Study supporting the monitoring of availability of medical devices on the EU market

Surveys for MD and IVD manufacturers, authorised representatives, importers and distributors

The European Commission’s Directorate-General for Health and Food Safety (DG SANTE) - via its European Health and Digital Executive Agency (HaDEA) - commissioned a “Study supporting the monitoring of the availability of medical devices on the EU market” to a consortium led by the Austrian National Public Health Institute (Gesundheit Österreich GmbH / GÖG), in collaboration with Areté and Civic Consulting.

The general objective of the study, which started in December 2022 and will last 36 months, is to support the monitoring of the availability of medical devices on the EU market in the context of the implementation of regulations* on medical devices and in vitro diagnostic medical devices from the perspectives of key stakeholders. Large stakeholder consultations are conducted in the context of this study.

To be able to monitor the availability of medical devices (incl. in vitro diagnostics) on the European market, it is vital to obtain information from manufacturers (MF) of medical device and in vitro diagnostics as well as from authorised representatives (AR), importers (IM) and distributors (DB). We kindly ask all economic operators, including those who plan to place MDR and IVDR compliant devices on the market in the next two years, to respond to the survey.

Note: This is already the second survey round with economic operators in this study. The first survey round took place from November 2023 to January 2024. The question set in this survey is very similar to the question set in the first survey round to allow for comparability of the results to some extent. The study team is aware that between the first and this second survey round the deadlines for transitioning medical devices from the relevant directives to the new regulations came into effect, which had an impact on the rephrasing of some of the questions. The questions were developed in collaboration with the MDCG Task Force (TF) on certification capacity monitoring and industry representatives. The European Commission is currently conducting a targeted evaluation of the MDR and IVDR. In this context, specific questions aiming at informing the targeted evaluation were integrated in this survey. These questions are also aimed at importers and distributors.

The results of the first survey round have been compiled and analysed by the study team and are now published: Link to the dashboard and presentation.

We will keep any company-specific information (raw data) collected strictly confidential and under no circumstances will we disclose individualised company-level information. The aggregated, company-neutral data will be analysed in the form of synopsis reports (presentations) and published in a dashboard.
Please note that the data set for the targeted evaluation is collected by the study team only once on behalf of DG SANTE. The pseudonymised raw data will be forwarded to DG SANTE for the analyses of the data.

*Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 (Medical devices regulation - MDR),
Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 (In vitro diagnostic medical devices regulation - IVDR)

To participate in the online survey

We hope to reach as many economic operators as possible and intend to keep the workload for completing the survey to a minimum.

Kindly provide only ONE answer per company and question. Please check internally with your colleagues to make sure that only one answer per company is provided.

You can download the current version of the survey questionnaire from the menu on your right.

Instructions on how to answer to the survey:

• Navigate through the questionnaire using the "next" buttons at the end of each page.

• To change replies, it is sufficient to go back to the question and modify it.

• A draft of the survey in progress can be saved via the dedicated button on the right end of each page. If you wish to pause the survey, please be sure to save your progress by clicking on the button “Save as draft” before closing your session: this will generate a personalised link with your survey draft. Re-loading the page after a time out will not recover previous answers. We recommend to save the progress and click on the new link provided by EUSurvey once you are ready to finish the survey.

• In some questions, additional instructions can be provided in italics (e.g.: select all that apply) – additional instructions will appear in case of errors in the answer (e.g.: “This is not a valid e-mail address.”).

• Fields marked with (*) are mandatory. In case of missing mandatory replies, an error message (“This field is required.”) in red is displayed on the relevant section of the question when the respondent moves forward in the questionnaire.

• To submit your replies please be sure to proceed until the very last page by clicking the “submit” button at the bottom of said page.

• After submitting the questionnaire, this message will be displayed: “We thank you for your time spent taking this survey. Your response has been recorded”. A summary of the replies is provided and can be downloaded in PDF or printed.

