Regulations

Article 61 Clinical Evaluation The MDR reinforces the clinical data and evaluation process (article 61 and Annex XIV), and the manufacturer must confirm the device’s conformity to fundamental health and safety requirements using reliable clinical data and evaluation. The clinical evaluation establishes the device’s safety and capacity to fulfil its intended function. It also evaluates adverse side effects and determines whether the benefit-risk ratio is acceptable. Manufacturers must plan, c...

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. In the UK, medical devices are subject to UKCA marking. The UKCA marking is no exception to software medical devices. Software Medical Devices or not Classifying software or a mobile app as a medical device can be challenging. If the software or app has a well-def...