PMS and Vigilance Training

Active and systematic collection, recording and analysis of data related data concerning the quality, performance and risklessness of a medical device throughout its economic life after it has been introduced into the market, determination, implementation and monitoring of corrective and preventive activities has become more important after the New Medical Device Directive (AB) 2017/745 has been carried into action. Related activities are carried out together with authorized agents, importers and distributors and have become a significant part of producer’s quality control system. Effective monitoring contributes to having access to the outputs of a PMS Plan that might reduce the risk of an adverse event. 

Purpose of the Training 

The training has been designed to help us understand the PMS and Vigilance process including legal requirements relating to the PMS and Vigilance processes and details relating to how to perform these processes. Practical activities and information exchange included within the scope of the training will contribute to the effective implementation of PMS and Vigilance Processes in your firm. 

Who should participate?

• Clinical Experts 
• Licensing Experts 
• Medical Device R&G Engineers 
• Medical Device Producers 
• Internal and External Auditors 
• Quality Managers 
• Development, Production and Marketing Managers 
• Medical Secretaries 
• Vigilance, PMS Officials 

Content of the Training 

• What the post-placement on the market monitoring system (PMS) includes 
• PMS requirements in MDR
• Preparation of the PMS plan 
• PMS report 
• Periodical safety report (PSUR) 
• Post placement in the market clinical follow-up (PMCF) plan and report 
• Post-sales monitoring responsibilities of firms with a certificate based on 93/42/EEC
• How to implement the vigilance process in MDR 
• Differences between MDD and MDR in the vigilance process 
• Trend Reporting 
• Reporting of adverse events 
• Situations that do not require reporting 
• Practical Activities via Vigilance Examples 
• MIR Form  FSCA, FSN, NCAR
• Vigilance Guide Documents For Specific Devices 

Benefits of the training 

• Ability to define PMS and Vigilance process changes under MDR
• Ability to identify the basic requirements of PMS and Vigilance processes according to MDR, MEDDEV 2.12-1 Rev8, Meddev 2.12.2 rev.2 and related  MDCG guides 
• Ability to outline the stages of PMS and the Vigilance process and documentation requirements 
• Ability to determine when vigilance reporting and trend reporting are required for a medical device 

References 
MDR, MDCG Guides, Meddev 2.12-1 Rev 8, Meddev 2.12-2 Rev 2