If you are a manufacturer of medical devices or in vitro diagnostic (IVD) devices based outside Swit...
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For medical device and in vitro diagnostic (IVD) manufacturers located outside the United Kingdom, a...
For medical and in vitro diagnostic device manufacturers based outside the European Union, accessing...
Under the EU Medical Device Regulation (MDR), usability is no longer a ‘nice-to-have’—it’s a core co...
In-silico testing — using computational modeling and simulation techniques — has rapidly become an i...
Cybersecurity has become a fundamental requirement under the Medical Device Regulation (MDR). Medica...
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With the introduction of the Medical Device Regulation (MDR), the requirements for placing medical d...
With the Medical Device Regulation (MDR 2017/745) being more stringent than the previous European Me...
Medical Devices CE certified under the European Medical Device Directive (MDD) or the Active Implant...
The rules outlined in the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) ...
Conformity assessments for CE approval As indicated on the website of the European Commission, a med...
In June 2022, concerns were expressed that severe challenges related to the implementation of Regula...
Annex XVI of the MDR EU 2017/745 lists products (6 categories) without an intended medical purpose t...
The European Parliament has adopted the proposal to extend the transitional period for legacy device...
PRRC: meaning of this new role under MDR and IVDR The Person Responsible for Regulatory Compliance o...