The Contracting Authority proposes to engage in a competitive process for the establishment of a Multi-Operator Framework Agreement for the provision of Quality and Regulatory Consultancy Services focused on medical device prototypes. These services will support device development across clinical, regulatory, and commercial planning pathways in accordance with applicable EU and international regulatory requirements. All participants on the framework when established will be required to sign a NDA. Please refer to attached documentation for further information.
Contract notice (2026-04-17) Object Scope of the procurement
Title: 268/26 ATU Multi Party Framework Agreement for the Provision of Quality and Regulation Consultancy Services for Medical Technologies
Short description:
โThe Contracting Authority proposes to engage in a competitive process for the establishment of a Multi-Operator Framework Agreement for the provision of...โ
Short description
The Contracting Authority proposes to engage in a competitive process for the establishment of a Multi-Operator Framework Agreement for the provision of Quality and Regulatory Consultancy Services focused on medical device prototypes. These services will support device development across clinical, regulatory, and commercial planning pathways in accordance with applicable EU and international regulatory requirements. All participants on the framework when established will be required to sign a NDA. Please refer to attached documentation for further information.
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Type of contract: Services
Products/services: Research and development consultancy services๐ฆ
Estimated value excluding VAT: 500 000 EUR ๐ฐ
Description
Description of the procurement:
โThe Contracting Authority proposes to engage in a competitive process for the establishment of a Multi-Operator Framework Agreement for the provision of...โ
Description of the procurement
The Contracting Authority proposes to engage in a competitive process for the establishment of a Multi-Operator Framework Agreement for the provision of Quality and Regulatory Consultancy Services focused on medical device prototypes. These services will support device development across clinical, regulatory, and commercial planning pathways in accordance with applicable EU and international regulatory requirements. All participants on the framework when established will be required to sign a NDA. Please refer to attached documentation for further information.
Procedure Type of procedure
Open procedure โ Administrative information
Time limit for receipt of tenders or requests to participate: 2026-05-18 12:00:00 ๐
Conditions for opening of tenders: 2026-05-18 12:30:00 ๐
Conditions for opening of tenders (place): https://www.etenders.gov.ie/epps/cft/prepareViewCfTWS.do?resourceId=7826886
Languages in which tenders or requests to participate may be submitted: English ๐ฃ๏ธ
Minimum time frame during which the tenderer must maintain the tender: 12
Information about a framework agreement or a dynamic purchasing system
Framework agreement with several operators โ Description
In the case of framework agreements, provide justification for any duration exceeding 4 years:
โThe five-year term is justified by the ongoing and iterative nature of quality and regulatory consultancy support required for medical technologies, where...โ
In the case of framework agreements, provide justification for any duration exceeding 4 years
The five-year term is justified by the ongoing and iterative nature of quality and regulatory consultancy support required for medical technologies, where sustained access to specialist expertise is necessary to maintain compliance, manage change, and support repeated procurement and development needs throughout the framework period.
Complementary information Review body
Name: The High Court of Ireland
National registration number: The High Court of Ireland
Postal address: Four Courts, Inns Quay, Dublin 7
Postal code: D07 WDX8
Postal town: Dublin
Region: Dublin๐๏ธ
Country: Ireland ๐ฎ๐ช
E-mail: highcourtcentraloffice@courts.ie๐ง
Phone: +353 1 8886000๐ Service from which information about the review procedure may be obtained
Name: The High Court of Ireland
National registration number: The High Court of Ireland
Postal address: Four Courts, Inns Quay, Dublin 7
Postal code: D07 WDX8
Postal town: Dublin
Region: Dublin๐๏ธ
Country: Ireland ๐ฎ๐ช
E-mail: highcourtcentraloffice@courts.ie๐ง
Phone: +353 1 8886000๐ Information about electronic workflows
Electronic invoicing will be accepted
Electronic ordering will be used
Electronic payment will be used
Source: OJS 2026/S 076-266266 (2026-04-17)