by Leeanne Baker, Managing Director and Quality & Regulatory Consultant at IMed Consultancy
Deadlines for the EU MDR implementation have been delayed once again, specifically to the end of 2027 for high-risk devices and to the end of 2028 for medium and certain lower risk devices. This delay provides an ideal window of opportunity for manufacturers to start developing a best-practice PMS strategy, especially since many requirements like PMS are already enforceable for all devices sold into the European Union.
Here are eight key steps to perfecting PMS:
- Keep up with deadlines and regulatory news
Deadlines for the EU MDR implementation have been delayed once again, specifically to the end of 2027 for high-risk devices and to the end of 2028 for medium and certain lower risk devices. Similarly, transition to full IVDR compliance has previously been rescheduled according to the classification of the device, with Class A and new devices requiring full compliance from May 2022, and a gradual deadline for devices already on the market that are Class D (May 2025), Class C (May 2026), Class B and Class A Sterile (May 2027). This delay provides an ideal window of opportunity for manufacturers to start developing a best-practice PMS strategy, especially since many requirements like PMS are already enforceable.
- Understand the key role of safety driving the new MDR
In particular, requirements relating to improving patient safety such as Post Market Surveillance (PMS), Periodic Safety Update Report (PSUR), Post-Market Clinical Follow up (PMCF) and the appointment of a Person Responsible for Regulatory Compliance (PRRC) are already in force.
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 patient safety. When potential issues are identified early on, it is possible to intervene in a number of ways to ensure that patients are not put at risk and can benefit from the positive outcomes they expected.
- Engaging with users and patients
This two-way conversation can help manufacturers assess any potential issues with their product that can only be identified through use. It may also serve the important role of uncovering off-label use of devices.
- Surveillance of published literature
Provides key evidence that can highlight risks or provide stronger proof of a product’s clinical benefit. Trade publications as well as broader nursing, medical or healthcare titles are also a good source of information.
- Monitoring social media channels
This helps keep the pulse of user and patient chatter but also ensure that marketing and communications departments are aligned with company compliance policy and not seeming to endorse off-label use of devices.
- Keeping up to date with competitor device performance
This is a key activity both as it is good commercial practice, but also because it also supports the ongoing assessment of ‘clinical benefit’ and ‘state of the art’ (SOTA), both of which are important new elements of the regulations.
- Reassess risk data for each device cyclically.
Best practice suggests that this activity should be carried out continually as new information comes to light, and irrespective of interim data, at least every year. Risk management data re-evaluation and update is performed to ensure that the device continues to maintain a suitable and acceptable risk profile, which may be impacted if expected complication rates have worsened because of a new issue. Proactive and frequent re-assessment of risk data will uncover these issues earlier, allowing safety issues to be more promptly addressed minimising or eliminating harm to patients, and the subsequent reputational and economic damage this can cause manufacturers.
- Embrace planning and evaluate team capacity
A rigorous, organised approach to PMS can lead to greater customer confidence, improved brand awareness, a reduction in complaints, and even administrative and compensation savings related to managing these issues – bringing manufacturers important commercial benefits.
Nevertheless, PMS is a cyclical process that requires significant man-hours and the support of highly specialised staff. Therefore, calling on the support of specialist consultants who are experts in satisfying post-market obligations should provide ample reassurance that manufacturers are meeting their obligations, are compliant and at the same time, ease the pressures from the growing regulatory onus on busy teams.
For more information download our free paper on PMS here.