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Regulatory headaches: Brexit's not the only thing you need to worry about

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  • 3 Pages
  • September 2022
  • Region: Global
  • Pharma Intelligence
  • ID: 4775376
Brexit may be overshadowing other EU regulatory concerns right now, and that’s understandable: A no-deal Brexit would dramatically affect regulatory alignment and trade, and even at this late date it’s unclear how the issue will be resolved.

It’s far from the only challenge the medtech industry, however. This article explores several EU regulatory concerns and their implications for the industry. For example, lack of progress and clarity in the new Medical Device and IVD Regulations are creating considerable uncertainty, and many are still coming to terms with the General Data Protection Regulation - more commonly known as GDPR - which went into effect May 25.