Italy – The New Italian Sunshine Act: What Companies Should Know And How To...

On 31 May 2022, the Italian Parliament approved Law 62/2022, also known as the Sunshine Act.  The Sunshine Act entered into force on 26...
DEKRA accredited under the MDR

Europe – European Notified Body survey: MDR, IVDR certification numbers remain low

A new survey from the European Commission shows that many medical device and in vitro diagnostic (IVD) manufacturers have yet to apply for certification...
DEKRA accredited under the MDR

Europe – European Parliament votes to extend MDR transition period

The European Parliament on Thursday voted overwhelmingly to extend the Medical Devices Regulation (MDR) transition periods to avoid a shortage of life-saving products in...

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