Our experts can future-proof your vigilance system, post-market surveillance and safety reporting for devices and combination products.
Our vigilance experts can assist you with all the activities surrounding the notification and evaluation of adverse incidents and field safety corrective actions (FSCAs) involving medical devices and combination products; this includes Periodic Summary Reports (PSR) and trend reports as per MEDDEV 2.12-1, applicable in the EU and Switzerland.
Our experts support vigilance systems and post-market surveillance (PMS) for medical devices and post-marketing safety reporting (PMSR) for drug-device combination (DDC) products, either integral¹ or non-integral, through:
- Gap analysis and audit of PMS System
- PMS and PMSR SOPs definition, PMS plan and PMS system set-up
- Annual PMS report, PSURs and PMSR
- Advice on and analysis of the post-market clinical follow-up (PMCF) of any device and/or combination product
- ICSR management of combination products incl. fifteen- and five-day reports, malfunction reports and reports of deaths or serious injuries
- Meeting the challenging clinical reporting timelines, assisted by a pragmatic safety management plan
- Global or local scientific literature search
- Safety alerts screening from competent authorities websites
- Incidents & complaints management incl. FSCAs management (MDVS)
- Our ‘reality check’: adherence to FDA’s Medical Device Reporting requirements and to MD Coordination Group (MDCG) Guidance on vigilance and to device-specific vigilance guidance (DSVGs), as well as UK-specific DSVGs
- Use of eMDR, FAERS, Form 3331a for different types of combination products e.g., integral (not regulated by EU MDR 2017/745 Article 117) vs. co-packaged DDCs
- Advice on PV agreements with suppliers to ensure that they take into consideration additional data that need to be collected and communicated, such as device malfunctions and device-related events for combination products regulated as medicinal products.
¹ For integral DDCs regulated as a medicinal product, the device vigilance requirements of the MDR are not applicable but is recommended that the manufacturer has the technical knowledge and processes built into their Quality Management System (QMS) for handling, evaluating and investigating, where necessary, all device-related complaints.
clients have been supported
combination products in rare diseases