Medical Device Regulation: a lack of clarity and too much freedom of interpretation

As breakthrough innovations for wellness-related applications become increasingly ubiquitous, the path for the future regulation of innovation in Europe must be planned carefully, says Susana Solís.
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By Susana Solís

Susana Solís Pérez (ES, RE) is a rapporteur for the opinion of the Environment, Public Health and Food Safety (ENVI Committee) on the Artificial Intelligence Act

23 Jun 2021

The COVID-19 pandemic has shone a light on how we, EU citizens, look after our own health. For many of us, recent events have increased the need for us to take ownership of managing our wellbeing, as face-to-face interactions with healthcare providers were inevitably heavily disrupted.

Although self-care was already on the policy agenda before the crisis, its importance has been reinforced. This should help to ease some of the pressure on hospitals, which have traditionally been the key point of access to healthcare services and are currently overburdened.

In parallel, staying fit and active became a core focus for many of us, balanced against the enforced dramatic changes in our habits and restrictions on our lives over the past eighteen months. 

“The term ‘medical device’ covers a wide spectrum - from a replacement hip to the software monitoring your heart rate”

With various tools at our disposal, many citizens turned to innovative consumer technology, such as smart phones or smart watches. For many, these have emerged as essential devices for keeping track of our health, physical activity and mental wellbeing. This is in addition to more-specialised medical devices such as pacemakers or blood glucose monitors.

However, policymakers now face increasingly complex regulatory challenges. As these technologies become more ubiquitous, how do we ensure that we get the most out of the technology and protect innovation, while simultaneously ensuring that they are safe for people to use? 

For example, are smart phones and smart wearables general consumer electronics products or are they a personal medical device? How do we classify them? How correctly and according to its intended purposes? Also, what happens to the data generated by these devices? While some of these questions are the topic of debate, it is encouraging that - on the question of data - the European Commission has strongly stressed the need for dedicated data spaces that would allow for interoperable data registries and effective cross-border data flow.

In that sense, both the implementation of the Commission’s relevant European Data Spaces, as well as work on efficient and adaptable legal frameworks for new technologies and artificial intelligence, address the crucial issue of citizens’ safety and control over their data.

This feeds into the current, longstanding need to harmonise rules at European level. The new Medical Device Regulation (MDR), which was fully implemented in May, is now more important than ever, as it could help to address many of these questions. This piece of legislation could ensure appropriate access to safe and effective medical devices, whilst fostering innovation at national and EU levels.

However, it is worth highlighting that - as its implementation period has only just ended - questions will subsequently emerge that are currently not yet being considered. For example, it remains to be seen how the EU’s Member States have chosen to interpret certain aspects of the MDR.

We all agree on the need for effective regulation to protect public health. The question however, is under what circumstances the Regulation is best applied.

The term ‘medical device’ covers a wide spectrum - from a replacement hip to the software monitoring your heart rate. Taken to extremes, it could cover a vast number of technologies that support these devices, from cameras to heart sensors and the computers on which the software sits.

“Under-regulate, and we risk unsafe products entering the market. Over-regulate, and we reduce the incentives to find new applications for rapidly evolving technologies”

Consequently, how the Regulation applies to different devices that are, or may be classified as, medical devices could have critical implications for how technology develops and how quickly it can be applied to new medical uses.

Under-regulate, and we risk unsafe products entering the market. Over-regulate, and we reduce the incentives to find new applications for rapidly evolving technologies such as wearables and phones, and risk not harnessing those innovations that will help power the next wave of health technology.

This is not the first time that policymakers have faced such a dilemma, but resolving it as quickly as possible will be key to ensuring safe and secure access to those new technologies that will empower consumers and patients, as well as encouraging innovation in the eHealth industry.

The wider public health aim of empowering consumers to have greater control over their health in a safe manner should not conflict with the need for innovation in the eHealth industry. The MDR gives Europe a modern framework to ensure device safety, but much remains to be done.

With the rapid pace of progress in technology, we will continue to be faced with many questions on how we interpret and implement the Regulation. There is still a lack of clarity and too much freedom of interpretation. As we aim to protect the public health of all EU citizens, we must ensure that the new regulation will not slow down innovation.

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