The Medical Device Coordination Group issued a guidance on how to place ventilators on the EU market during the Covid-19 pandemic. Find out all the details.
Medical devices and healthcare
Coronavirus: special measures and ban on rapid self-tests in Belgium
Obelis can still assist you in quickly submitting all the other IVDs that are critical for addressing the COVID-19 outbreak!
MDR Delay: which provisions have been changed?
1-year delay will provide you with additional 12 months to finalize your compliance with the MDR, which is a complex and lengthy process!
New 2020 lists of harmonised standards for medical devices made available
These harmonized standards are drafted to presume compliance with the essential requirements they cover in support of the following legal acts.
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We Create Compliance for Safer Markets Discover the industries we cover and the compliance routes…
MedTech Europe and European Commission approach on EU ArtificiaI Intelligence and Data strategy
Medical device manufacturers are using these technologies to innovate their products to better assist healthcare providers and improve patient care.
Do you want to place your 3D printed product on the EU internal market to be used in a medical context and fight against COVID-19?
Is there any applicable EU legal framework in the case of 3D printing?
COVID-19: Free European standards and easier MD & IVD registration
Europe adopts new measures to respond to COVID-19 outbreak, including measures to speed up MD & IVD device EU market introduction and free info on EU standards.
Withdrawal of notified body services: MHRA takes over
Updates from the Medicines and Healthcare Products Regulatory Agency on the withdrawal of several UK-based notified bodies.
Joint implementation plan on the new Medical Devices Regulation – (EU) 2017/745 (MDR)
With the 26 of May around the corner, and as response to the call from the Council of the EU (EPSCO), the MDCG (Medical Device Coordination Group) has issued a document stating the challenging joint responsibility Member States and the Commission have, together with the concerned stakeholders, to ensure that the new legislation on medical devices is operational from the aforesaid date.