What are the requirements for post-market follow-up (PMCF) studies in Canada?

... In Vitro Diagnostic Medical Devices (Directive 98/79/EC)]. Though this report is aimed principally at manufacturers of IVD medical devices, the concepts and ... Our medical device & IVD regulatory experts can help you gain a deep understanding of the applicable regulations and requirements. In vitro diagnostic medical devices are tests used on biological samples to determine the status of a person's health. The industry employs about 75 000 people ... “Modified Device” is a medical device(or an IVD) that is equivalent in 'Intended Use', 'Mechanism of Action(MoA)', 'Raw Materials(Limited to implanted/contacted ... May 26, 2021 ... ... IVDs. In 2017, the EU put into force its new regulations on medical devices and IVD. This development obligated the Swiss government to ... The role will also include auditing to EU MDR (EU medical device regulation 2017/745), UK MDR 2002 for medical devices and IVDs, ISO 13485 and MDSAP, ... Surmodics is a leading provider of chemical components for in vitro diagnostic tests and microarrays. We enable sensitive, reproducible, and robust diagnostic ... The In Vitro Diagnostic Devices Regulation applies since 26 May 2022. It repeals Directive 98/79/EC of the European Parliament and of the Council on in vitro ... Nov 13, 2024 ... In vitro diagnostics (IVD) are tests done on samples such as blood or tissue that have been taken from the human body. In vitro diagnostics (IVDs) are tests that can detect disease, conditions and infections. In vitro simply means 'in glass'.