Aug 26, 2020
EU MDR/IVDR
The European Commission (EC), a legislative body of the European Union, has adopted a regulation dedicated to the common specifications for the reprocessing of single-use devices. Regulatory Background The new Commission Implementing Regulation (EU) 2020/1207 is...
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Aug 24, 2020
EU MDR/IVDR
The European Commission (EC), the EU regulating authority in the sphere of medical devices, has published a detailed FAQ dedicated to the most important questions related to the Unique Device Identification (UDI) system established under the Medical Device Regulation...
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Aug 21, 2020
EU MDR/IVDR
The Medical Devices Coordination Group (MDCG) has published special guidance providing medical device manufacturers and other parties involved with additional recommendations and clarifications regarding how Article 15 of the Medical Device Regulation 2017/745 (MDR)...
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Aug 13, 2020
EU MDR/IVDR
The Medical Device Coordination Group (MDCG), an advisory body of the European Commission, has issued the first revision of guidance notes to the manufacturers of Class I medical devices initially published in December 2019. In particular, the document intends to...
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Jul 9, 2020
COVID-19
The European Commission (EC), the European body responsible for medical device regulation, published a summary dedicated to the availability and capacity of notified bodies to perform the conformity assessment of medical devices and in vitro diagnostic medical devices...
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