Blog Category: Medical Device

Medical Devices–USA/Europe Regulatory Updates Roundup, August 2022

Medical Device

EUROPE MDCG 2022-14 – Transition to the MDR and IVDR – Notified body capacity and availability of medical devices and IVDs The document has been endorsed by the Medical Device Coordination Group...

Medical Device Patient Information Leaflets and Implant Cards

Medical Device

From 1st December 2021, all Implantable and Active Implantable Medical Devices (AIMD) are required to hBeginning 1 December 2021, all Implantable and Active Implantable Medical Devices (AIMDs) must...

mdr implant card requirements, Patient information card, patient information leaflet mdr

Categorization and Registration Process for Devices in EUDAMED

Medical Device

Device Categorization Devices submitted for registration in EUDAMED fall under the following categories: Regulation Devices – These include medical devices and in vitro diagnostic (IVD) devices...

Categorization and Registration Process, Categorization of devices to be registered in EUDAMED, eudamed device registration, medical device labeling requirements, Registration Process for Regulation Devices

Guidance on Premarket Submission for Device Software Functions

Medical Device

This draft FDA guidance outlines the recommended documentation that should accompany premarket submissions containing device software functions. It applies to both software in a medical device (SiMD)...

FDA Medical Device clinical Regulations, fda submission guidance, guidance document pertain to device software functions, Guidance on premarket submission, Medical Device, software design specification medical device, software in a medical device

Medical Devices – USA/Europe Regulatory Updates round up – Sep 2021

Medical Device

EUROPE 1. Clarification on “first certification for that type of device” and corresponding procedures to be followed by notified bodies, in context of the consultation of the expert panel referred...

Europe, Europe FDA, Europe Medical Devices, Europe Regulatory Updates, FDA Updates, Medical quality, medicaldevice, Regulatory Updates, USA, Usa Medical Devices, USA Regulatory Updates

Infusion Pumps Safety Assurance

Standards

The FDA’s guidance, “Infusion Pumps Total Product Life Cycle,” provides recommendations for preparing premarket submissions for infusion pumps and identifies device features that manufacturers should...

Elastomeric infusion pump, Enteral infusion pump, Infusion pump, Infusion pump accessories, Infusion Safety Management Software, Insulin bolus infusion pump