Jan 14, 2021
EU MDR/IVDR
The Notified Body Operations Group (NBOG), an organization established by the European Commission to improve the performance of notified bodies earlier in 2000, has published a best practice guide dedicated to the designation and notification of conformity assessment...
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Dec 30, 2020
EU MDR/IVDR
The Notified Body Operations Group (NBOG), an organization established by the European Commission to improve the performance of notified bodies earlier in 2000, has published a best practice guide dedicated to the designation and notification of conformity assessment...
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Dec 2, 2020
EU MDR/IVDR
The European Commission (EC), a union-wide authority responsible for medical devices regulations, has announced the launch of the first of six EUDAMED modules – the Actor registration module. Intended Purpose According to the official announcement published by...
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Sep 3, 2020
EU MDR/IVDR
The Medicines and Healthcare products Regulatory Agency (MHRA) has published detailed guidance dedicated to the new regulations that will take effect from January 1, 2021. Starting from the aforementioned date, the authority would be fully responsible for all...
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Sep 1, 2020
EU MDR/IVDR
The Medical Device Coordination Group (MDCG) has published a Q&A dedicated to conformity assessment procedures for protective equipment. The document has been developed to provide the manufacturers and other parties involved with additional information to achieve...
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