Lobbying on Implementing regulation for electronic instructions for use for medical devices

Implementing regulation for electronic instructions for use for medical devices

Public health

The new implementing regulation will allow to issue electronic instructions for use for all medical devices intended for exclusive use by healthcare professionals.

Links

Public consultation

ID: 14470

Lobbying Activity

17 responses

Consultation response

MedTech Europe, 20 Mar 2025

MedTech Europe warmly welcomes the European Commissions proposal for the update of the EU Regulation 2021/2226 laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards electronic instructions for use of medical devices. This is a…

Consultation response

European Patients' Forum (EPF), 20 Mar 2025

The European Patients Forum (EPF) generally supports allowing instructions for use in electronic format for medical devices intended for exclusive use by healthcare professionals in the legislation, however only in combination with the use of paper-based versions to ensure uninterrupted access to…

Consultation response

Association of the European Self-Care Industry, 21 Mar 2025

The Association of the European Self-Care Industry (AESGP) representing manufacturers of self-care medical devices welcomes the European Commissions proposal for the update of the EU Regulation 2021/2226 laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament…

Consultation response

Standing Committee of European Doctors, 20 Mar 2025

CPME Statement on medical devices electronic instructions for use.

Consultation response

The European Association of Hospital Pharmacists, 20 Mar 2025

The European Association of Hospital Pharmacists (EAHP) welcomes the proposed implementing act to increase the use of electronic instructions for use (eIFU), especially through its limitation to medical devices and their accessories intended only for professional use. However, EAHP would like to…

Consultation response

TÜV-Verband e. V., 20 Mar 2025

Der TÜV-Verband und die IG-NB begrüßen die öffentliche Konsultation der Europäischen Kommission zur Erweiterung des Anwendungsbereichs elektronischer Gebrauchsanweisungen (eIFU) für Medizinprodukte sowie die vorgeschlagenen Regelungen. Es ist wichtig, dass bei einer Ausweitung auch weiterhin die…

Consultation response

SPECTARIS Deutscher Industrieverband für Optik, Photonik, Analysen- und Medizintechnik e.V., 21 Mar 2025

SPECTARIS strongly supports the European Commissions initiative to update EU regulation 2021/2226. This proposal is a significant advancement as electronic Instructions for Use (eIFU) will enhance accessibility, searchability, and flexibility for medical device professionals and stronly supports…

Consultation response

Confindustria Dispositivi Medici, 20 Mar 2025

Confindustria Dispositivi Medici acknowledges the effort and this specific initiative put in place by the European Commission on the matter of electronic instruction for use for medical devices. Indeed, we are favorable to the update of the Regulation (EU) 2021/2226 proposed by the European…

Consultation response

European Hospital and Healthcare Federation, 21 Mar 2025

In a pure and perfect world, electronic product information provides easier and quicker information. However, situations like backouts, in particular with cyberattacks, needs paper instructions to be kept. The burden would be then passed to hospitals to print in advance the electronic product…

Consultation response

European Society of Radiology, 20 Mar 2025

The European Society of Radiology welcomes these proposed amendments to the existing regulations. Providing Electronic Instructions for Use (eIFU) to professional users improves overall accessibility, and removes the need to store and access physical copies in hospital departments, with all the…

Consultation response

European Council of Optometry and Optics, 21 Mar 2025

The European Council of Optometry and Optics (ECOO) welcomes the opportunity to provide comments on the draft Implementing Regulation aimed at expanding the scope of electronic instructions for use (eIFU) for medical devices. In 2024 opticians and optometrists throughout Europe responded to the EU…

Consultation response

MedicalMountains GmbH, 21 Mar 2025

MedicalMountains fully supports the European Commissions initiative to amend EU Regulation 2021/2226 and welcomes the possibility to comment on the draft implementing regulation within this consultation process. The initiative marks a significant step forward, as the broad use of electronic…

Consultation response

European Federation of High-tech Industries, 21 Mar 2025

Eurom welcomes the European Commissions initiative to revise EU regulation 2021/2226. Electronic Instructions for Use (eIFU) will improve accessibility, searchability, and flexibility for medical device professionals. It also strongly aligns with goals related to sustainability, resource and…

Consultation response

KCI Medical Belgium BV, 21 Mar 2025

About Solventum Solventum (registered in the transparency as KCI Medical Belgium BV) is a global healthcare company originating from the spin-off of 3M's healthcare business in 2024. The company employs over 22,000 people globally and has an annual revenue of $8.3 billion in sales in 2024. The…

Consultation response

EUROMCONTACT, 21 Mar 2025

EuromContact welcomes the draft Implementing Regulation aimed at expanding the scope of electronic instructions for use (eIFU) for medical devices. However, we regret that the revision remains limited to medical devices intended exclusively for healthcare professionals and remains to exclude: - the…

Consultation response

Bundesverband Medizintechnologie, 20 Mar 2025

Der Bundesverband Medizintechnologie e.V. (BVMed) begrüßt die vorgeschlagene Initiative der EU-Kommission zur Erweiterung des Anwendungsbereichs für elektronische Gebrauchsanweisungen für Medizinprodukte. Damit greift die EU-Kommission eine Forderung auf, die seit längerem von Industrieverbänden…

Consultation response

British Dental Industry Association, 20 Mar 2025

The British Dental Industry Association (BDIA) supports the proposed expansion of the provision of electronic Instructions for Use (eIFU) under the Medical Devices Regulation (EU MDR). The current provision for eIFU under the EU MDR is unnecessarily restrictive, and the proposed Implementing…