You can find a glossary of the terms used in this survey at the following link: here

Survey deadline: 21 March 2025 (23:59 CET)

Data protection, data processing and consent to participate

Acting in full compliance with EU competition law, and within its limits, we will keep any company-specific information (raw data) collected strictly confidential and under no circumstances will we disclose individualised company-level information. Only aggregated survey outcomes will be published in the data dashboard and analysis reports.

The project leader, the Austrian National Public Health Institute (Gesundheit Österreich GmbH / GÖG), is responsible for overall project management as well as the concept and analysis of the survey, Areté is providing support with consultation activities (implementation in EUSurvey tool, distributing surveys, data collection and pseudonymisation), while the third project partner (Civic Consulting) has no access to data.

This survey is run via the online tool EUSurvey. The raw data entered in the survey are stored on the servers of the European Commission’s Data Centre pursuant to the Commission Decision (EU, Euratom) 2017/46 of 10 January 2017 on the security of communication and information systems in the European Commission. More information is available at: https://ec.europa.eu/eusurvey/home/privacystatement.

Once the survey has closed, the raw data will be downloaded by a member of the project team bound by a duty obligation of confidentiality. In a second step, pseudonymisation will take place: identification and contact information (as provided in Questions 1a, 1b and 1c) will be deleted from the data file and replaced by an anonymous id code. A separate decoding document will be generated; only selected members of the project team will have access to the document for validation purposes. The decoding document will be handled with the utmost confidentiality and will not be shared, under any circumstances, with non-authorised personnel or with entities outside the study team.

The elaboration of survey replies will be based on the pseudonymised data file only.

The decoding document will be used to perform preliminary data validation activities (e.g., to check for double submissions). In the case of suspected double submissions, the project team will contact the company concerned for consultation. In the case of confirmed double submissions, the data entry concerned will be deleted after informing the company about the deletion.

During the elaboration of survey replies, ongoing validation of the pseudonymised data will take place to detect potential inconsistencies within the replies. Only in the case of severe concerns about a data entry will the survey reply concerned be decoded by an authorised member of the project team after, consulting the company concerned.

For the processing and subsequent publication, the data will be entered in aggregated form in the dashboard tool (using MS PowerBI). Before publication in the dashboard, the aggregated survey results are subject to review by DG SANTE and the MDCG TF on NB capacity monitoring. It is guaranteed that it will not be possible to trace back of individual companies in the aggregated data.

With the submission of your data/information you agree to these terms. We follow the EC privacy statement: https://ec.europa.eu/info/law/better-regulation/specific-privacy-statement_en

Contact

If you have any enquiries, please contact the study team via medical.devices@goeg.at.

Acronyms used:

AIMDD = Active Implantable Medical Device Directive

AR = Authorised Representative

CER = Clinical Evaluation Report
DB = Distributor

EMDN = European Medical Device Nomenclature

EU = European Union

IFU = Instructions for Use
IM = Importer

IVD = In Vitro Diagnostic Medical Device

IVDD = IVD Directive (EC) 98/79/EG

IVDR = IVD Regulation (EU) 2017/746

OEM = Original Equipment Manufacturer

OBL = Own Brand Labelling / Labelled

MD = Medical device

MDD = Medical Device Directive 93/42/EEC

MDR = MD Regulation (EU) 2017/745

MF = Manufacturer

PSUR = Periodic Safety Update Reports

SME = Small and Medium-Sized Enterprises*

SSCP = Summary of Safety and Clinical Performance

QMS = Quality Management System

*Definition: The category of micro, small and medium-sized enterprises (SMEs) is made up of enterprises which employ fewer than 250 persons and which have an annual turnover not exceeding EUR 50 million, and/or an annual balance sheet total not exceeding EUR 43 million. (Source: Extract of from Article 2 from the Annex to Recommendation 2003/361/EC)

We value your privacy. This information will be used to identify / delete any double submissions by the same company/subsidiaries. We may contact you in case we have any questions about your submission or to send you survey results. We will not share your personal details - they will be deleted as soon as they are no longer needed to process the results. Full anonymity is guaranteed.