Please login to the form below
Will most electronic consumer goods turn into medical devices after the MDR?
In her latest blog, Hanover Brussels Aleksandra Lugovic explores concerns over the rising coexistence of health apps and electronic goods that may become medical devices according to the EU Regulation.
Whilst waiting for more concise guidance from the European Commission, it is left to our own interpretation as to how far the Medical Device Regulation (MDR) will go when it comes to classifying general consumer electronics as medical devices.
The interaction between general consumer goods and medical software has been a revolutionary development for public health, given the vast number of medical applications that monitor the general public's health across a range of electronics. However, there is a rising concern among many manufacturers of consumer goods, not intended for medical purposes, that these devices could become classified as medical, simply because they allow and facilitate the work of third-party health apps.
The classification of common hardware sensors (microphone, camera, etc.) as medical device accessories, is a worrying prospect as it means that any phone, tablet, or watch could be considered a medical device accessory if facilitating the work of a health app, such as sleep monitoring, heart rate reader or other such available apps. This would eventually mean that these devices would have to undergo the same regulatory scrutiny and costly approval as devices with intended medical purposes, such as an ECG machine.
Under the MDR that kicked-off in May this year, a medical device accessory is required to undergo the same regulatory process as medical devices, which comes with considerable and costly compliance obligations to remain or enter the EU market. If this is to eventually include everyday electronics, we are likely to face a significant reduction in product diversity and innovation in the EU, as well as substantial price increases in the years to come. As consumer goods such as cars, computers and printers are increasingly making their hardware available to external apps, this could mean that our household devices could also become classified as medical devices.
The solution is simple. Rather than imposing further burdens to manufacturers and regulators when they are still recovering from a pandemic, the European Commission should stick to the basis of the MDR. All devices should be used for their intended purpose, meaning that devices with the intention to provide medical or health support to the public, including apps, should indeed be classified as medical devices under the MDR. However, devices with an original purpose not related to health or medical assistance should remain general consumer goods as they have been for many years.
Company Details
Hanover Communications
Address:
Riverside House
Southwark Bridge House
London
SE1 9HA
United Kingdom
Latest content on this profile
- Femtech: Transforming the future of women's healthcare
- Femtech is potentially the most important development in health care right now. Women's health has been under-researched and overlooked for successive generations - it's time that government and industry get ready to deliver.
Hanover Communications
- VPAS: The importance of making the right arguments, even in challenging times
- With key workers’ strikes, inflation, and immense pressure on public services, arguing for a more generous pricing settlement for the pharmaceuticals industry could not be tougher. Read our Health Director James Mole’s thoughts on the support needed to protect the UK life sciences’ ambitions, despite the challenging backdrop.
Hanover Communications
- Putting prevention at the heart of the future of the NHS
- Prioritising the prevention of cardiovascular disease (CVD) should be at the heart of plans to safeguard the long-term sustainability of the NHS. Unfortunately, action in this area has to date not matched ambition, putting thousands of patients’ lives – and the future of the health system – at risk.
Hanover Communications
- Action on Anti-microbial resistance: Will the UK rise to the challenge
- Timely and effective antimicrobials are the cornerstone of our healthcare systems, providing life-saving treatment and supporting vital services like routine operations, transplants and cancer treatment. We are three years into the UK Government’s 20-Year Vision for Antimicrobial Resistance (AMR), and the Department of Health and Social Care recently launched a consultation for the next iteration of the AMR National Action Plan (2024-2029). However, latest figures show that AMR is still on the rise. Is UK policy ambitious enough to drive innovation in AMR, and is the Government on track to contain, control and mitigate AMR by 2040?
Hanover Communications
- Winter and workforce woes: challenges facing the new Secretary of State for Health and Social Care
- For the third time this year, the NHS and social care has a new Secretary of State. The appointment must now signal stability following a period of political turbulence, as we head into what health leaders are describing as the toughest winter to date. Backlogs, delayed discharges, ambulance and A&E pressures, and crumbling NHS estates will remain top of Steve Barclay’s priority list in the coming weeks and months ahead. However, he will also need to address the longstanding workforce issues that hold back both the NHS and social care sector. Only dealing with these structural challenges will ensure the health and care system is operationally fit for winters to come.
Hanover Communications
- A new 10-year cancer plan: Will the government be able to deliver what the sector needs?
- The Truss Government has committed to developing a new 10-year cancer plan. But set against the backdrop of the Secretary of States priorities, what real value can the sector expect a new cancer plan to deliver? What questions need addressing to drive impactful change for patients? Will there be funding available to support the transformation? We will explore the state of play of cancer care in England and assess the main priorities, including how they align with wider NHS challenges. We will set out the difficult choices that a new plan must confront to enable prioritisation of this complex disease area and consider the balance between taking action to impact patients now versus initiatives to benefit patients of the future.
Hanover Communications
