🇨🇿 PMS and PMCF activities: overview, planning, and documentation

The event is held in Czech language only!

The obligations of medical device manufacturers after placing a device on the market represent a comprehensive system of activities aimed at continuously verifying the safety and effectiveness of the device in real clinical practice. Key tools of this system include post-market surveillance (PMS) and post-market clinical follow-up (PMCF). The webinar will provide a comprehensive overview of the requirements of Regulation (EU) 2017/745 (MDR) in the area of PMS and PMCF and place them in the context of manufacturer's quality management system. Participants will clarify the basic terminology, links between individual processes, and their connection to clinical evaluation and risk management.

Within PMS, we will focus on an outline of possible activities, the structure of the PMS plan, reporting rules depending on the risk class of the device, including PSUR and trend reporting. For PMCF, we will focus on the objectives of this activity, practical implementation options, requirements for the content of the plan and report according to relevant MDCG documents, and its role as a source of clinical data for updating clinical evaluation. We will also briefly look at the area of vigilance. The aim of the webinar is to provide a practical and regulatory-compliant framework for setting up and documenting PMS and PMCF so that the system stands up to audit as well as in the manufacturer's everyday practice. 

Who the webinar is for:

• Regulatory specialists of manufacturers, importers, or distributors

• Employees of importers and distributors of medical devices in the positions of product manager and quality manager

• Sales representatives and marketing specialists

• Experts involved in the creation of technical documentation

• Persons responsible for regulatory compliance

• Anyone working in the medical device industry who wants to broaden their horizons in this area

Lecturers:

• Ing. Magdalena Folkmanová

• Mgr. Sidónia Molitorisová

Content:

• Structure and content of the PMS plan

• PMS report and Periodic Safety Update Report (PSUR)

• Continuity from QMS to PMS, risk management, and clinical evaluation

• Requirements for the content of the PMCF plan and report using MDCG 2020-7 and MDCG 2020-8

• Tips for compiling a PMCF questionnaire

• PMCF examination – brief overview of requirements and approval process

• Utilization of PMCF as a source of clinical data

• Shortcomings and how to prevent them in technical documentation

• Vigilance reporting

• Vigilance databases

  
  

Additional information:

• During the webinar, participants will have the opportunity to ask questions

• Each participant will receive a certificate of participation

• A PDF presentation will be sent to all participants

Participation fee:

• 3.900 CZK excluding VAT

• 100% cancellation fee applies after bindingly confirmed registration, but with the possibility of sending a replacement participant

Webinar hosted by:

• Porta Medica s.r.o.

• ID: 03301931, VAT: CZ03301931

• Registered office: Opletalova 1525/39, 110 00, Prague 1 - Nové Město