France – Comment apporter une preuve clinique suffisante pour se conformer au RDM ?
Le Règlement 2017/745 (RDM) a considérablement augmenté la place des données cliniques dans le processus de certification des Dispositifs Médicaux (DM), en comparaison des...
USA – FDA will begin accepting breakthrough devices for TAP pilot in 2023
The US Food and Drug Administration (FDA) will start accepting products into its total product lifecycle advisory program (TAP) pilot starting in January. The...
Europe – European Notified Body survey: MDR, IVDR certification numbers remain low
A new survey from the European Commission shows that many medical device and in vitro diagnostic (IVD) manufacturers have yet to apply for certification...
International – IMDRF publishes updated guides covering governance activities and membership
The International Medical Device Regulators Forum (IMDRF) recently posted a series of updated guidelines on the group’s standard operating procedures (SOP), criteria for joining,...
Europe – European Parliament votes to extend MDR transition period
The European Parliament on Thursday voted overwhelmingly to extend the Medical Devices Regulation (MDR) transition periods to avoid a shortage of life-saving products in...
International – Diabète : un pansement intelligent pour soigner et cicatriser les plaies chroniques
Les plaies chroniques dites « non cicatrisantes » concernent des dizaines de millions de personnes dans le monde. Ainsi, de 15 % à 25 % des patients diabétiques...
UK – Medical devices: UK approved bodies
Approved bodies under Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002) for medical devices...
USA – US FDA withdraws COVID-era guidance for medical device and IVD market approval...
The US Food and Drug Administration announced that it has withdrawn its temporary policies related to the COVID-19 pandemic because they are no longer...
Singapore – Singapore adds HIBCC to list of UDI issuing agents
Singapore’s medical device market regulator, the Health Sciences Authority (HSA), has announced that a new designated issuing agency (IA) has been added to its...
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...
