Complete Audiological Products and Services 2027 PME

This framework will combine two current frameworks; ‘Hearing Aids, Hearing Aid Batteries, Custom Ear Moulds and Hearing Aid Accessories’ and ‘Audiological Diagnostics Implantable Devices and Services’ into the singular Complete Audiological Products and Services framework, which will include the CPV Classifications outlined below.

Certain products within this framework agreement are classified as high-cost tariff excluded devices under the NHS England Specialised Services Devices Programme (SSDP) (formerly known as the High-Cost Tariff-Excluded Devices programme). Trusts who are commissioned to provide specialised services in England are directed to purchase all their SSDP requirements through a national supply route via NHS Supply Chain.

Details of the product categories currently within scope of the NHS England Specialised Service Devices Page 6 to 15 Programme (SSDP), can be found using the following link: https://www.england.nhs.uk/commissioning/spec-services/key-docs/medical-devices/ In accordance with the specialised services commissioning policy, NHS Improvement and NHS England will determine which products are classified as excluded from tariff and which are made available under the NHS England Specialised Service Devices Programme (SSDP).

Whilst it is anticipated that initial expenditure under any forthcoming procurement will be in the region of 960,000,000 GBP, this is approximate only and the values will be to such level as those purchasing under the framework agreement consider necessary to provide suitable requirements. NHS Supply Chain expects to provide successful suppliers with the opportunity to offer additional savings to customers through the provision of discounted pricing, value added offerings and commitment/bulk buy initiatives. The framework agreement will be between NHS Supply Chain and the awarded supplier(s). Under the framework agreement there will be 2 different methods of supply — one for non-direct contract products and one for direct contract products.

For direct contract products the supplier will be required to report to and pay a direct contract management fee to NHS Supply Chain as detailed in the tender documents. NHS Supply Chain is currently considering the use of lots for this procurement. However, it reserves the right not to as part of any future tender process. Further information in respect of the lot strategy will be set out in the notice for the forthcoming procurement. As part of its pre-tender strategy, NHS Supply Chain would like to engage with suppliers of these products as detailed in Section 6, Engagement Process, below.

In order to participate on our tenders please see our key requirements below:

•ISO Certification: Tenderers must have ISO 9001: 2015 or BS EN ISO 13485:2016 or Medical Device Single Audit Program (MDAP) accredited by the United Kingdom Accreditation Service (or international equivalent) to cover all segments of the Tenderer's and the product's supply chain. This should include, but not be limited to, sales, manufacturing, storage and distribution ('ISO Certification')

Link for acceptable alternatives https://iaf.nu/en/accreditation-bodies/ ('Notified Bodies')

•CE Certification and Declaration of Conformity certificates are required where applicable to be presented at submission stage of the tender.

•Modern Slavery for Tenderers that have an annual turnover of at least £36 million must have a link to their modern slavery statement on their website

•Modern Slavery Assessment Tool (MSAT) Tenderers must have a score of 41% or above within 12months of the Tender Publication Date via https://supplierregistration.cabinetoffice.gov.uk/

•Evergreen Sustainable Supplier Assessment - Tenderers will need to have completed the assessment and achieved Level 1 within 12months of the Tender Publication Date. Link for instructions and access for this assessment: https://www.england.nhs.uk/nhs-commercial/central-commercial-function-ccf/evergreen/

•Carbon Reduction Plan (CRP): Tenders must have a valid CRP link on their website that meets the requirements of PPN 006 as outlined in the PPN, OR Where Supplier has no website, the CRP is provided in PDF format that meets the requirements of PPN 006 as outlined in the PPN, OR Excused in exceptional circumstances

•Cyber Security: If you handle patient or personal data, or provide any IT systems, services, or devices you will be need to have a Cyber Security Essentials Plus Certificate.

•Additional information- https://www.supplychain.nhs.uk/suppliers/useful-information