The must-know clinical evaluation requirements

White Paper

Full compliance to both the MEDDEV and MDR is expected by May 26th 2024, so we’re outlining the key differences manufacturers need to pay attention to ahead of the transition – ensuring both legacy and new products are compliant.

Download your copy of our whitepaper below…

Since the breast implants scandal, there’s been an increased focus on establishing a robust, transparent, predicable, and sustainable regulatory framework for medical devices. While device safety remains at the forefront of the medical industry, the changes to regulations also represent an increased focus on combining safety with device innovation. Want to prepare for the changes in the best possible way? Download our whitepaper to learn about:

  • The key differences between MEDDEV 2.7/1 revision 4 and MDR 2017/745 regarding clinical evaluation
  • The potential deficiencies for approved products that must transition, and the need to prepare retrospective technical documentation
  • The associated actions that legal manufacturers must take to achieve regulatory compliance

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