The Medical Devices Introductory Course 2020

Post Market Surveillance

ISO 14971:2012

•

“The risk management plan should include documentation of decisions, based on a risk analysis, about what sort of post market surveillance is appropriate for the device, for example, whether reactive surveillance is adequate or whether proactive studies are needed” (F7)

The Organisation for Professionals in Regulatory Affairs

Post Market Surveillance

Regulatory requirements – Medical Device Regulations (26 May 2021) New regulations significantly reinforces health and safety of patients and users:- MDR 2017/745, Article 10.. section 9 “The QMS shall address at least… Setting up, implementation and maintenance of a PMS system in accordance with Article 83” section 10 “Manufacturers of devices shall implement and keep up to date the PMS system in accordance with Article 83” •

The Organisation for Professionals in Regulatory Affairs