Jun 19, 2020
EU MDR/IVDR
The European Commission (EC), the medical device regulating authority of the European Union, issued a new regulation regarding standardization aspects in the context of Medical Devices Regulation 2017/745 (MDR) and In Vitro Diagnostic Medical Devices Regulation...
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Jun 8, 2020
Europe
The European Commission (EC), the EU authority responsible for medical devices regulation, issued a Q&A conformity document describing the approaches to verifying that medical devices and personal protective equipment (PPE) are allowed to be marketed and uses...
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May 28, 2020
EU MDR/IVDR
The Medical Device Coordination Group (MDCG), an advisory body of the European Commission focused on the improvement of the regulatory framework in the sphere of medical devices, issued guidance dedicated to the safety reporting in clinical investigations under the...
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May 27, 2020
EU MDR/IVDR
The European Commission (EC), the EU body focused on the improvement and development of medical devices regulation, issued guidelines describing the way the EU-wide derogations for medical devices should be applied under the Medical Devices Regulation 2017/745 (MDR)....
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May 25, 2020
EU MDR/IVDR
The European Commission (EC), the EU body responsible for medical devices regulatory framework, announces amendments to the designation procedures related to the Notified Bodies (NBs), and also to the rules on the EU-wide derogations. EC New Regulations in Brief Both...
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