Service contract to translate and validate the European medical device nomenclature (EMDN) and the International medical device regulators forum (IMDRF) adverse events terminologies in official EU languages

This action aims at facilitating the use of European harmonised medical device nomenclatures (EMDN) and the International medical device regulators forum’s adverse event (IMDRF AE) terminologies by all stakeholders. It includes the review and harmonisation of the existing translated versions of the EMDN and the translation and validation of the …

CPV: 33000000 Equipamiento y artículos médicos, farmacéuticos y de higiene personal, 79530000 Servicios de traducción, 85100000 Servicios de salud, 85120000 Servicios de ejercicio de la medicina y servicios conexos
Plazo:
10 de marzo de 2025 a las 16:00
Tipo de plazo:
Presentación de una oferta
Lugar de ejecución:
Service contract to translate and validate the European medical device nomenclature (EMDN) and the International medical device regulators forum (IMDRF) adverse events terminologies in official EU languages
Organismo adjudicador:
Health and Digital Executive Agency (HaDEA) , HADEA - Health and Digital Executive Agency
Número de premio:
HADEA/2024/OP/0026

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 : Service contract to translate and validate the European medical device nomenclature (EMDN) and the International medical device regulators forum (IMDRF) adverse events terminologies in official EU languages
Description : This action aims at facilitating the use of European harmonised medical device nomenclatures (EMDN) and the International medical device regulators forum’s adverse event (IMDRF AE) terminologies by all stakeholders. It includes the review and harmonisation of the existing translated versions of the EMDN and the translation and validation of the seven IMDRF AE terminologies to EU official languages. Specialised expertise in the medical sector (medical devices and clinical aspects) is necessary to conduct both tasks.
Procedure identifier : ec200395-d29e-4813-8a01-4b30b1482621
Internal identifier : HADEA/2024/OP/0026
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 ): 79530000 Translation services

2.1.3 Value

Estimated value excluding VAT : 800 000 Euro

2.1.4 General information

Additional information : The legal basis for this call for tenders is Financial Regulation (FR) 2024/2509. Reference to FR 2018/1046 in this section should be disregarded.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 : Service contract to translate and validate the European medical device nomenclature (EMDN) and the International medical device regulators forum (IMDRF) adverse events terminologies in official EU languages
Description : This action aims at facilitating the use of European harmonised medical device nomenclatures (EMDN) and the International medical device regulators forum’s adverse event (IMDRF AE) terminologies by all stakeholders. It includes the review and harmonisation of the existing translated versions of the EMDN and the translation and validation of the seven IMDRF AE terminologies to EU official languages. Specialised expertise in the medical sector (medical devices and clinical aspects) is necessary to conduct both tasks.
Internal identifier : HADEA/2024/OP/0026

5.1.1 Purpose

Main nature of the contract : Services
Main classification ( cpv ): 79530000 Translation services
Additional classification ( cpv ): 33000000 Medical equipments, pharmaceuticals and personal care products
Additional classification ( cpv ): 85100000 Health services
Additional classification ( cpv ): 85120000 Medical practice and related services
Options :
Description of the options : provided they are in conformity with the basic project, new services or works consisting in the repetition of similar services or works, may be entrusted up to 50 % of the initial contract to the initial contractor by negotiated procedure without prior publication of a contract notice.

5.1.3 Estimated duration

Duration : 30 Month

5.1.5 Value

Estimated value excluding VAT : 800 000 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 : 374643-2024

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 : 10/03/2025 16:00 +01:00
Deadline until which the tender must remain valid : 6 Month
Information about public opening :
Opening date : 11/03/2025 14:30 +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 : b8b27bf5-c7e0-4d2d-9b26-a69451b63ea1 - 01
Form type : Competition
Notice type : Contract or concession notice – standard regime
Notice dispatch date : 18/12/2024 08:22 +01:00
Languages in which this notice is officially available : English

11.2 Publication information

Notice publication number : 00779288-2024
OJ S issue number : 247/2024
Publication date : 19/12/2024