JD Supra

EU MDR And IVDR Implementation: Signs Of Relaxing Transitioning Regime And Bridging Measures

Due to the grave shortage of notified body capacity and the sheer amount of medical devices and in-vitro medical devices (IVD), which need to be recertified under the new legislative framework, most ...
JD Supra

Medical Devices in the EU: MDD Certificates Remain Valid - the EU Extends Transition Periods for MDR Compliance, and Sell-Off Dates for Devices Under MDD and IVDD Fall Away!

Today, on Monday, March 20, 2023, Regulation (EU) 2023/607 of the European Parliament and of the Council of March 15, 2023, amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards transitional ...
News Medical

Medical devices and EU laws

Since the 2017 publication of the medical device regulation (MDR) and the IVD regulation (IVDR), EU regulations for medical devices and IVDs have undergone a profound change. Manufacturers are now ...
Nasdaq

ReShape Lifesciences Achieves EU MDR and UKCA Certification for Medical Devices, Enhancing Patient Safety and Market Access in Europe

ReShape Lifesciences has achieved EU MDR and UKCA certifications for its medical devices, enhancing market access and ensuring safety compliance. ReShape Lifesciences announced that its Quality ...