Nov 6, 2019
Europe
The Health Products Regulatory Authority (HPRA) of Ireland has shared details of its efforts to mitigate the risk of disrupting the supply of medical devices caused by a no-deal Brexit. In cooperation with the Department of Health and the Health and Safety Executive...
Read More
Oct 17, 2019
EU MDR/IVDR
The Medical Device Coordination Group (MDCG), a special advisory body of the European Commission (EC) issued a detailed guidance on software classification according to the new medical device regulations: 2017/745 (MDR) and 2017/746 (IVDR). Medical Software Regulated...
Read More
Jan 24, 2019
EU MDR/IVDR
The British Standards Institution (BSI) United Kingdom (UK) has been officially designated as the first notified body (NB) under the Europe Union’s (EU) new Medical Device Regulation (MDR). This is the first NB to be listed in the European Commission’s New Approach...
Read More
Jan 19, 2019
EU MDR/IVDR
The institution responsible for medical device regulations in Spain is Agencia Española de Medicamentos y Productos Sanitarios (AEMPS), a state agency within the Spanish Ministry of Health, Social Services and Equality. Spain, just like all the other members of the...
Read More