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: 85100000 Health services, 33190000 Miscellaneous medical devices and products, 72000000 IT services: consulting, software development, Internet and support
Deadline:
Jan. 16, 2025, 3 p.m.
Deadline type:
Submitting a bid
Place of execution:
Horizon Scanning for Medical Devices and In Vitro Diagnostic Medical Devices
Awarding body:
Health and Digital Executive Agency (HaDEA) , HADEA - Health and Digital Executive Agency
Award number:
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
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

2.1.3 Value

Estimated value excluding VAT : 1 000 000 Euro

2.1.4 General information

Additional information : In case of unavailability or disruptions in the functioning of the electronic means of communication provided in Section 5.1.11 in the last 5 calendar days before the time limit for receipt indicated in Section 5.1.12, the contracting authority reserves the right to extend this time limit and publish the extension at the Internet address provided in Section 5.1.11, without a preceding publication of a corrigendum to this notice. Economic operators interested in this procurement are invited to subscribe to the call for tenders at the address in Section 5.1.11 in order to get notified when new information or documents are published.
Legal basis :
Regulation (EU, Euratom) 2018/1046

2.1.6 Grounds for exclusion

Bankruptcy : For the full list of exclusion grounds please consult the procurement documents.

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

5.1.3 Estimated duration

Duration : 30 Month

5.1.5 Value

Estimated value excluding VAT : 1 000 000 Euro

5.1.6 General information

Reserved participation : Participation is not reserved.
Procurement Project fully or partially financed with EU Funds.
Information about European Union funds
EU funds programme : EU4Health Programme (2021/2027)
The procurement is covered by the Government Procurement Agreement (GPA) : no
Information about previous notices :
Identifier of the previous notice : 335951-2024

5.1.9 Selection criteria

Criterion :
Type : Suitability to pursue the professional activity
Description : Please consult the procurement documents.
Criterion :
Type : Economic and financial standing
Description : Please consult the procurement documents.
Criterion :
Type : Technical and professional ability
Description : Please consult the procurement documents.

5.1.10 Award criteria

Criterion :
Type : Quality
Name :
Description : Please consult the procurement documents.
Weight (percentage, exact) : 70
Criterion :
Type : Price
Name :
Description : Please consult the procurement documents.
Weight (percentage, exact) : 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 :

5.1.11 Procurement documents

5.1.12 Terms of procurement

Terms of submission :
Electronic submission : Required
Languages in which tenders or requests to participate may be submitted : Bulgarian, Czech, Danish, German, Greek, English, Spanish, Estonian, Finnish, French, Irish, Croatian, Hungarian, Italian, Lithuanian, Latvian, Maltese, Dutch, Polish, Portuguese, Romanian, Slovak, Slovenian, Swedish
Electronic catalogue : Not allowed
Deadline for receipt of tenders : 16/01/2025 15:00 +01:00
Deadline until which the tender must remain valid : 6 Month
Information about public opening :
Opening date : 17/01/2025 11:00 +01:00
Terms of contract :
The execution of the contract must be performed within the framework of sheltered employment programmes : No
Electronic invoicing : Allowed
Electronic ordering will be used : no
Electronic payment will be used : yes

5.1.15 Techniques

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

5.1.16 Further information, mediation and review

Review organisation : Court of Justice of the European Union
TED eSender : European Commission

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

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

11. Notice information

11.1 Notice information

Notice identifier/version : e7b317de-3c57-49c5-8094-7cc589ee9b46 - 01
Form type : Competition
Notice type : Contract or concession notice – standard regime
Notice dispatch date : 05/11/2024 10:12 +01:00
Languages in which this notice is officially available : English

11.2 Publication information

Notice publication number : 00675179-2024
OJ S issue number : 216/2024
Publication date : 06/11/2024