1-year delay will provide you with additional 12 months to finalize your compliance with the MDR, which is a complex and lengthy process!
News
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.
How is protective clothing regulated in the EU?
To find out more about how Obelis can help in making sure your protective products are compliant, talk to our team!
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Are you MDR/ IVDR compliant? Obelis endorses the information platform MDlaw.eu! Find all Medical Device…
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We Create Compliance for Safer Markets Discover the industries we cover and the compliance routes…
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Supporting Product Launch to the EU Market Discover the representation and technical services we offer,…
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?
How does Brexit affect the commercialization of your cosmetic products?
Learn more about the implications Brexit may have for the commercialization of your cosmetics products in the UK and EU markets.
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.