Post-Market Surveillance (PMS) Compliance for Medical Devices
Ensure ongoing compliance with EU MDR and IVDR post-market surveillance requirements for medical devices and IVDs.
Post-Market Surveillance Requirements under EU MDR & IVDR
The EU Medical Device Regulation (EU MDR) and In Vitro Diagnostic Regulation (IVDR) ushered in a new era of post-market surveillance (PMS) requirements for medical device and IVD manufacturers. Device and IVD companies now face substantial post-market obligations that include consistent reporting, ongoing (clinical) data collection, and–depending on your product’s risk classification and/or conclusions from the clinical evaluation performed – Post-Market clinical investigations as part of Post-Market Clinical Follow-up (PMCF).
The MDR and IVDR are not explicit as to how far you must go to fulfill your PMS obligations. There is no formula and no checklist. Rather, the burden falls to the manufacturer to prove your device or IVD is safe, effective, and that its benefit-risk ratio remains acceptable throughout its lifecycle. Without a clear roadmap, device companies of all sizes struggle to implement and optimize an effective PMS system.
Our PMS Compliance Consulting services are designed to help manufacturers navigate the gray areas of EU MDR and EU IVDR. We’ll help you develop and implement a PMS system that meets all post-market requirements as they apply to your device so you can efficiently monitor your product’s safety and efficacy. Given that PMS activities will encompass all markets where your product is available, the PMS consulting service provided will be customized to meet your needs.
Integrate an Effective PMS System into ISO 13485 QMS
To achieve EU MDR and EU IVDR compliance, it’s crucial to integrate a robust PMS system into your existing Quality Management System (QMS), typically following ISO 13485. Our expert consultants will guide you through this process, ensuring that your PMS system seamlessly aligns with your QMS, creating a unified, efficient, and compliant structure aligned with your regulatory strategy for market entry.
Gap analysis
We identify any disparities between your existing QMS and the requirements for PMS integration, providing a clear roadmap for adjustments.
Integration strategy
We develop a tailor-made strategy for weaving PMS seamlessly into your QMS, ensuring minimal disruption to your existing operations.
Documented procedures
We assist in creating and documenting procedures that ensure ongoing PMS compliance within the ISO 13485 framework.
Develop and Incorporate an Effective PMS System into ISO 13485 QMS
A key part of post-market surveillance (PMS) under the EU MDR and IVDR is the creation and maintenance of essential documents. These documents are vital for demonstrating ongoing compliance and product safety.
Key PMS Documents We Help Develop:
- PMS Plan
- PMS Report or Periodic Safety Update Report (PSUR)
- Post-Market Clinical Follow-up (PMCF) or Post-Market Performance Follow-up (PMPF) Plan and Report
We offer PMS reporting templates available with or without consulting support. Our experts are experienced in the regulatory requirements and can guide you in developing these documents.
Ongoing Compliance for All Manufacturers
Compliance with EU MDR and EU IVDR PMS requirements is a continuous process that affects companies of all sizes, including small and medium-sized enterprises. Our consulting services are tailored to cater to the unique needs and constraints, ensuring that they can meet the same rigorous standards as larger manufacturers. Whether you’re a large corporation or start-up, we’re here to assist you in navigating the path to compliance, ensuring patient safety and product efficacy.
