MEDICAL TECHNOLOLGY (MEDTECH) INNOVATION DPS

Description

Supply Chain Coordination Ltd (the “authority or NHS Supply Chain”) is issuing this Invitation to Tender (“ITT”) in to establishing Dynamic Purchasing System (DPS). Offer a route to market for Innovative products (Novel or iterative and meets an unmet need or provides improvements upon existing models of care with the end-goal of benefiting the system, patients and/or care providers) The objectives of this contract are to: Enable customer access to Medical Technology (MedTech) products and associated services that would not normally be available and that are of an innovative nature that they cannot be range extended on to a traditional Framework Agreements. Provide a compliant route to the NHS market for innovative and game changing MedTech products, reducing the barriers to entry and the time to market. Whilst still maintaining patient safety and improving patient care. Enable early access to innovative technology and regulatory approved products which enhance treatment solution for NHS patients. Maintain a compliant route to market for the Trusts bringing innovation products to the market sooner. Improve patient outcomes. Category area covered by this DPS: - Orthopaedics, Trauma and Spine - Ophthalmology - Audiology - Cardiology - Endourology - Endoscopy - Neuromodulation - Oncology Ablation - Minimally Invasive Surgery - IVDR products/ tests (Pathology and Point of Care) Lot 1: There are criteria detailed within the tenders documentation around Compliance/Validation stage that is required to participate within this Innovation MedTech DPs that are a Pass/Fail Requirements. - URN Reference number provided by NHS Innovation service portal, HIN health innovation network or NHS SC Innovation Team where applicable for the following: - Innovation Service OR - National policy from NHSE or DHSC OR - NICE Guidance AND - MHRA Product Registration The following certification will be a requirement of the upcoming tender exercise and Applicants will be required to include evidence of this within their tender submission. - ISO 9001:2015 or equivalent externally accredited and up-to-date quality standard certificate(s) to cover all segments of the Applicant's (and the product's) supply chain. This should include but not be limited to manufacturing, storage, distribution and customer service. Further information in respect of certification requirements will be set out in the notice for the forthcoming procurement. If such certificates are not in the name of the Applicant then the Applicant must supply a copy of agreements setting out the authority and responsibilities of all parties in the supply chain and provide evidence of ISO9001:2015 or equivalent for all relevant parties in the supply chain. - Employers Liability Insurance cover of £5m per claim in the name of the Applicant - Public Liability Insurance cover of £5m per claim in the name of the Applicant - Product Liability Insurance cover in the name of the Applicant of £5m per claim or £5m in the annual aggregate - Declaration of Conformity and UKCA Certification to demonstrate compliance to UK Medical Device Regulations 2002 or Declaration of Conformity and CE Certification to d-Declaration of Conformity and UKCA Certification to demonstrate compliance to UK Medical Device Regulations 2002 or Declaration of Conformity and CE Certification to demonstrate compliance to Medical Devices Directive 93/42/EEC or Medical Device Regulation 2017/745 (where applicable). The NHS has adopted PPN 06/20 (taking account of Social Value), and therefore this future DPS Agreement will include some qualitative evaluation questions on Social Value with a pass/Fail requirement. For more information please see: https://www.gov.uk/government/publications/procurement-policy-note-0620-taking-account-of-social-value-in-the-award-of-central-government-contracts. In addition, from April 2023: the NHS adopted the Government’s ‘Taking Account of Carbon Reduction Plans‘(PPN 06/21) requiring all suppliers with new contracts for goods, services, and/or works with an anticipated contract value above £5 million per annum, to publish a carbon reduction plan for their direct emissions. From April 2024, the NHS will expand this requirement for all new contracts, irrespective of value. Suppliers bidding on NHS Supply Chain tenders will also be required to submit an Evergreen Assessment, please see https://www.england.nhs.uk/nhs-commercial/central-commercial-function-ccf/evergreen/. PPN02/23 "Tackling Modern Slavery in Government Supply Chains" will also apply.