MDR – UDI Requirements (Annex VI – Part C)
11 November, 2021 MDR – UDI Requirements What is UDI? Unique Device Identifier (UDI) is a series of numeric or…
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Post Market Surveillance – MDR Chapter 7 Vigilance Requirements
02 September, 2021 One of the biggest challenges during MDR transition is to understand what brings new regulation to post…
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MDR – Article 17 – Single-Use Devices and Their Reprocessing
16 July, 2021 With MDR, the reprocessing of single-use devices (MDR Article 17) have also entered our lives. This issue…
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MDR – Article 10 – General Obligations of Manufacturers
08 April, 2021 Whereas old Medical Device Directive has these obligations but new Medical Device Regulation has new ones that…
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MDR Chapter 7 Vigilance Requirements – Reporting of Serious Incidents
10 March, 2021 Nobody wants a medical device that they manufacture to harm a person or result in death. The…
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MDR Article 15 – Person Responsible for Regulatory Compliance
18 January, 2021 If you are not a small company, you might ask yourself: “Shouldn’t we have already a responsible…
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MDR Article 11 – Authorised Representative
18 January, 2021 All “non-EU” medical device manufacturers should have an authorised representative, if they want to sell their products…
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Pandemics and Single Use Devices
19 March, 2020 In this article, we’ll try to explain to you Pandemics and Single Use Devices. Click here for…
