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

{
  "buyer": {
    "id": "GB-PPON-PDBY-6395-VWBP",
    "name": "NHS Blood and Transplant"
  },
  "date": "2025-03-27T16:58:21Z",
  "id": "011644-2025",
  "initiationType": "tender",
  "language": "en",
  "ocid": "ocds-h6vhtk-04e9b4",
  "parties": [
    {
      "address": {
        "country": "GB",
        "countryName": "United Kingdom",
        "locality": "Bristol",
        "postalCode": "BS34 7QH",
        "region": "UKK12",
        "streetAddress": "500 North Bristol Park"
      },
      "contactPoint": {
        "email": "rowena.thomas@nhsbt.nhs.uk",
        "name": "Rowena Thomas",
        "telephone": "07553520488"
      },
      "details": {
        "classifications": [
          {
            "description": "Public authority - central government",
            "id": "publicAuthorityCentralGovernment",
            "scheme": "UK_CA_TYPE"
          }
        ],
        "url": "https://www.nhsbt.nhs.uk/"
      },
      "id": "GB-PPON-PDBY-6395-VWBP",
      "identifier": {
        "id": "PDBY-6395-VWBP",
        "scheme": "GB-PPON"
      },
      "name": "NHS Blood and Transplant",
      "roles": [
        "buyer"
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    }
  ],
  "tag": [
    "tender"
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  "tender": {
    "aboveThreshold": true,
    "awardPeriod": {
      "endDate": "2025-05-06T23:59:59+01:00"
    },
    "contractTerms": {
      "financialTerms": "30 day payment terms, paid monthly based on services provided"
    },
    "coveredBy": [
      "GPA"
    ],
    "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\u2019s current EU Notified Body has not been designated under the IVDR and we require the services of an alternative EU Notified Body for conformity assessment and CE-certification of IVDs under the IVDR, and for appropriate surveillance of legacy IVDs (i.e. IVDs that are covered by a certificate issued by a Notified Body in accordance with Directive 98/79/EC (IVDD) and which comply with the conditions set out in Article 110 (3c) of the IVDR). It is imperative that NHSBT is able to lodge a formal application for conformity assessment and sign a written agreement with an alternative EU Notified Body in accordance with deadlines set out in the Article 110 (3c) point (e) and Article 110 (3c) point (f) of the IVDR, respectively. This will enable NHSBT to benefit from the extended transitional period provided for in the IVDR, as amended by Regulation (EU) 2024/1860. The device risk class, IVDR transitional deadlines and number of devices / products are summarised in the tender documents. The EU Notified Body\u2019s designation must cover the scope of designation applicable to the IVDs manufactured by NHSBT which is summarised as follows: \u2022 NBOG Codes that apply to legacy devices; IVD0101, IVD0102, IVD0302, MDS7210. \u2022 IVDR Codes that apply to the IVDR devices; IVR0101, IVR0102, IVR0103, IVR0104, IVR0105, IVR0106, IVS1004, IVT2006, IVT2008, IVT2009, IVT2011, IVP3001, IVP3006 (note: not all codes apply to all devices). NHSBT\u2019s requirements are summarised below: \u2022 Surveillance assessment of legacy devices during the transitional period. \u2022 Assessment of NHSBT\u2019s Quality Management System. \u2022 Undertake announced and unannounced audits. \u2022 Conformity assessment and CE-certification of NHSBT\u2019s IVDs. \u2022 Surveillance assessment of IVDR CE-certified IVDs (following initial certification). \u2022 Batch / product verification for Class D devices. \u2022 Validate the Summary of Safety and Performance for Class D and C devices. \u2022 Assess and approve (or reject) proposed/planned substantial changes to NHSBT Reagents product range, products or Quality Management System.",
    "documents": [
      {
        "description": "Not published",
        "documentType": "conflictOfInterest",
        "id": "conflictOfInterest"
      },
      {
        "datePublished": "2025-03-27T16:58:21Z",
        "description": "Tender notice on Find a Tender",
        "documentType": "tenderNotice",
        "format": "text/html",
        "id": "011644-2025",
        "noticeType": "UK4",
        "url": "https://www.find-tender.service.gov.uk/Notice/011644-2025"
      }
    ],
    "enquiryPeriod": {
      "endDate": "2025-04-16T12:00:00+01:00"
    },
    "hasRecurrence": true,
    "id": "C343711",
    "items": [
      {
        "additionalClassifications": [
          {
            "description": "System quality assurance assessment and review services",
            "id": "72225000",
            "scheme": "CPV"
          },
          {
            "description": "Technical inspection and testing services",
            "id": "71630000",
            "scheme": "CPV"
          }
        ],
        "id": "1",
        "relatedLot": "1"
      }
    ],
    "legalBasis": {
      "id": "2023/54",
      "scheme": "UKPGA",
      "uri": "https://www.legislation.gov.uk/ukpga/2023/54/contents"
    },
    "lots": [
      {
        "awardCriteria": {
          "criteria": [
            {
              "name": "Price",
              "numbers": [
                {
                  "number": 60.0,
                  "weight": "percentageExact"
                }
              ],
              "type": "price"
            },
            {
              "name": "Quality",
              "numbers": [
                {
                  "number": 30.0,
                  "weight": "percentageExact"
                }
              ],
              "type": "quality"
            },
            {
              "name": "Social Value",
              "numbers": [
                {
                  "number": 10.0,
                  "weight": "percentageExact"
                }
              ],
              "type": "quality"
            }
          ]
        },
        "contractPeriod": {
          "endDate": "2027-05-25T23:59:59+01:00",
          "maxExtentDate": "2029-05-25T23:59:59+01:00",
          "startDate": "2025-05-26T00:00:00+01:00"
        },
        "hasOptions": true,
        "hasRenewal": true,
        "id": "1",
        "options": {
          "description": "2 x 12 monthly or cumulative extension to a maximum 4 year contract"
        },
        "renewal": {
          "description": "2 x 12 monthly or cumulative extension to a maximum 4 year contract"
        },
        "status": "active",
        "value": {
          "amount": 160000.0,
          "amountGross": 192000.0,
          "currency": "GBP"
        }
      }
    ],
    "mainProcurementCategory": "services",
    "procurementMethod": "open",
    "procurementMethodDetails": "Open procedure",
    "recurrence": {
      "dates": [
        {
          "startDate": "2029-01-01T23:59:59Z"
        }
      ]
    },
    "riskDetails": "Due to the nature of the contract and the unknown hours of work that may be required to undertake the assessments, there is a risk that the predicted whole life costs used to calculate the potential contract value may be exceeded.",
    "status": "active",
    "submissionMethodDetails": "https://atamis-1928.my.site.com/s/Welcome",
    "submissionTerms": {
      "electronicSubmissionPolicy": "allowed",
      "languages": [
        "en"
      ]
    },
    "tenderPeriod": {
      "endDate": "2025-04-24T12:00:00+01:00"
    },
    "title": "EU Notified Body designated under Regulation (EU) 2017/746 (IVDR)",
    "value": {
      "amount": 160000.0,
      "amountGross": 192000.0,
      "currency": "GBP"
    }
  }
}