Regulations
MHRA Guidance on Stand-alone Software Medical Devices
Medical device apps are increasingly growing these days. MHRA has issued new guidance on the stand-alone software medical devices, including apps. This guidance is a crucial document for manufacturers and users of such medical devices.
Article 61 Clinical Evaluation in the EU MDR
Manufacturers must plan, carry out, and document a Clinical Evaluation in order to comply with the general safety and performance standards outlined in Annex I, as per Article 61. Clinical evaluation is a series of ongoing activities that use scientifically reliable techniques for the evaluation and analysis of clinical data in order to confirm the safety, clinical performance, and/or effectiveness of the medical device when used in accordance with the manufacturer’s instructions.
The ‘Blue Guide’ on EU product rules implementation 2022
The amended ‘Blue Guide’ on the application of the product rules 2022’ (“Blue Guide”) was released by the European Commission on June 29, 2022. The Blue Guide allows a better understanding of EU product regulations and their uniform and coherent application across...
Risk Management of medical devices under MDR
All medical devices are associated with inherent risks of some level. It is imperative to understand the medical device's specific risks to a patient. Under EU MDR 2017/745, risk management is a continuous and iterative process. Manufacturers are expected to plan,...
Cybersecurity for Medical Devices – FDA and EU MDR Perspective
Medical devices and the software of those devices are connected to several types of networks. Therefore, it is particularly important for manufacturers to consider Cybersecurity at the initial stages of the development.
Cybersecurity for medical devices in Europe
Cybersecurity for Medical devices is advancing, and the use of software medical devices is also increasing daily. The increased interconnection of medical devices to computer networks and technological convergence have made devices and software programmes vulnerable to mishaps. With the advancement of software as a medical device, proper regulations must establish the safety and security of medical devices.
IMDRF Regulation on SaMD
IMDRF Regulation on SaMD: As more businesses see the benefits of utilizing their software development knowledge for the benefit of patients throughout the world, the market for software as a medical device (SaMD) is expanding quickly.
Requirements of Technical Documentation EU MDR
The technical documentation shall be presented in a clear, organised, readily searchable and unambiguous manner. It shall include all the elements listed in Annex II of EU MDR.
Exceptional Use Medical Devices in the EU and UK
Medical devices that conform to regulations require a conformity marking. Exceptional use medical devices are those that do not comply with regulations of a particular country and do not require a conformity mark. These medical devices may not conform to applicable regulations, but they could still potentially protect patient health.
Smart Wearables Regulations in the EU
Smart wearables technology is gearing up to great potential and becoming a part of our daily lifestyle. While most of them are claimed to fall under general wellness equipment, there is a rising concern about how these devices are regulated in terms of safety without falling under the stringent medical device regulations.