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.
Trusted by top-tier teams worldwide
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
EU-MDR Technical File Authoring
EU-MDR Technical File Authoring Introduction Medical Technology Client Our client is a leader in high-quality, surgeon-designed, innovative ophthalmic products located in the US with operations globally. These range from Class I through to Class III devices. Apotech Consultants Our consultants take a risk-based approach to improve quality and compliance, and implement practical solutions for your…
A genetic testing kit manufacturer Journey to UKCA Marking with Apotech
Introduction The client In response to the UK’s new post-Brexit regulatory requirements, our client, an innovative genetic testing kit manufacturer, collaborated with Apotech to achieve UKCA marking. This strategic move was aimed at maintaining their market presence in the UK, ensuring uninterrupted access for their cutting-edge products. Types Scope of work Apotech provided end-to-end support…
510(k) Submission
510(k) Submission Introduction Radiographic Dental Imagery Device – Class IIb Our client are a leading manufacturer of radiographic dental imaging systems, based in Europe. Following European success, our client set their sights on the US market. Standards & Tools FDA 21 CFR Part 820 GDPR Word Excel, Powerpoint Scope of work Review of documentation for…