PMS and patient safety: shifting to a proactive approach
Despite deadlines for the EU MDR 2017/745 and the EU IVDR 2017/746 (IVDR) implementation being pushed back once more, certain aspects of the MDR that are closely linked to patient safety, such as the need for cyclical and proactive Post Market Surveillance (PMS), are already enforceable.
This clearly indicates a stronger focus shift to proactivity, with PMS and patient safety being cardinal elements of the MDR. The objective of carrying out extensive, ongoing monitoring is to ensure that device safety issues are identified early on, reducing or completely eliminating any impact on patients.
Proactivity is the key – especially when it comes to regulatory compliance
Although transition arrangements have been welcomed by the industry, manufacturers should avoid being lulled into a false sense of security by the ever-shifting deadlines. Not only is preparedness a key to ensure competitivity but as of 26th May 2021[i] manufacturers need to be compliant with PMS, PSUR (Periodic Safety Update report), PMCF (Post-Market Clinical Follow up) and PRRC (Person Responsible for Regulatory Compliance) requirements of the EU MDR.
In this blog IMed’s team will focus on patient safety and on how manufacturers can ensure their PMS truly satisfies regulatory requirements.
The importance of proactive PMS for patient safety
While PMS has always been intended to be preventive, under the MDR there is a stronger focus shift to proactivity with PMS being a cardinal element of the MDR.
Carrying out extensive, ongoing monitoring allows manufacturers to ensure that device safety issues are identified early on, reducing or completely eliminating any impact on patient safety. Furthermore, when potential issues are identified early on, it is possible to intervene pre-emptively to ensure that patients are not put at risk and can benefit from the positive outcomes they expect.
Beyond regulatory compliance: additional benefits of PMS
While patient safety is a key driver for the MDR, manufacturers can also reap a number of commercial benefits from adhering to a rigorous PMS system. Manufacturers that thoroughly canvass the market for data and act upon the intelligence it yields will benefit from:
- greater customer confidence
- improved brand awareness
- a reduction in complaints
- administrative and compensation savings (related to managing these complaints)
In addition, PMS is also a requirement for placing devices in other international markets, so efforts to comply with the MDR can also prove useful for export strategies.
Regulatory compliance – is outsourcing the best choice for you?
The onus of the activities covered by PMS should not be underestimated, however, and for this reason manufacturers would do well to devote this extra time to focus on perfecting their PMS strategy.
This and other ongoing processes typically require significant investments both in time and in highly specialised staff. Outsourcing to a team of specialist consultants who are experts in satisfying post-market obligations can ease pressure on internal teams, while ensuring compliance and the right proactive approach.
Find out how experienced regulatory and compliance consultants can help support you when it comes to PMS and other MDR requirements areas in IMed Consultancy’s latest whitepaper on PMS
Alternatively, reach out to us directly for tailored, specialist support that takes the pressure off your in-house teams and write to email@example.com
[i] European Commission, Press Corner, Questions and Answers: Commission proposes an extension of the transitional periods for the application of the Medical Devices Regulation