“Unachievable Deadlines” – The EU’s Team-NB Calls for New Guidance on Allowing Remote Audits
Author: Stacie Beecham Resource constraints facing global manufacturers are also being felt by Notified Bodies (NBs) across Europe, due to the additional requirements imposed by the new MDR/IVDR Regulations. Team-NB, […]
New Guidance Templates for the Post-Market Clinical Follow-Up (PMCF) Plan and PMCF Evaluation Report
Author: Suzanne Broussard The newest guidance documents for post-market clinical follow-up (PMCF) requirements have just been released by the Medical Device Coordination Group (MDCG). The two documents provide guidance templates for the PMCF plan and the […]
Does Your Organization’s Post-Market Clinical Follow-Up (PMCF) Plan Adequately Reflect the Intensity Required in the Clinical Evaluation Report (CER) Under the Newest Medical Device Regulations?
Author: Suzanne Broussard Post-market clinical follow-up (PMCF) requirements have increased under the newest Medical Device Regulations (MDR) 2017/745. All medical devices will be required to meet these standards, and the deadline is here. The possible […]