Tag: EU MDR

What Pharma Companies need to know about EU MDR Regulations?

July 6, 2023
Biopharma

EU MDR The Medical Device Regulation (MDR), which was adopted in April 2017, changes the European legal framework for medical devices The EU MDR entered into application on 26 May 2021 REGULATION...

Compliance, EU MDR, Medical Device Regulations, Pharmaceutical Industry, Regulatory Affairs

Medical Device Labelling Requirements

February 13, 2023
Medical Device

The safe operation of a medical device must never come down to guesswork or trial and error. Informative, accurate labeling is required, and every label included with the device has to meet the applicable...

Code of Federal Regulations, EU MDR, General Device Labeling, In Vitro Diagnostic, Medical Device Labelling, Medical Device Regulation, Unique Device Identification, US FDA

EU MDR Regulations

November 22, 2022
Standards

Regulation (EU) 2017/745 is a regulation of the European Union on the clinical investigation and sale of medical devices for human use. It repeals Directive 93/42/EEC, which concerns medical devices,...

EMA, EU MDR, EU MDR Regulations, EUDAMED, MDR

Clinical and Performance Evaluation under EU-MDR – New CE Market Rules

August 5, 2021
Standards

Clinical evaluation of medical devices is a systematic and planned process that contributes to the continuous generation, collection, analysis and evaluation of clinical data on a particular device....

clinical and performance evaluation, clinical trial Requirements, EU MDR, FDA clinical trial Regulations, Medical Device clinical Investigation Requirements, new ce market rules