IA-CLI-04 1 day (7h) · Virtual classroom

PMCF and PMCF — Designing and managing post-market clinical follow-up

CE marking is not a finish line. Since the entry into application of Regulation (EU) 2017/745, post-market clinical follow-up has been a continuous, documented and audited obligation. Yet many manufacturers still approach PMCF as a formality rather than as a fully-fledged clinical risk management process. This one-day training gives regulatory, clinical and quality affairs professionals the concrete keys to design a robust PMCF plan, choose the appropriate data collection activities and produce the deliverables expected by notified bodies — PMCF plan, PMCF evaluation report, contribution to the PSUR.

Audience Regulatory affairs (RA) managers and officers, clinical affairs project managers, quality managers involved in technical documentation and post-market follow-up of class IIa, IIb and III medical devices.

Learning objectives

  • ▸ Distinguish the requirements of PMCF (Annex XIV, Part B of MDR 2017/745) from those of PMS in the broad sense, and position PMCF within the technical documentation
  • ▸ Design a PMCF plan compliant with the MDCG 2020-7 templates, defining the objectives, indicators and collection methods appropriate to the device's risk profile
  • ▸ Select and justify the appropriate clinical follow-up activities (structured literature reviews, registries, user surveys, non-interventional observational studies) according to the class and intended purpose of the medical device
  • ▸ Draft or revise a PMCF evaluation report compliant with the MDCG 2020-8 template, articulating the results with the clinical evaluation report (CER) and risk management (ISO 14971)
  • ▸ Feed the PSUR (Periodic Safety Update Report) from PMCF data, complying with regulatory deadlines according to the device class
  • ▸ Identify common non-conformities raised during notified body audits on PMCF and implement appropriate corrective measures

Expected outcomes

  • ✓ An annotated PMCF plan applicable to your own device or range
  • ✓ A checklist of deliverables expected by notified bodies

Accessibility & entry conditions

Access lead time

Registration up to 10 working days before the start of an open-enrolment session. In-house sessions can be scheduled within 3 to 4 weeks.

Prerequisites

Basic knowledge of the MDR 2017/745 regulatory framework recommended. Practical experience in regulatory, clinical or quality affairs in the medical device sector facilitates immediate application of the content. No formal blocking prerequisite.

Disability access

Any disability situation can be accommodated. Contact our officer before registration to explore possible adjustments (equipment, materials, pacing). Contact our officer →

Funding

  • ·This training is not Qualiopi-certified and is not eligible for funding via the OPCOs
  • ·Funding through own funds or the company's training budget

Detailed programme

A phone interview or positioning questionnaire is sent ahead of the session to calibrate the level, identify expectations and tailor the case studies to participants' real situations.

  1. 01

    Regulatory framework and positioning of PMCF in the life cycle (1 h)

    • ·Articulation of PMS / PMCF / clinical evaluation under MDR 2017/745 (articles 10.10, 61, Annex XIV Part B)
    • ·Differences from the requirements of Directive 93/42/EEC
    • ·Role of PMCF in the continuous update of the CER and the PSUR
    • ·Points of vigilance raised by notified bodies during renewal audits
  2. 02

    Designing the PMCF plan (2 h)

    • ·Structure of the PMCF plan according to the MDCG 2020-7 template: objectives, performance indicators, success and failure criteria
    • ·Selection of collection activities: structured literature review (MEDLINE, specialized databases), patient registries, satisfaction and misuse surveys, non-interventional PMCF studies
    • ·Proportionality to the risk and class of the device
    • ·Practical workshop: building an annotated PMCF plan on an anonymized case
  3. 03

    Conducting activities and collecting data (1 h 30)

    • ·Literature review protocol for PMCF
    • ·CRF (Case Report Form) and data to be collected within an observational study
    • ·Clinical data management: traceability, archiving, GDPR compliance
    • ·Long-term management: milestones, periodic review of the plan
  4. 04

    Drafting the PMCF evaluation report and feeding the PSUR (1 h 30)

    • ·Structure of the PMCF evaluation report according to the MDCG 2020-8 template
    • ·Link with the CER: updating the benefit/risk conclusions
    • ·Contribution to the PSUR (classes IIa, IIb, III) and to the PMS report (class I)
    • ·Exercise: identifying gaps in a fictitious PMCF report
  5. 05

    Common non-conformities and corrective actions (1 h)

    • ·Lessons learned from notified body observations concerning PMCF
    • ·Operational compliance checklist
    • ·Questions and answers and summary of the day

Assessment of learning

Assessment methods

20-question QCM at the end of the day covering regulatory requirements, the structure of deliverables and the practical cases addressed. The PMCF plan construction exercise (module 2) is the subject of a collective correction allowing assessment of the ability to apply the content.

Certificate

Training certificate issued by Isofac Group at the end of the training, subject to full participation in the session. This certificate does not constitute a certification recognized by the RNCP or the Specific Directory (RS).

Satisfaction and results

Satisfaction rate: Being measured

First learner survey campaign under way — data published once the statistical threshold is reached.

Training team

Training delivered by the ISOFAC ACADEMY teaching team, made up of consultants specialised in medical devices, quality and regulatory affairs. Depending on the module, the session is led by a specialist with hands-on operational expertise in MDR compliance, ISO 13485 quality management systems, ISO 14971 risk management, clinical evaluation, technical documentation, regulatory audits and CE marking strategy.

Our trainers support manufacturers, distributors, importers, authorised representatives and other economic operators on a daily basis in bringing their medical devices into compliance. See the team's profiles →

Technical resources

In-person

Room equipped at the client site or in a partner centre (Montpellier, Lyon, Paris). Video projector, flipchart, printed materials.

Remote

Zoom (corporate) platform for the virtual classroom. Materials provided in PDF + access to additional resources for 12 months after the session.

Learner equipment

A connected computer with camera and microphone for remote sessions. No software to install.

Post-course follow-up

Advice line

Hotline included for 30 days after the session for operational questions arising back on the job. Reply within 48 working hours.

Follow-up review

3-month review sent to the sponsor for in-house courses: feedback on the skills put into practice and any residual points.

Open-enrolment price (excl. VAT)

890 €

EU VAT applicable depending on the buyer's status.

In-house price

On request, depending on headcount and location.

Funding

  • ·This training is not Qualiopi-certified and is not eligible for funding via the OPCOs
  • ·Funding through own funds or the company's training budget

Personalised quote within 48 hours.

Would you like to attend this course?

Tell us your preferred format (open-enrolment, in-house or virtual classroom), the number of participants and your schedule. We will get back to you within 48 hours with the next available dates and a firm quote.

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