Horizon Scanning for Medical Devices and In Vitro Diagnostic Medical Devices

The aim of this call for tenders is to purchase horizon scanning in the area of medical devices and in vitro diagnostic medical devices in order to maintain an up-to-date overview of new and emerging technologies. The contractor will have to screen available sources for identification of novel, emerging technologies, …

CPV: 33190000 Diverse medicinktekniska produkter, 72000000 IT-tjänster: konsultverksamhet, programvaruutveckling, Internet och stöd, 85100000 Hälsovårdstjänster
Plats för avrättning:
Horizon Scanning for Medical Devices and In Vitro Diagnostic Medical Devices
Plats för tilldelning:
Health and Digital Executive Agency (HaDEA) , HADEA - Health and Digital Executive Agency
Tilldelningsnummer:
HADEA/2024/OP/0024

1. Buyer

1.1 Buyer

Official name : Health and Digital Executive Agency (HaDEA) , HADEA - Health and Digital Executive Agency
Legal type of the buyer : EU institution, body or agency
Activity of the contracting authority : General public services

2. Procedure

2.1 Procedure

Title : Horizon Scanning for Medical Devices and In Vitro Diagnostic Medical Devices
Description : The aim of this call for tenders is to purchase horizon scanning in the area of medical devices and in vitro diagnostic medical devices in order to maintain an up-to-date overview of new and emerging technologies. The contractor will have to screen available sources for identification of novel, emerging technologies, and assess features that may have an impact on medical devices and in vitro diagnostic medical devices, present opportunities, risks or other features related to new and emerging technologies. The need for this horizon scanning has been identified in the context of the implementation of the MDR/IVDR legislation in order to support competitiveness and innovation in the EU market, while ensuring a high level of protection of health for patients and users.
Procedure identifier : 399e3dae-d6dc-428e-9854-a84e40097783
Previous notice : 675179-2024
Internal identifier : HADEA/2024/OP/0024
Type of procedure : Open
Justification for the accelerated procedure :
Main features of the procedure :

2.1.1 Purpose

Main nature of the contract : Services
Main classification ( cpv ): 85100000 Health services

2.1.2 Place of performance

Anywhere
Additional information : Please consult the procurement documents.

2.1.3 Value

Estimated value excluding VAT : 1 000 000 Euro

2.1.4 General information

Legal basis :
Regulation (EU, Euratom) 2024/2509

5. Lot

5.1 Lot technical ID : LOT-0001

Title : Horizon Scanning for Medical Devices and In Vitro Diagnostic Medical Devices
Description : The aim of this call for tenders is to purchase horizon scanning in the area of medical devices and in vitro diagnostic medical devices in order to maintain an up-to-date overview of new and emerging technologies. The contractor will have to screen available sources for identification of novel, emerging technologies, and assess features that may have an impact on medical devices and in vitro diagnostic medical devices, present opportunities, risks or other features related to new and emerging technologies. The need for this horizon scanning has been identified in the context of the implementation of the MDR/IVDR legislation in order to support competitiveness and innovation in the EU market, while ensuring a high level of protection of health for patients and users.
Internal identifier : HADEA/2024/OP/0024

5.1.1 Purpose

Main nature of the contract : Services
Main classification ( cpv ): 85100000 Health services
Additional classification ( cpv ): 33190000 Miscellaneous medical devices and products
Additional classification ( cpv ): 72000000 IT services: consulting, software development, Internet and support

5.1.2 Place of performance

Anywhere
Additional information : Please consult the procurement documents.

5.1.3 Estimated duration

Duration : 30 Month

5.1.5 Value

Estimated value excluding VAT : 1 000 000 Euro

5.1.6 General information

Procurement Project fully or partially financed with EU Funds.
The procurement is covered by the Government Procurement Agreement (GPA) : no
Information about previous notices :
Identifier of the previous notice : 335951-2024

5.1.10 Award criteria

Criterion :
Type : Quality
Name :
Description : Please consult the procurement documents.
Category of award threshold criterion : Weight (percentage, exact)
Award criterion number : 70
Criterion :
Type : Price
Name :
Description : Please consult the procurement documents.
Category of award threshold criterion : Weight (percentage, exact)
Award criterion number : 30
Description of the method to be used if weighting cannot be expressed by criteria :
Justification for not indicating the weighting of the award criteria :

5.1.15 Techniques

Framework agreement :
No framework agreement
Information about the dynamic purchasing system :
No dynamic purchase system

5.1.16 Further information, mediation and review

Review organisation : Court of Justice of the European Union -
Organisation providing more information on the review procedures : Health and Digital Executive Agency (HaDEA) , HADEA - Health and Digital Executive Agency -
Organisation signing the contract : Health and Digital Executive Agency (HaDEA) , HADEA - Health and Digital Executive Agency

6. Results

Value of all contracts awarded in this notice : 896 400 Euro

6.1 Result lot ldentifier : LOT-0001

At least one winner was chosen.

