The landscape of medical device software regulation has evolved dramatically since the introduction of the Medical Device Regulation (MDR). With software increasingly becoming the backbone of modern healthcare technology, understanding how to properly classify and regulate these digital tools has become essential for manufacturers, developers, and regulatory professionals alike. The MDCG 2019-11 guidance document represents a crucial milestone in this journey, providing much-needed clarity on software classification requirements under the MDR framework. This comprehensive guidance addresses a fundamental question that has challenged the industry: how do we determine when software qualifies as a medical device and what regulatory obligations follow? […] […]
Category: Quality and regulation
How often should audits be conducted in a health technology company?
The frequency of audits in a health technology company is primarily determined by the requirements of the ISO 13485 standard and the MDR/IVDR regulations. Internal audits must be conducted in accordance with the audit plan defined in the quality management system. External audits performed by a notified body are carried out annually. The regularity of audits ensures the functionality and compliance of the quality management system. […]
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EU4MEDTECH – Transforming Medical Technology Evaluation
European health technology development is undergoing a transition, and new regulatory requirements are challenging companies to find effective solutions. Clinipower is participating in the EU project EU4MEDTECH, which is advancing the development of health technology. EU4MEDTECH Project – Transformation of Medical Technology Evaluation EU4MEDTECH is a 4-year Horizon Europe project that develops the evaluation and […]
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IVD Regulation is coming – are you ready?
Thursday 26th of May 2022 is a significant day for those operating with in vitro diagnostic (IVD) medical devices in the European Union (EU). This is the date of application of the new EU Regulation 2017/746 on in vitro diagnostic medical devices (IVD Regulation, IVDR), from which the Regulation will be fully applicable, taking into […]
Software in the medical device field – definition and risk classification according to the MDR
The image that pops into mind when hearing the term “medical device” often has something to do with physical devices or machines, such as x-ray machines or pacemakers. In addition to these, however, software is an increasingly important part of the medical device spectrum, both as stand-alone devices and as part of other devices. As […]
