Have your say – Medical Devices

You can also get involved in forming EU laws. The European Commission offers a platform “Have your say” with the list of all new EU initiatives open for public consultation. You need to register to write your feedback: ec.europa.eu/info/law/better-regulation/have-your-say

Medical devices and in vitro diagnostics – targeted revision of EU rules

About this initiative: This initiative seeks to simplify EU rules for medical devices and in vitro diagnostics. It aims to ensure availability of safe and innovative devices to safeguard a high level of patient safety, public health and healthcare.
Feedback period: 
for stage 2 it is 08 September 2025 – 06 October 2025
for stage 5 it is 07 January 2026 – 16 March 2026
Link: https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/14808-Medical-devices-and-in-vitro-diagnostics-targeted-revision-of-EU-rules_en

Feedback from Europeans for Safe Connections for stage 2

Europeans for Safe Connections (ESC) fully concurs with the stated objective of Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR), which is “to establish a robust, transparent, predictable and sustainable regulatory framework for medical devices which ensures a high level of safety and health whilst supporting innovation”.

ESC places paramount importance on ensuring a high level of safety and health for all patients, with particular emphasis on individuals affected by electromagnetic hypersensitivity (EHS). We strongly believe that electromagnetic fields (EMFs) emitted by medical and hospital structures, as well as by medical devices, can constitute significant barriers to accessibility for EHS individuals. This concern underscores our commitment to patient safety and equitable access to healthcare. EHS is a condition where individuals experience adverse health effects from exposure to electric, magnetic, or electromagnetic fields, with symptoms often occurring at levels well below international safety guidelines. Hospital environments, with their multiple sources of EMFs, pose a considerable challenge for these patients.

In line with the Treaty on the Functioning of the European Union, specifically Article 168(4), point (c), a high level of human health protection must be ensured in the definition and implementation of all Union policies and activities. This includes adopting measures that set high standards of quality and safety for medicinal products and devices for medical use.

ESC has actively engaged in the consultation process. We previously submitted a comprehensive dossier, in December 2024 and again in March 2025, detailing our considerations and proposals regarding the health implications of artificial electromagnetic fields, our specific requests for technical specifications, and our perspective on the recognition of experts within the EU HTA joint activities. Furthermore, on December 21, 2024, we forwarded a proposal to Mr. Marco Marchetti, Co-Chair of the Medical Device Coordination Group (HTACG), suggesting amendments to the medical devices template to specifically address all wireless connections incorporated within these devices.

ESC has also affirmed its readiness to propose qualified, conflict-of-interest-free experts on the health hazards associated with electromagnetic fields to the HTA Stakeholder Network.

Feedback from Europeans for Safe Connections for stage 5

We, Europeans for Safe Connections (ESC), have the following comments to the document Evaluation and the Regulation :

The Evaluation document does not explicitly mention electromagnetic fields (EMF) or the condition of electromagnetic hypersensitivity (EHS). The Commission’s text focuses almost exclusively on:

• Administrative burdens and procedural complexity.
• Compliance costs that are disproportionate, particularly for SMEs.
• Device availability and the competitiveness of the sector.

ESC emphasizes that EMFs emitted by medical devices can create significant accessibility barriers for EHS individuals. We request an amendment of the medical device templates to include technical specifications for incorporated electromagnetic sources, such as Wi-Fi or Bluetooth.

ESC agrees with the objective of Regulation 2017/745 to ensure a high level of safety and health, but remarks that in the present proposed Regulation there is no specific reference to protecting human health from risks associated with artificial EMF.

We propose including, in device documentation, a list of technical specifications, including parameters related to Extremely Low Frequency (ELF), Low Frequency (LF), and Radio Frequency (RF) fields—such as power density, transmission duration, modulation technique, duty cycle, magnetic flux, field intensity, magnetic field type, and absorption rates—in accordance with Article 168(4) of the TFEU.

While the Evaluation document recognizes the need for “targeted adjustments” to align with technological development and market realities, its focus appears to be on simplifying rules to foster innovation rather than introducing new environmental or electromagnetic safety parameters.

Our request is also in line with Budapest Declaration by WHO where it is stated: “new and emerging issues, such as electromagnetic radiation, require attention and response“
iris.who.int/server/api/core/bitstreams/781a703d-e062-4eba-b11c-a224a7861abf/content

Experts Involvement and the Stakeholder Network: ESC is ready to propose qualified, conflict-of-interest-free experts regarding health hazards associated with electromagnetic fields.

Best regards
Europeans for Safe Connections
This feedback was sent from a wired internet connection
– No use of harmful radiation
– Less electricity consumption
– Increased data security

The link to our feedback: https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/14808-Medical-devices-and-in-vitro-diagnostics-targeted-revision-of-EU-rules/F33365221_en

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