2019 Round-up & What’s upcoming in 2020

As we close the year of 2019, let’s look at the most interesting stories of the past year and look forward to what’s installed in the start of the new decade.

  • United States urged the European Union to push back the MDR deadline by 3 years despite the EU commissioner for health making the statement that the deadline will not be adjusted.
  • European Commission and Medical Device Coordination Group also released several MDR guidance documents on persons responsible for regulatory compliance and implant cards.
  • FDA issued a total of 10 PRVs in 2019 which included the latest Merck’s Ebola vaccine. So companies can now sell the vouchers and use them to speed the review of new treatments.
  • UK pushing back BREXIT to the end of January 2020 saw the UK’s Medicines and Healthcare products Regulatory Agency releasing a series of guidance documents to help pharmaceutical and medical device companies.

Looking ahead to 2020, we would see:

  • Several important FDA rules being made and new guidance documents.
  • A better understanding on how BREXIT is impacting drug and device supplies in the UK.
  • FDA to release 2 revised draft guidance on the post market surveillance of devices and post-approval studies.