Join NAMSA for the Virtual RAPS Convergence 2020

Session Leader: Adrian Keene, BSc (Hons); Director EMEA, Consulting Services

The introduction of the EU MDR brings greatly increased ongoing Post-Market Surveillance (PMS) expectations for both manufacturers and economic operators. Articles 83-86 and Annex III detail the requirements, but without defining the expectations to be fully compliant. It is often difficult for manufacturers to translate their existing PMS data and processes into the more rigorous framework of the EU MDR. Creating a pragmatic process that fulfils requirements whilst not becoming overly burdensome is critical to the ongoing success of the PMS system.

This session will address the practical aspects of setting up an effective PMS plan, considering the requirements and methods tailored appropriately to class and nature of the device. Selecting sources of data to set and monitor suitable indicators and threshold values will be addressed, as well as effective trend reporting and monitoring. The output of the PMS process is the PSUR (article 86) or post-market surveillance report (Article 85), which supports the ongoing risk/benefit assessment, and becomes an integral part of continued compliance to the MDR. Information is drawn together from many sources, including risk management, post market clinical follow-up (PMCF), vigilance, trend reporting and clinical evaluation. To implement a practical process to prepare these documents the inter-relationship between the relevant processes needs to be understood. We will address the practical execution of the PSUR process, considering timelines to gather data from relevant sources, and providing a meaningful output for both manufacturers and regulators. Potential challenges and pitfalls will be considered.

Learning Objectives:

– Demonstrate their understanding of the key concepts and requirements of PMS and its outputs.

– Interpret the principles discussed and apply them practically within their organization to create pragmatic solutions to meet PMS/PSUR requirements.

– Review their organization’s current PMS processes to address this need and amend them to create pragmatic solutions to meet the requirements.

Session Speaker: Jane Arnold-Round; Principal Regulatory Consultant

Most medical device manufacturers have elected to renew their MDD/AIMD CE certificates early to take full advantage of the soft transition. By doing this manufacturers were able to delay when the technical documentation had to be updated. This strategic delay provides an opportunity to learn from the experience of others, however manufacturers must not wait to long. The required changes to the technical documentation to demonstrate compliance to the MDR is not a simple compilation or reformatting exercise. Manufacturers must plan adequate time and resources to ensure the technical documentation updates are compliant to the MDR and have a submission strategy that avoids the anticipated bottleneck of submissions leading up to 26 May 2024.

During this session the time and resources required to update technical documentation for low risk simple devices and high risk complex devices will be discussed. Speakers will describe to attendees the challenges and roadblocks that were encountered, and any lessons learned. A Notified Body reviewer will share experiences during the review of MDR technical documentation, share common non-compliant areas and discuss the anticipated best time to submit.

Learning Objectives:

– Create a strategy for the required start and completion of MDR technical documentation updates.

– Describe, anticipate and avoid potential challenges and non-compliance.