Post-market Surveillance (PMS), in the context of Quality Management Systems (QMS), refers to the systematic approach to collecting, recording, and analyzing data on the quality, performance, and safety of a medical device throughout its entire lifecycle, actively and continuously. This process is an integral part of a manufacturer’s QMS. It is essential for ensuring that a medical device continues to meet its intended purpose and remains compliant with the Essential Principles of Safety and Performance.

The medical device industry landscape is ever-changing owing to globalization and the advent of newer technologies. Due to these constant changes and developments, medical device organizations need robust change management systems.

A change can be prompted at various stages of the medical device life cycle. Some of the common events that can act as ‘triggers for changes include the following:

The MDCG (Medical Device Coordination Group) has released a position paper on UDI assignment to assist the manufacturers of spectacle lenses and ready readers about the obligations under the EU Medical Device Regulations (EU MDR) 2017/745. It also has the details to be considered while assigning an UDI (Unique Device Identification) to these devices. In addition, this position paper defines the data elements for BASIC UDI and UDI-DI groupings for spectacle lenses and ready readers.

You may know that the Medical Device Coordination Group (MDCG) has released a Q&A document related to previously released guideline - MDCG 2020-4: guidance on temporary and extraordinary measures related to medical device Notified Body audits during COVID-19 quarantine orders and travel restrictions. The recent release throws further light on key considerations while adopting remote audit model by the Notified Bodies for conformity assessments.

With the continual rise of COVID-19 cases, the healthcare facilities are witnessing shortage of respirators. Assessing the critical shortage and enormous demand for respirators, the global Regulatory agencies are swiftly initiating significant efforts to develop practical methods for decontaminating used respirators effectively. Accordingly, Singapore’s Health Sciences Authority (HSA) has issued guidance on facilitating access to safe and effective medical devices, intended for decontaminating used respirators through provisional authorization pathway.

Did you know? The US Food and Drug Administration (FDA) has set yet another high record by approving 106 novel devices in 2018, making it the most successful year for medical devices. With this accomplishment, FDA has surpassed its 40-year old record set in 2017 of approving 99 novel devices, showing a continuous growth for the past 8 years.

On April 5, 2017, the European Commission has approved the new Medical Device Regulations (MDR) - 2017/745-MDR and 2017/746-IVDR, which have come to effect in force (EIF) from May 25, 2017.