparency is an integral component of ethical research conduct and encompasses the dissemination of comprehensive trial details and results to a diverse array of stakeholders, including the public, patients, healthcare professionals, and researchers.
- March 18, 2024 Pharmaceuticals, Regulatory Affairs
The life sciences industry is undergoing a seismic shift, with automation and artificial intelligence (AI) transforming the landscape of Regulatory affairs. As we look towards 2025, the integration of these technologies is not just a trend but a fundamental change in how companies approach compliance and drug development.
- March 18, 2024 Pharmaceuticals, Regulatory Affairs
Falsified medicines pose a significant threat to public health, undermining trust in the healthcare system and jeopardizing patient well-being. Recognizing the gravity of this issue, the European Union (EU) has implemented a multifaceted strategy to combat the distribution and marketing of falsified medicinal products within its member states.