Regulatory Compliance Services for Medical Devices

{
  "id": "058183-2026",
  "tag": [
    "award",
    "contract"
  ],
  "date": "2026-06-19T15:03:16+01:00",
  "ocid": "ocds-h6vhtk-06b95e",
  "buyer": {
    "id": "GB-PPON-PDPT-3135-BWWY",
    "name": "NHS England"
  },
  "awards": [
    {
      "id": "1",
      "items": [
        {
          "id": "1",
          "relatedLot": "1",
          "additionalClassifications": [
            {
              "id": "85100000",
              "scheme": "CPV",
              "description": "Health services"
            }
          ]
        }
      ],
      "status": "active",
      "suppliers": [
        {
          "id": "GB-FTS-183585",
          "name": "SCARLET GLOBAL HOLDINGS LTD"
        }
      ],
      "relatedLots": [
        "1"
      ],
      "mainProcurementCategory": "services"
    }
  ],
  "tender": {
    "id": "C447688",
    "lots": [
      {
        "id": "1",
        "status": "complete"
      }
    ],
    "title": "Regulatory Compliance Services for Medical Devices",
    "status": "complete",
    "legalBasis": {
      "id": "2023/54",
      "uri": "https://www.legislation.gov.uk/ukpga/2023/54/contents",
      "scheme": "UKPGA"
    },
    "description": "The procurement covers regulatory compliance services for medical devices, specifically the engagement of a UK Approved Body to conduct a two-stage external audits (Stage 1 and Stage 2) in line with agreed timelines, to urgently achieve ISO 13485 Quality Management System certification. The deliverables will ensure that our medical devices are safe, effective, reliable and meet internationally recognized standard.\nWith the UK medical device regulations set to change in Spring 2026, several currently self-certified, low-risk SaMDs will be reclassified as higher-risk devices. This means external certification by a UK Approved Body (e.g., BSI) will become mandatory. Failure to achieve this will result in an “innovation freeze,” preventing the introduction of new or updated SaMDs and AIaMDs, and exposing NHS England to significant legal, reputational, and operational risks. This is not a discretionary activity—it is a statutory obligation",
    "procurementMethod": "limited",
    "procurementMethodDetails": "Below threshold - limited competition"
  },
  "parties": [
    {
      "id": "GB-PPON-PDPT-3135-BWWY",
      "name": "NHS England",
      "roles": [
        "buyer"
      ],
      "address": {
        "region": "UKI45",
        "country": "GB",
        "locality": "London",
        "postalCode": "SE1 8UG",
        "countryName": "United Kingdom",
        "streetAddress": "Wellington House, 133-135 Waterloo Rd"
      },
      "details": {
        "url": "https://www.england.nhs.uk/",
        "classifications": [
          {
            "id": "publicAuthorityCentralGovernment",
            "scheme": "UK_CA_TYPE",
            "description": "Public authority - central government"
          }
        ]
      },
      "identifier": {
        "id": "PDPT-3135-BWWY",
        "scheme": "GB-PPON"
      },
      "contactPoint": {
        "email": "england.commercialqueries@nhs.net"
      }
    },
    {
      "id": "GB-FTS-183585",
      "name": "SCARLET GLOBAL HOLDINGS LTD",
      "roles": [
        "supplier"
      ],
      "address": {
        "region": "UKI31",
        "country": "GB",
        "locality": "London",
        "postalCode": "EC4A 1JP",
        "countryName": "United Kingdom",
        "streetAddress": "12 New Fetter Lane"
      },
      "details": {
        "vcse": false,
        "scale": "large"
      },
      "contactPoint": {
        "email": "patrick@scarlet.cc"
      }
    }
  ],
  "language": "en",
  "contracts": [
    {
      "id": "1",
      "title": "Regulatory Compliance Services for Medical Devices",
      "value": {
        "amount": 75000,
        "currency": "GBP",
        "amountGross": 90000
      },
      "period": {
        "endDate": "2027-03-31T23:59:59+01:00",
        "startDate": "2026-06-02T00:00:00+01:00"
      },
      "status": "active",
      "awardID": "1",
      "documents": [
        {
          "id": "058183-2026",
          "url": "https://www.find-tender.service.gov.uk/Notice/058183-2026",
          "format": "text/html",
          "noticeType": "UK7",
          "description": "Contract details notice on Find a Tender",
          "documentType": "contractNotice",
          "datePublished": "2026-06-19T15:03:16+01:00"
        }
      ],
      "dateSigned": "2026-06-02T00:00:00+01:00",
      "aboveThreshold": false
    }
  ],
  "initiationType": "tender"
}