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- FDA to release 2 revised draft guidance on the post market surveillance of devices and post-approval studies.