USA – FDA adds transition period to electromagnetic compatibility final guidance
The US Food and Drug Administration (FDA) has finalized guidance on medical device electromagnetic compatibility that replaces a 2016 document on the same topic....
France – Un risque réel de pénurie de Dispositifs Médicaux
Les Académies nationales de médecine, pharmacie et chirurgie alertent sur un risque de pénurie de DM et DMI en raison des difficultés de mise...
USA – Experts call for data transparency with recalled medical devices
Over the last few years, some patients have been receiving implantable cardioverter-defibrillators (ICDs) that are subject to Class I recalls. These devices have continued...
UK – Medical devices: EU regulations for MDR and IVDR (Northern Ireland)
This guidance provides information on the EU Regulations for medical devices (MDR) and in vitro diagnostic medical devices (IVDR).
From 1 January 2021 the Medicines and Healthcare...
Europe – MDCG 2022-8 Regulation (EU) 2017/746 – application of IVDR requirements to ‘legacy...
Regulation (EU) 2022/1121 extended the transitional provisions of Regulation (EU)
2017/746 on in vitro diagnostic medical devices (IVDR), in particular its Article 110(3),
in terms of...
France – LA HAS reconnait l’efficacité et l’utilité (ASA IV) du verre MiYOSMART (HOYA...
On observe une augmentation galopante de la prévalence de la myopie dans le monde, en grande partie due à un changement des activités au...
South Korea – South Korea updates regulations on medical device codes and classification
The Ministry of Food and Drug Safety (MFDS), South Korea’s medical device market regulator, issued a draft revision to Regulations on Medical Device Codes...
USA – Combination products: FDA finalizes list of CGMP alternatives, streamlined mechanisms
The US Food and Drug Administration (FDA) has released a finalized list of alternatives and streamlined mechanisms for current good manufacturing practice (CGMP) of...
USA – FDA warns device makers for GMP issues, unauthorized uses
The US Food and Drug Administration (FDA) recently warned a hemodialysis manufacturer for marketing their products without submitting a premarket notification for one of...
USA – FDA finalizes two more safety and performance based pathway guidances
The US Food and Drug Administration (FDA) on Tuesday published two more final safety and performance based pathway guidances for medical devices on the...
