Category: Medical Device

Medical Devices USA/Europe Regulatory Updates round up, Jul 2021

August 4, 2021
Medical Device

EUROPE 1. First references of harmonised European standards in support of Regulation (EU) 2017/745 published in the OJEU: Commission Implementing Decision (EU) 2021/1182 of 16 July 2021 In accordance...

Clinical Outcome Assessments (COAs) in Medical Device Decision Making

June 23, 2021
Medical Device

A clinical outcome assessment (COA) describes or reflects how a person feels, functions, or survives and can be reported by a health care provider or a non-clinical observer (such as a parent), through...

clinical outcomes assessment in devices, Clinician reported outcomes (ClinROs), Observer reported outcomes (ObsROs), Patient-reported outcomes (PROs), Performance outcomes (PerfOs)

Unique Device Identification System

May 13, 2021
Medical Device

The FDA established the unique device identification system to adequately identify medical devices sold in the United States from manufacturing through distribution to patient use. When fully implemented,...

FDA requires medical device labelers, GUDID, Medical Devices, Medical Devices Labeling, UDI, Unique Device Identification System

Medical Device Labeling under FDA

March 23, 2021
Medical Device

Food and Drug Administration (FDA) puts forth certain regulations in the U.S. that are abiding on food, drugs, medical devices, biologics, cosmetics and even radiation emitting electronic products....

FDA Labeling Requirements, Labeling requirements for Medical Devices, Medical Device Labeling, medical device labeling requirements, medical device labels, Medical device regulatory requirements

FDA Issues New Enforcement Policy for Sterilizers, Disinfectant Devices, and Air Purifiers during COVID-19 Emergency

April 2, 2020
Medical Device

FDA issued this guidance to provide a policy to help expand the availability and capability of sterilizers, disinfectant devices, and air purifiers during this public health emergency. The Agency...

European Medicines Agency Issued Electronic Certificates for Medicines

April 2, 2020
Medical Device

European Medicines Agency (EMA) has implemented a new system to issue electronic certificates for human and veterinary medicines. As of today, the Agency will no longer provide printed certificates...