Germany – Technical inspection services – Rahmenvertrag für Prüfdienstleistungen Medizin- und Labortechnik

Technical Audit Medical Devices

Service category: 79

Type of contract: Services

Short description: The contract concerns the performance of a technical audit of medical devices in the area of the contracting authority. The audit includes the review of the technical documentation and the assessment of the medical devices in accordance with the relevant legal requirements and standards. The audit is to be carried out by a notified body in accordance with the Medical Devices Regulation (MDR) (EU) 2017/745.

The audit is to be carried out in the period from 01.01.2024 to 31.12.2024. The total estimated value of the contract is EUR 50 000.00 (excluding VAT).

The contract is to be awarded to a notified body that has been designated by a competent authority in accordance with the MDR (EU) 2017/745. The notified body must have the necessary expertise and experience in the field of medical devices and must be able to demonstrate this through appropriate references and certificates.

The contract is to be awarded in accordance with the Public Procurement Act (Bundesvergabegesetz - BVergG) and the relevant regulations of the European Union. The contract is to be awarded through a restricted procedure in accordance with Section 11 of the BVergG.

The contract is to be awarded to a notified body that has been designated by a competent authority in accordance with the MDR (EU) 2017/745. The notified body must have the necessary expertise and experience in the field of medical devices and must be able to demonstrate this through appropriate references and certificates.

The contract is to be awarded to a notified body that has been designated by a competent authority in accordance with the MDR (EU) 2017/745. The notified body must have the necessary expertise and experience in the field of medical devices and must be able to demonstrate this through appropriate references and certificates.

The contract is to be awarded to a notified body that has been designated by a competent authority in accordance with the MDR (EU) 2017/745. The notified body must have the necessary expertise and experience in the field of medical devices and must be able to demonstrate this through appropriate references and certificates.

The contract is to be awarded to a notified body that has been designated by a competent authority in accordance with the MDR (EU) 2017/745. The notified body must have the necessary expertise and experience in the field of medical devices and must be able to demonstrate this through appropriate references and certificates.