Vigilance And Postmarket Surveillance: Companies Must Avoid Getting Caught Out By May 2021 Deadline
Executive Summary
There is no choice: manufacturers must start EU MDR compliance now, however incomplete implementation is. And some MDR clauses apply to all products as of May 2021, regardless of the grace period.
You may also be interested in...
Expert: Boost Compliance By Monitoring Social Media
IQVIA senior director Mike King recommends that companies use technology to watch social media platforms for reportable events as a way to both increase regulatory compliance and respond to safety signals more quickly.
Deadlines Needed For Urgent EU MDR Vigilance And Postmarket Surveillance Guidance Documents
Some 46 guidance documents still need to be drafted by the European Commission’s Medical Device Coordination Group before the EU MDR comes into force and time is running out, especially for postmarket responsibilities.
Second EU MDR Notified Body Designated In France
Four years after the designation of the first notified body in France under the Medical Device Regulation, AFNOR Certification has been named too.