Introducing a New RAPS Member Benefit

Regulatory Focus (RF) Article
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The Regulatory Affairs Professionals Society (RAPS) is pleased to announce a quarterly series of electronic publications for RAPS’ Members only. The RF Article Series are comprised of timely and relevant Regulatory Focus technical articles, case studies, interviews and research reports.
These topic-focused collections are intended to benefit RAPS members responsible for healthcare related products. Articles are developed by global subject matter experts representing a wide range of regulatory responsibilities and organizations.

Transitioning to the New EU MDR and EU IVDR

Our second Regulatory Focus (RF) article series covers the fast-approaching implementation of the EU Medical Device Regulation (EU MDR) and EU In Vitro Diagnostic Device Regulation (EU IVDR).
RAPS has brought together leading global regulatory experts to share their valuable insights and practical experience on how to comply with the new EU MDR and EU IVDR. Compliance with these regulations will be essential for companies wishing to market medical devices and IVDs in the EU, including those already on the market. The regulations also have a significant impact for notified bodies. Authors address the challenges of the new regulations and offer their unique perspectives to implementation.

Individual articles examine:
  • specifics of the new regulations
  • ​steps toward EU MDR and EU IVDR implementation
  • a new authority under the regulations
  • challenges of meeting the new requirements
  • CE marking
  • possible shortfall of IVDR-designated notified bodies
  • presentations from the RAPS EU MDR/IVDR workshop
  • and more
Other topics to be covered in 2018 include:

To Access Your Member Benefit, simply login and select the e-Book: Transitioning to the New EU MDR and EU IVDR in the Member Knowledge Center.

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