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Electronic instructions for use for medical devices

Public health

To ensure the smooth implementation of the new regulatory framework for medical devices (Regulation (EU) 207/2012), economic operators are allowed to provide instructions for use in electronic format in place of paper format for certain categories of medical devices. The new implementing regulation expands the scope of the Regulation to include medical device software.

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Public consultation

ID: 12954

Lobbying Activity

11 responses

Consultation response

MedTech Europe, 25 May 2021

MedTech Europe is pleased to provide its comments via the enclosed document.

Consultation response

UNI Europa, 24 May 2021

On behalf of UNI Europa Graphical & Packaging: We are very concerned about the way in which the narrative promoting digital media has been introduced at all levels by identifying the use of paper with a higher environmental impact, without taking into account the contribution of forest-based…

Consultation response

European Coordination Committee of the Radiological, Electromedical and healthcare IT Industry, 25 May 2021

COCIR appreciates the additional opportunity to provide industry feedback to the draft Implementing Regulation on electronic instructions for use (IfU) under the Medical Device Regulation. In general, the availability of electronic IfU is wider than providing one hardcopy. Commonly used…

Consultation response

The European Association of Hospital Pharmacists, 25 May 2021

The European Association of Hospital Pharmacists (EAHP) welcomes the European Commission’s proposal for the Implementing Regulation 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…

Consultation response

TÜV-Verband e. V., 21 May 2021

Art. 5 (12) Gebrauchsanweisungen sollten nach Abschluss des Konformitätsbwertungsverfahrens grundsätzlich nicht geändert werden bzw. nur in Folge von “corrective actions”. Daher sollte "or" durch "caused by" ersetzt werden. "(12) effective systems and procedures shall be in place to ensure that…

Consultation response

European Industrial Gases Association AISBL, 17 May 2021

EIGA is a non-profit European Association representing the majority of medicinal gases and medical device gases manufacturers. Medical device gases, such as carbon dioxide and liquid nitrogen, are delivered in container closure systems such as high pressure gas cylinders and vacuum insulated…

Consultation response

SPECTARIS Deutscher Industrieverband für Optik, Photonik, Analysen- und Medizintechnik e.V., 25 May 2021

SPECTARIS is the German Industry Association for Optics, Photonics, Analytical and Medical Technology based in Berlin. The association represents 400 predominantly medium-sized German companies. This initiative aims to renew the existing eIFU rules established under Commission Regulation (EU)…

Consultation response

European Carton Makers Association, 24 May 2021

The feedback from the 'European Carton Makers Association' is contained in the attached document

Consultation response

MED-EL Elektromedizinische Geräte GmbH, 25 May 2021

We acknowledge the proposed update to Regulation 207/2012 relating to electronic instructions for use for medical devices, and recognize the value in the provision of such information in electronic form for medical professionals and users of MED-EL hearing implants / devices. In preparation for…

Consultation response

EUROMCONTACT, 25 May 2021

EUROMCONTACT is the association representing the contact lens and lens care products manufacturers in the European Union. We represent more than 90% of the soft contact lens and 80% of the contact lens care products, and more than 50% of the rigid contact lenses in the European market.…

Consultation response

Raúl Alberto Sousa, 24 May 2021

The package insert is the main source of information on medical devices, being consulted by both health professionals and users. It is in itself difficult to interpret for the general population due to the complexity of the vocabulary used, and it is also frequently associated with difficulty in…