September 30, 2021
Schlafender Hase Team
Medical Devices Regulation EU 2017/745
Medical Devices Regulation (MDR) updates represent a step towards higher labeling standards.
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Medical Device
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.
