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Medical Device

September 30, 2021

Schlafender Hase Team

Medical Devices Regulation EU 2017/745

Medical Devices Regulation (MDR) updates represent a step towards higher labeling standards.

September 22, 2021

Schlafender Hase Team

MDR UDI and Device Registration

The new European Database on Medical Devices, known as EUDAMED, was originally scheduled to launch in May 2020,

March 16, 2021

Schlafender Hase Team

The EMA and TVT

This may come as a surprise to regulatory affairs professionals of the pharmaceutical industry, but the European Medicines Agency (EMA) has been using TVT, the Text Verification Tool® since 2004!

July 25, 2019

Schlafender Hase Team

Are You a Medical Device Manufacturer?

The regulation on medical devices 2017/745, widely known as the EU MDR, was released in May 2017 with regulation 2017/746 on in vitro diagnostics. EU MDR and regulation 2017/746 replaced Council Directive 93/42/EEC, also known as the Medical Device Directive (MDD), and Directive 98/79/EC on in vitro diagnostic medical devices.

June 13, 2018

Schlafender Hase Team

Medical Device Recalls

The majority of medical device recalls are due to labeling or software - HMI issues. TVT can help keep you from becoming a statistic.