6.1.2 Information about winners

Winner :
Leader of tendering party : TECHNOPOLIS FRANCE
Official name : EMPIRICA GESELLSCHAFT FUR KOMMUNIKATIONS UND TECHNOLOGIEFORSCHUNGMBH PREDICTBY RESEARCH AND CONSULTINGS.L. TECHNOPOLIS BV
Tender :
Tender identifier : Joint tender led by Technopolis France
Identifier of lot or group of lots : LOT-0001
Value of the tender : 896 400 Euro
Subcontracting : Yes
Subcontracting value is known : no
Subcontracting percentage is known : yes
Percentage of subcontracting : 25
Contract information :
Identifier of the contract : HADEA/2024/OP/0024
Date on which the winner was chosen : 22/05/2025
Date of the conclusion of the contract : 06/06/2025
Information about European Union funds
Name of EU-financed project or programme : EU4Health Programme (2021/2027)
Organisation signing the contract : Health and Digital Executive Agency (HaDEA) , HADEA - Health and Digital Executive Agency

6.1.4 Statistical information

Received tenders or requests to participate :
Type of received submissions : Tenders submitted electronically
Number of tenders or requests to participate received : 7

8. Organisations

8.1 ORG-0001

Official name : Health and Digital Executive Agency (HaDEA) , HADEA - Health and Digital Executive Agency
Registration number : HADEA
Department : HADEA - Directorate of HaDEA,HADEA.A - Health and Food,HADEA.A.2 - EU4Health/SMP Food
Postal address : COV2, Place Charles Rogier 16
Town : Brussels
Postcode : B-1210
Country subdivision (NUTS) : Arr. de Bruxelles-Capitale/Arr. Brussel-Hoofdstad ( BE100 )
Country : Belgium
Telephone : +32 2 299 11 11
Internet address : https://hadea.ec.europa.eu
Roles of this organisation :
Buyer
Organisation providing more information on the review procedures
Organisation signing the contract

8.1 ORG-0002

Official name : Court of Justice of the European Union
Registration number : CURIA
Postal address : Rue du Fort Niedergrünewald
Town : Luxembourg
Postcode : L-2925
Country subdivision (NUTS) : Luxembourg ( LU000 )
Country : Luxembourg
Telephone : +352 4303-1
Internet address : http://curia.europa.eu
Roles of this organisation :
Review organisation

8.1 ORG-0003

Official name : European Commission
Registration number : EUCOM
Postal address : Mondrian (CDMA), Rue du Champ de Mars 21
Town : Brussels
Postcode : B-1050
Country subdivision (NUTS) : Arr. de Bruxelles-Capitale/Arr. Brussel-Hoofdstad ( BE100 )
Country : Belgium
Telephone : +32 2 299 11 11
Roles of this organisation :
TED eSender

8.1 ORG-0004

Official name : TECHNOPOLIS FRANCE
Size of the economic operator : Large
Registration number : FR68419706635
Postal address : 60-62 BOULEVARD DIDEROT
Town : PARIS
Postcode : 75012
Country subdivision (NUTS) : Extra-Regio NUTS 3 ( FRZZZ )
Country : France
Telephone : +33149490920
Roles of this organisation :
Tenderer
Group leader
Winner of these lots : LOT-0001

8.1 ORG-0005

Official name : EMPIRICA GESELLSCHAFT FUR KOMMUNIKATIONS UND TECHNOLOGIEFORSCHUNGMBH
Size of the economic operator : Large
Registration number : DE122113895
Postal address : OXFORDSTRASSE 2
Town : BONN
Postcode : 53111
Country subdivision (NUTS) : Extra-Regio NUTS 3 ( DEZZZ )
Country : Germany
Telephone : +33149490920
Roles of this organisation :
Tenderer
Winner of these lots : LOT-0001

8.1 ORG-0006

Official name : PREDICTBY RESEARCH AND CONSULTINGS.L.
Size of the economic operator : Large
Registration number : ESB09869355
Postal address : CL LLACUNA NUM.118 P.1 PTA.1
Town : BARCELONA
Postcode : 08018
Country subdivision (NUTS) : Extra-Regio NUTS 3 ( ESZZZ )
Country : Spain
Telephone : +33149490920
Roles of this organisation :
Tenderer
Winner of these lots : LOT-0001

8.1 ORG-0007

Official name : TECHNOPOLIS BV
Size of the economic operator : Large
Registration number : NL804952243B01
Postal address : SPUISTRAAT 283
Town : AMSTERDAM
Postcode : 1012 VR
Country subdivision (NUTS) : Extra-Regio NUTS 3 ( NLZZZ )
Country : Netherlands
Telephone : +33149490920
Roles of this organisation :
Tenderer
Winner of these lots : LOT-0001
Notice information
Notice identifier/version : 93393b4c-b384-4831-93f8-595f201a95ab - 01
Form type : Result
Notice type : Contract or concession award notice – standard regime
Notice dispatch date : 12/06/2025 14:07 +02:00
Languages in which this notice is officially available : English
Notice publication number : 00383490-2025
OJ S issue number : 112/2025
Publication date : 13/06/2025