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Tag Archives: eu

UK SME readiness for the EU Medical Device Regulation

The EU Medical Device Regulation (MDR) is now law. The transition period will finish in just 9 months whereupon any CE marked medical device will need to conform to the requirements of the regulation or risk being removed from the market with immediate effect. Large multinationals have been preparing for this moment for a number…
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Global Medical Device & IVD Regulations: What You Need to Know

With the implementation dates for the new EU Medical Device and IVD regulations looming (May 2020 & May 2022 respectively), companies are having to get their heads around the implications of greater levels of oversight for healthcare technologies where, for example, additional clinical evidence requirements are likely to impose a significant cost. Furthermore, the EU…
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