Post-Market Surveillance (PMS) and Post-Market Performance Follow up (PMPF)
The IVDR sets out that ‘the clinical evidence and its assessment in the performance evaluation report shall be updated throughout the life cycle of the device.’ So, to fulfil post-market requirements, you’ll need to conduct a Post-market Performance Follow-up (PMPF).
The PMPF is meant to be a continuous collection of clinical data on the performance of your device after it has been placed on the market.
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Post-market information, such as data from the manufacturer’s post-market surveillance system should be reviewed regularly and used to determine the potential impact on the risks, clinical benefit and whether there is a need to update the performance evaluation report of the IVD.
As a manufacturer, you must ensure that all appropriate methods, procedures and product-specific triggers to proactively collect and evaluate safety, performance and scientific data are included as part of your PMPF plan.
Our team can support you with:
- Developing comprehensive PMPF strategies and plans
- Identifying relevant data sources, establishing data collection protocols and implementing systems for timely data analysis and reporting
- Updating PEP or PER as part of the PMPF
- Updating IVD clinical evidence, as appropriate
- Post-market performance studies
- Establishing procedures for signal detection, investigation and risk management, including the implementation of corrective and preventive actions (CAPAs) as necessary
Featured case studies
Software as a medical device (SaMD)
Software as a medical device (SaMD) Introduction Our client designs and sells a CE marked Class IIa software, used in cardiology as a digital twin. Types Regulatory affairs Responsible person FSP Scope of work Our client recently partnered with groups of clinics in the United Kingdom and therefore asked us to act as their UK…
QMS Implementation for Class III Medical Device
QMS Implementation for Class III Medical Device Introduction Streamlining ISO 13485 Certification for a connected medical device. The company is a highly innovative start up, which has developed a best-in-class pacemaker. At the time of engaging with them they were on the road to CE Marking. Apotech Team Worked full time on the project: balanced…
Borderline device classification
Borderline device Classification Introduction Classification of borderline product (cosmetics VS medical device) Our client, a multinational cosmetics and wellness product manufacturer identified revenue opportunities marketing their cosmetics devices with increase claims. Apotech was engaged to perform a blanket regulatory assessment of cosmetic devices and provide judgement and pathways for market authorisation as a medical device…
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