EU Notified Body designated under Regulation (EU) 2017/746 (IVDR)

{
  "id": "008003-2025",
  "tag": [
    "planning"
  ],
  "date": "2025-03-05T11:15:07Z",
  "ocid": "ocds-h6vhtk-04e9b3",
  "buyer": {
    "id": "GB-PPON-PDBY-6395-VWBP",
    "name": "NHS Blood and Transplant"
  },
  "tender": {
    "id": "C343711",
    "lots": [
      {
        "id": "1",
        "status": "planning",
        "contractPeriod": {
          "endDate": "2029-05-18T23:59:59+01:00",
          "startDate": "2025-05-19T00:00:00+01:00"
        }
      }
    ],
    "items": [
      {
        "id": "1",
        "relatedLot": "1",
        "deliveryAddresses": [
          {
            "region": "UK",
            "country": "GB",
            "countryName": "United Kingdom"
          }
        ],
        "additionalClassifications": [
          {
            "id": "71630000",
            "scheme": "CPV",
            "description": "Technical inspection and testing services"
          },
          {
            "id": "72225000",
            "scheme": "CPV",
            "description": "System quality assurance assessment and review services"
          }
        ]
      }
    ],
    "title": "EU Notified Body designated under Regulation (EU) 2017/746 (IVDR)",
    "value": {
      "amount": 140000,
      "currency": "GBP",
      "amountGross": 168000
    },
    "status": "planning",
    "legalBasis": {
      "id": "2023/54",
      "uri": "https://www.legislation.gov.uk/ukpga/2023/54/contents",
      "scheme": "UKPGA"
    },
    "description": "NHS Blood and Transplant (NHSBT) is seeking to engage with an EU Notified Body designated under Regulation (EU) 2017/746 (IVDR) to undertake conformity assessment of in vitro diagnostic medical devices (IVDs) and appropriate surveillance of legacy IVDs. NHSBT is a Special Health Authority that provides a blood and transplantation service to the NHS, looking after blood donation services in England and transplant services across the UK. NHSBT Reagents is a specialist department within NHSBT that designs, manufactures and distributes in vitro diagnostic medical devices for transfusion and transplantation investigations including blood grouping control reagents. NHSBT require the services of an EU Notified Body for conformity assessment and CE-certification of IVDs under the IVDR, and for appropriate surveillance of legacy IVDs.",
    "communication": {
      "futureNoticeDate": "2025-03-24T23:59:59Z"
    },
    "aboveThreshold": true,
    "mainProcurementCategory": "services"
  },
  "parties": [
    {
      "id": "GB-PPON-PDBY-6395-VWBP",
      "name": "NHS Blood and Transplant",
      "roles": [
        "buyer"
      ],
      "address": {
        "region": "UKK12",
        "country": "GB",
        "locality": "Bristol",
        "postalCode": "BS34 7QH",
        "countryName": "United Kingdom",
        "streetAddress": "500 North Bristol Park"
      },
      "details": {
        "url": "https://www.nhsbt.nhs.uk/",
        "classifications": [
          {
            "id": "publicAuthorityCentralGovernment",
            "scheme": "UK_CA_TYPE",
            "description": "Public authority - central government"
          }
        ]
      },
      "identifier": {
        "id": "PDBY-6395-VWBP",
        "scheme": "GB-PPON"
      },
      "contactPoint": {
        "name": "Rowena Thomas",
        "email": "rowena.thomas@nhsbt.nhs.uk",
        "telephone": "07553 520488"
      }
    }
  ],
  "language": "en",
  "planning": {
    "documents": [
      {
        "id": "008003-2025",
        "url": "https://www.find-tender.service.gov.uk/Notice/008003-2025",
        "format": "text/html",
        "noticeType": "UK2",
        "description": "Preliminary market engagement notice on Find a Tender",
        "documentType": "marketEngagementNotice",
        "datePublished": "2025-03-05T11:15:07Z"
      }
    ],
    "milestones": [
      {
        "id": "engagement",
        "type": "engagement",
        "status": "scheduled",
        "dueDate": "2025-03-14T23:59:59Z",
        "description": "Interested suppliers are asked to express their interest to rowena.thomas@nhsbt.nhs.uk and carley.butcher@nhsbt.nhs.uk by 12:00 noon on Friday, 14th March 2025. Suppliers expressing an interest will be invited to attend an early market engagement exercise supplier meeting on Wednesday, 19th March 2025 (note: date subject to change). Prior to this session, interested suppliers will be provided with a draft specification of requirements and short questionnaire related to requirements. There is no guarantee that a formal procurement process will be launched as a result of this early market engagement exercise, nor that any contract(s) will be placed. No remuneration or compensation etc will be paid to organisations who take part in this early market engagement exercise. Suppliers should take part in this process only on the basis that they fully understand and accept this position."
      }
    ]
  },
  "initiationType": "tender"
}