Regulatory
also help uncover the off-label usage of devices. Manufacturers need to be fully aware of any off-label use to ensure they are in no way complicit with it, which also means ensuring that, if a manufacturer becomes aware of off-label use, steps are taken to ensure that marketing and sales are never promoting or inferring that it is intended – even if it has become standard practice. Manufacturers are in fact duty- bound to inform users if they discover off-label use of a device, and take actions to contrast it. This is a scenario that could, for example, involve Health Care Professionals (HCPs) requiring training and education on the intended use of the device. Discovering an off- label use need not always be negative; in fact, it may offer interesting insight that enables the manufacturer to make new claims on their device, provided they gather enough clinical, safety and performance data to enable conformity assessment and approval.
Surveillance of published literature Medical device manufacturers cannot miss regularly analysing literature that is relevant to their product, or to similar products, as this provides a source of knowledge on their use, performance and safety. This literature provides key clinical evidence that may highlight potential risks, or even provide stronger proof of a product’s clinical benefit. Relevant trade publications that cover the market of application of the device, as well as broader nursing, medical or healthcare titles are also a good source of intelligence as they offer “on the field” views by practitioners, and even patients, as well as insights on broader issues relating to off-label use or common interactions with other devices or drugs.
Monitoring social media channels This activity is key to providing information directly from patients and users who recount their real-life experiences over social media. Social media monitoring also plays a key role in ensuring that marketing and communications departments are aligned with company compliance and messaging, such as not endorsing off-label use of devices. A superficial “We’re happy for you,” could easily be construed as support for off-label use and result in legal as well as reputational damage, if written in the wrong context.
Keeping up to date with competitor device performance
This is not only good commercial practice, but it also supports the ongoing assessment of ‘clinical benefit’ and ‘state of the art’, both of which are important new elements of the regulations. Checking competitor performance provides new data for ongoing clinical evaluation and can help demonstrate compliance with the new regulations. Should complaints or potential
Medical Device Developments /
www.nsmedicaldevices.com
issues be discovered with a device that is similar, or performing the same function, a window of opportunity opens in which to rectify any issue before it landslides and presents a risk to patient safety. Alternatively, it may provide the stimulus to ensure that there are objective differences between their own and competitors’ devices.
“Starting an ongoing two-way conversation with users of medical devices and patients will help manufacturers assess any potential issues with their product that can only be identified through everyday use.”
Reassessing the risk data for each device cyclically Far too many manufacturers prepare the risk management documents for the launch of their products accurately, but then fail to keep updating them with new statistics and data over time. Ideally, this activity should be carried out regularly, as new information comes to light from real-life use. Irrespective of interim data, best practice suggests that it should be carried out at least every year. Let’s say, for example, that if devices fail rates have worsened because an issue has been uncovered, the product’s entire risk profile should be reassessed to evaluate whether it remains acceptable or not.
In addition to being a requirement that brings many additional commercial benefits, PMS is a key step in the process of building compliance towards the MDR. In fact, manufacturers that maintain devices on the market under the transitional provisions are unable to make any significant changes in design or intended purpose of that device (MDR Article 120(3)) – severely limiting their competitive advantage. The surveillance requirements discussed in this article are in fact conditional to maintaining the device on the market under those transitional provisions (MDR Article 120) and existing certificates may only remain valid provided that the required surveillance is also completed by the NB that issued the certificate. 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. While it is essential that these truly extensive and complete monitoring activities are carried out routinely and consistently, a series of postponements have made space for businesses to perfect their compliance processes by establishing solid systems and processes to protect their devices from potential non-conformities and safeguard user and patient safety. ●
17
Alexander Supertramp/
Shutterstock.com
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20 |
Page 21 |
Page 22 |
Page 23 |
Page 24 |
Page 25 |
Page 26 |
Page 27 |
Page 28 |
Page 29 |
Page 30 |
Page 31 |
Page 32 |
Page 33 |
Page 34 |
Page 35 |
Page 36 |
Page 37 |
Page 38 |
Page 39 |
Page 40 |
Page 41 |
Page 42 |
Page 43 |
Page 44 |
Page 45 |
Page 46 |
Page 47 |
Page 48 |
Page 49 |
Page 50 |
Page 51 |
Page 52 |
Page 53 |
Page 54 |
Page 55 |
Page 56 |
Page 57 |
Page 58 |
Page 59 |
Page 60 |
Page 61 |
Page 62 |
Page 63 |
Page 64 |
Page 65 |
Page 66 |
Page 67 |
Page 68 |
Page 69 |
Page 70 |
Page 71 |
Page 72 |
Page 73 |
Page 74 |
Page 75 |
Page 76 |
Page 77 |
Page 78 |
Page 79 |
Page 80 |
Page 81 |
Page 82 |
Page 83 |
Page 84 |
Page 85 |
Page 86 |
Page 87 |
Page 88 |
Page 89 |
Page 90 |
Page 91 |
Page 92 |
Page 93 |
Page 94 |
Page 95 |
Page 96 |
Page 97 |
Page 98 |
Page 99 |
Page 100 |
Page 101 |
Page 102 |
Page 103 |
Page 104 |
Page 105 |
Page 106 |
Page 107 |
Page 108 |
Page 109 |
Page 110 |
Page 111 |
Page 112 |
Page 113 |
Page 114 |
Page 115 |
Page 116 |
Page 117 |
Page 118 |
Page 119 |
Page 120 |
Page 121 |
Page 122 |
Page 123 |
Page 124 |
Page 125 |
Page 126 |
Page 127 |
Page 128 |
Page 129 |
Page 130 |
Page 131 |
Page 132 |
Page 133 |
Page 134 |
Page 135 |
Page 136 |
Page 137 |
Page 138 |
Page 139 |
Page 140
