Oh, MDR! Look, what have you done? Part 1
When we look at MDR for the first time, we could see it as a time demanding monster! A monster attacking innovations, overburdening administration and forcing companies to invest more resources into regulatory affairs. MedTech Europe had welcomed MDR with a warning and stated,” MedTech Europe welcomed the first wave of new EU medical device regulations last week but said there’s work that’s yet to be done.”
Well, when we inspect and investigate further, MDR is an opportunity!
There is a massive potential for innovation provided all processes are thoroughly prepared and followed by the organisations. Apart from the scope of innovation, MDR is a booster for expanding the Medical Device manufacturing industry as it has seen a 28% spike in new employees being hired. Putting the Pandemic and other factors aside, big companies have increased their capacities and introduced dedicated employees to ensure compliance and conformity with the new regulations.
MDR was rolled out with the aim of promoting strict regulations for the entire life-cycle of a medical device. The focus on General Safety and Performance Requirements covers diverse phases of the medical device life-cycle, which ensures complete protection for the patient receiving care. This regulatory overhaul scared many manufacturers as the additional requirements were seen as a barrier preventing innovation in the EU. The need for clinical studies is seen as a big hurdle for start-ups as it affects their financial strategies.
Indeed, the MDR imposes new and extended requirements, including documenting products’ clinical efficacy (clinical trials). But efficiently managed processes and Quality Management practices will reduce manufacturers’ burden by relieving them of product recalls.
Why do we consider MDR as a ‘Time Demanding’ Paper Monster?
The Medical Device Regulation EU 2017/745, adopted in 2017, aims to be modern, take up innovations, and reflect the current development in the field of eHealth - it contains points that better regulate medical devices that have software or Software As a Medical Device. For example, companies need to test and understand the capabilities and limitations of the platforms they work on. This includes variables such as contrast and size of screens. Minimum hardware and IT security requirements, including protection against unauthorised access, are now set by the manufacturer. Implementing these requirements can help improve public opinion on transparency and patient safety in the medical device industry.
Moving from the technology and software, the principles of MDR demand a lot of insights. Since the manufacturers need to dig deeper to collect insights on the product and its application reality, small manufacturers are scared because the intended purpose, and the actual outcome might have different meanings; for example, an App created as a wellness application might be a borderline medical device!
And even after obtaining the CE mark, the MDR provides several specifications/tools that manufacturers often view negatively because they are associated with time and financial expenditure.
Yet they offer opportunities to improve products. These are mainly increasing requirements for:
Risk management; and
General safety and performance requirements.
Is it a monster? Or isn’t it?
Well, at first, you may think it is a significant burden, but our experts see it as an opportunity for innovation and enhancement of patient care.
Let’s read this in Detail!
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