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COVID-19: How IMed is Supporting the Industry

COVID-19: How IMed is Supporting the Industry

Here at IMed, our Quality & Regulatory Consultants have been busy adapting to the challenges which face us all, during this difficult time. Adaptation is a vital tool for any business in such an unprecedented commercial landscape. But it’s actually been great to...

How Should We Classify Our IVD Device under the IVDR?

How Should We Classify Our IVD Device under the IVDR?

As the manufacturer of legacy IVD devices, you face the challenge of reclassifying your product portfolio using the new risk-based classification rules, outlined in Annex VIII of the IVDR 2017/746.  There are still some grey areas, which I shall clarify during this...