Medical Device Sterilization is a key aspect of ensuring certain Medical Devices are safe and effective. Sterilization ensures that the medical device is free from microorganisms before they are used on patients. Reducing the risk of infections.
Medical Device Sterilization Read More »
Software as a Medical Device (SaMD) has fundamentally changed the clinical landscape. From AI-driven diagnostic image scanning to standalone smartphone apps used for real-time clinical decision-making, digital health tools are scaling faster than ever. However, understanding exactly how SaMD is regulated, classified, and maintained is critical to securing market access under current MHRA and EU Notified Body expectations.
Software as a Medical Device (SaMD): Regulatory & Development Guide Read More »
Post Market Clinical Follow-up of medical devices is an important part of Post Market Surveillance. It is the process of monitoring devices in the real world environment.
Post Market Clinical Follow-up – Medical Devices Read More »
Learn how post-market surveillance (PMS) helps medical device manufacturers monitor safety, collect real-world evidence, maintain MDR compliance and improve devices throughout their lifecycle.
Post-Market Surveillance (PMS) for Medical Devices Read More »
Learn how medical device clinical evaluation demonstrates safety, clinical performance and regulatory compliance under the EU MDR and UK medical device regulations. This guide explains the Clinical Evaluation Plan (CEP), Clinical Evaluation Report (CER), clinical evidence requirements and post-market obligations.
Medical Device Clinical Evaluation Read More »
ISO 14971 is the global standard for managing risks in medical devices, guiding manufacturers through identifying, evaluating, and mitigating risks throughout the product lifecycle.
ISO 14971 and the Risk Management of Medical Devices Read More »
The UKRP must provide written evidence that they have the manufacturer’s authority to act as their UK Responsible Person. Importers and distributors are not required to appoint a UK Responsible Person.
The UKRP acts on behalf of the non-UK manufacturer to carry out specified tasks in relation to the manufacturer’s obligations. As noted above, this includes registering the manufacturer’s devices with the MHRA before the devices can be placed on the UK market.
UK Responsible Person (UKRP) – Medical Devices Read More »
In healthcare, ensuring the safety and efficacy of medical devices is paramount. Patients rely on these devices for diagnosis, treatment, and improved quality of life. Biological evaluation plays a pivotal role in determining the biological safety of these devices. Governed by international standards, most notably the ISO 10993 series, biological evaluation involves a thorough assessment of a device’s interaction with living tissues. This blog delves into the importance of biological evaluation, highlighting the critical biological endpoints outlined in ISO 10993, the significance of a robust biological evaluation plan, and the crucial role of qualified experts in this process.
The Biological Evaluation of Medical Devices Read More »
The CE marking of medical devices and in vitro diagnostic devices (IVDs) is a requirement of EU regulations (EU 2017/745 for medical devices and EU 2017/746 for IVDs) to lawfully place medical devices on the EU market. Manufacturers must affix the CE mark on the medical device or IVD itself and on the primary packaging (or just on the packaging if affixing to the device itself it not possible). The CE mark should also be placed on any instructions for use and any labelling. The use of the CE mark identifies that a medical device or IVD conforms to EU regulatory requirements and is a symbol that a device meets safety standards.
CE Marking Medical Devices Read More »
When developing a new and exciting product it can be hard to know if it might fall under specific regulations. This is usually the case with medical devices. The medical device industry is highly regulated worldwide. These regulations have specific criteria that determines if a product falls under the definition of a medical device. Therefore it is really important to evaluate your product to see if it might be in the scope of these medical device definitions for the regulation of the countries in which you wish to sell the product in.
Is My Product a Medical Device? Read More »
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