Europe – User guide for micro, small and medium-sized enterprises
This guide has been prepared for micro, small and medium sized enterprises (‘SMEs’) operating in the pharmaceutical sector. Its aim is to facilitate understanding...
Europe – Transition to MDR underway for 63% of outgoing Directives certificates
The number of applications for certification under the Medical Device Regulation (MDR) almost doubled to 9,615 last year, according to a survey of notified...
UK – Artificial pancreas technology set to change lives
Individuals who are typically unable to manage their type 1 diabetes will be offered new technology to help them control their condition. Furthermore, the...
USA – FDA criticized for approval of genetic test for opioid addiction risk
Physicians and public health advocates are urging the US Food and Drug Administration (FDA) to revoke its approval of AvertD to predict the potential...
Israel – New study use musical tests for early detection of cognitive decline
“Our method enables routine monitoring and early detection of cognitive decline in order to provide treatment and prevent rapid, severe deterioration,” said the researchers...
USA – Remote regulatory assessments: Pharma, device groups want more details on FDA guidance
Trade groups representing the pharmaceutical and medical device industries, while largely supporting the use of remote regulatory assessments (RRAs) as outlined in the US...
Europe – Notified bodies’ paper on the application of hybrid audits to quality management...
Team-NB would like to emphasise that we do not regard this document as final rule or guidance, but rather as our view/expectation for the...
Europe – Amendement des normes IEC 60601 : les impacts sur l’évaluation des DM
Publiée pour la première fois en 1977, la norme IEC 60601-1 décrit les exigences générales de sécurité et de performances applicables aux dispositifs électro-médicaux....
Europe – 38ème organisme notifié au titre du Règlement 2017/745
38ème organisme notifié au titre du Règlement 2017/745
UK – Medical devices: UK approved bodies
UK approved bodies listed under Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002)...
