How to Navigate the Latest EU Medical Device Regulatory Landscape to Successfully Adapt your Pharma Portfolio
Understanding medical device regulations is essential for pharma- covigilance professionals seeking to master device vigilance compliance and operational excellence. This article delves into the essentials necessary to navigate the complex EU device vigilance regulatory landscape and considers differences in drug and device surveillance requirements to help pharma partners confidently adapt departments to the changes.
It discusses the practical challenges of integrating medical devices into pharmacovigilance portfolios, the obligations of device manufacturers, how to navigate the European Medical Device Regulation, maintaining effective post-market surveillance and managing the life cycle of a medical device.
Implementing Medical Devices in Pharmacovigilance Portfolios
When addressing the practical challenges of implementing medical devices in pharma- covigilance portfolios, it is important to bear in mind the components that are specific for devices or covered geographies, including definitions. These include:
- all device risks well understood by the pharmacovigilance department
- specific risk management documentation for each device to understand reportable events in advance
- a procedure for contacting the Quality Assurance (QA) department of the manufacturer for clarification
Appropriate regulatory information, such as device class, signal reference number (SRN) and regulatory agency details should be readily available. This might sound trivial, but it is a common cause of unnecessary errors. A good way to solve this problem is to cite a device in a database and have all these attributes that do not change. It is also helpful to have any previous field safety corrective action documentation in hand.
It is not possible to have one template and use it for everything because every device is different and has specific risks.
Obligations and Responsibilities in the Device Sector
The general obligations of device manu- facturers include implementing and keeping up-to-date a post-market surveillance system, maintaining a quality management system (QMS), and having a system for recording and reporting incidents and field safety corrective actions. The vigilance obligations are the manufacturers. A mandate must be in place which includes a responsibility to immediately inform the manufacturer about complaints and reports of suspected incidents.
Another key difference between drugs and devices concerns the obligations of economic operators in the device sector. In drugs, we have the marketing authorisation holder (MAH). In devices, we have got the manufacturer. If the manufacturer is not established in the EU, they must designate an authorised representative (AR). Pharmacovigilance departments may also be working closely with distributors as they should collect complaints and incidents and forward them to the manufacturer.
The Qualified Person for Pharmacovigilance (QPPV) is responsible for establishing and maintaining the pharmaceutical company’s pharmacovigilance system, having an overview of the safety profiles and emerging safety concerns for the company’s drugs, acting as a single contact point for Health Authorities on a 24-hour basis, monitoring product safety and risk-benefit balance, and ensuring the quality of the pharmacovigilance system. Device manufacturers must designate a Person Responsible for Regulatory Compliance (PRRC). While the roles are somewhat similar, the obligations differ and there should be close communication between them.
PRRC’s responsibilities, as set out in EU MDR (34), (35) and Article 15, include the QMS, regulatory documentation, post- market surveillance and vigilance reporting, and devices used for clinical investigation.
