Medical implant with data stream, symbolizing transparency.

Medical Device Safety in Europe: Doctors Demand Transparency

Jordan Keane in Health & Wellness November 2025 • 4 min read.

"Amidst rising concerns over device malfunctions, European doctors and consumer groups unite to push for public access to safety evidence."

The safety of medical devices has become a focal point of concern across Europe. Recent investigations have revealed a rising number of malfunctions and injuries associated with these devices, prompting calls for greater transparency from manufacturers and regulatory bodies. The push for open access to safety data is gaining momentum, with senior doctors, consumer groups, and transparency advocates urging the European Commission to take decisive action.

At the heart of the debate is the balance between protecting manufacturers' commercial interests and ensuring patient safety. The European Commission is under pressure to mandate the public disclosure of all evidence related to the safety of high-risk medical devices. This move aims to empower healthcare professionals and patients with the information they need to make informed decisions.

The current regulatory landscape is on the cusp of change, with a new EU law set to take effect in 2020. While this law aims to enhance data transparency, concerns remain about the extent to which detailed information will be accessible to the public. The outcome of this debate could significantly impact the future of medical device regulation and patient safety in Europe.

Why Doctors Are Calling for Open Access to Medical Device Data

Medical implant with data stream, symbolizing transparency.

Medical professionals are increasingly concerned about the lack of transparency surrounding the safety of medical devices. Dr. Terence Stephenson, chair of the UK General Medical Council, emphasizes that unbiased and comprehensible data sets should be publicly available. This call is rooted in the belief that transparency is essential for improving patient outcomes and fostering trust in the healthcare system.

The benefits of open access to medical device data are multifaceted. Publicly available data on device malfunctions and injuries can significantly improve device safety by empowering patients and healthcare professionals. It also increases scrutiny on industry practices and regulators, promoting accountability and driving improvements in device design and testing.

Enhanced Patient Safety: Access to safety data enables informed decision-making by both doctors and patients.
Increased Accountability: Public scrutiny of device performance promotes manufacturer responsibility.
Improved Device Design: Insights from incident reports can drive innovation and enhance device safety.
Greater Public Trust: Transparency fosters confidence in the healthcare system.

International voices are echoing the call for greater transparency. Medical colleges in Spain assert that data should be public by default, accessible, and usable on the internet, with privacy restrictions applied only when necessary. Similarly, representatives from Sweden's Uppsala Monitoring Centre argue that medical devices should be subject to the same stringent regulatory principles as medicines, emphasizing that no regulatory process can be effective without transparency and open communication.

The Path Forward: Ensuring Transparency and Patient Safety

The demand for transparency in medical device regulation is a critical step toward ensuring patient safety and building trust in the healthcare system. As the European Commission prepares to announce its plans for data sharing, the voices of doctors, consumer groups, and transparency advocates must be heard. The future of medical device regulation hinges on the commitment to providing accessible, unbiased, and comprehensible information to all stakeholders.

About this Article -

This article was crafted using a human-AI hybrid and collaborative approach. AI assisted our team with initial drafting, research insights, identifying key questions, and image generation. Our human editors guided topic selection, defined the angle, structured the content, ensured factual accuracy and relevance, refined the tone, and conducted thorough editing to deliver helpful, high-quality information.See our About page for more information.

This article is based on research published under:

DOI-LINK: 10.1136/bmj.k5105, Alternate LINK

Title: Doctors Demand To See Evidence On Safety Of Medical Devices Approved In Europe

Subject: General Engineering

Journal: BMJ

Publisher: BMJ

Authors: Simon Bowers

Published: 2018-11-30

Everything You Need To Know

What specific information are European doctors demanding be made public regarding medical device safety?

The primary demand is for public access to comprehensive safety evidence related to medical devices. Doctors and consumer groups specifically want the European Commission to mandate the public disclosure of all evidence pertaining to the safety of high-risk medical devices. This push stems from concerns about device malfunctions and injuries, highlighted by investigations like the Implant Files, and aims to empower healthcare professionals and patients to make informed decisions.

How could open access to medical device data improve patient outcomes and the healthcare system?

Open access to data concerning medical device malfunctions and injuries is expected to enhance patient safety by enabling informed decision-making for both doctors and patients. Increased scrutiny promotes manufacturer accountability, potentially leading to improved device design through insights from incident reports. Enhanced transparency also fosters greater public trust in the healthcare system. Furthermore, applying stringent regulatory principles like those used for medicines could significantly elevate medical device safety standards.

What are the potential limitations of the new EU law taking effect in 2020 regarding medical device data transparency?

The new EU law taking effect in 2020 is intended to enhance data transparency, but concerns persist about the extent to which detailed information will be accessible to the public. Transparency advocates are pushing for comprehensive data availability, while manufacturers are concerned about protecting commercial interests. The balance struck by the European Commission will significantly impact the future of medical device regulation and patient safety in Europe.

Which international organizations or figures are supporting greater transparency in medical device regulation, and what are their specific arguments?

Dr. Terence Stephenson, chair of the UK General Medical Council, has emphasized the importance of making unbiased and comprehensible data sets publicly available. Medical colleges in Spain advocate for data to be public by default, accessible, and usable on the internet, with privacy restrictions applied only when necessary. Representatives from Sweden's Uppsala Monitoring Centre argue that medical devices should be subject to the same stringent regulatory principles as medicines. These international voices collectively support greater transparency in medical device regulation to enhance patient safety.

What are the potential implications of the current lack of transparency in medical device regulation on patient outcomes and industry practices?

The lack of transparency has implications for patient outcomes, industry practices, and regulatory accountability. Without access to comprehensive safety data, healthcare professionals and patients may not be fully informed when making decisions about medical devices. Increased transparency can improve device design and testing. Greater transparency and scrutiny can also promote more responsible behavior from manufacturers and regulators, fostering trust in the healthcare system.