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New rules could add burden to medtech community

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New EU regulations coming into effect next year will require stronger control over medical devices and add costs.

A three-year transition period from Medical Devices Directive (MDD) to the new European Medical Device Regulation (MDR) was due to end in May 2020 but was postponed due to the coronavirus pandemic.

It is now coming into full effect on 26 May 2021 when the EU MDR’s implementation will require providers within the med-tech sector to ensure full compliance with each of its provisions, particularly the need to maintain an inventory of all medical devices.

The MDD, which was introduced in 1993 provides broad governance for medical devices in the EU plus Iceland, Liechtenstein, Norway, Switzerland, and Turkey.

It has been the core regulatory framework governing medical devices, defining what constitutes a medical device, setting out standards relating to the conformity mark those devices had to bear, requiring medical devices were proven to be working and that the benefits of their operation outweighed any possible negatives.

The MDR expands on that framework, imposing more demanding requirements on manufacturers to prove that their devices work as intended and that they have a system in place for surveillance to guarantee their product’s ongoing efficiency.

The new framework imposes more onerous requirements on the 500,000 types of medical and in vitro diagnostic devices on the worldwide market too, including instituting heightened pre-market risk assessments and reinforcing a European-wide coordination mechanism for clinical investigation of high-risk devices.

The MDR will also require that all medical devices have a unique device identification (UDI) code, which will be entered into the Eudamed database to ensure each is fully traceable, globally, back to their point of origin. This will add another layer of cost for those needing to implement the solutions.

Ana Maria Gimenez, global partners director at Sigfox, a French-based international provider of the internet of things, IoT, said: “While the medical device industry may be used to dealing with regulations, the updated version of MDR calls for stronger controls over device surveillance.

It places an increased burden on vendors and healthcare institutions to prove that the devices they utilise for patient care are safe and that each is logged in a centralised database.’’

She urged the adoption of IoT solutions, arguing that for European healthcare systems, where there are a number of medical devices in active deployment, IoT can simplify inventory-gathering and monitoring processes, and make it easier to achieve MDR compliance requirements.

By ensuring that each device is connected to a network, keeping track of the devices in service can be carried out more efficiently.

The Internet of Medical Things (IoMT) is expected to grow to £409bn within the next decade. The integration of the internet of things (IoT) into the healthcare environment is accelerating, as the coronavirus pandemic has increased demand for the roll out contactless solutions to minimise direct exposure between healthcare workers and patients.

She added: “Rather than viewing the updated MDR as yet another piece of regulation to deal with, administrators should consider its requirements as providing a perfect opportunity to implement better internal device tracking and data management systems.

“Given that the current pandemic itself has created a strong incentive for administrators to roll out IoT use in their healthcare systems, MDR could be regarded as a positive catalyst for growth, encouraging those that have not yet considered or adopted IoT to do so.

“In addition to assisting with compliance efforts, connecting medical devices to monitoring systems through IoT networks can help administrators gain great insights into device utilisation.’’

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