Structural Heart and VAD's

Concepts

• medical equipment
• artificial heart
• structural heart devices
• heart valves
• heart
• structural
• vad
• cardiovascular devices
• disposable non-chemical medical consumables
• balloon catheters

Location

Various Locations in the UK

Description

NHSSC seeks to establish a non-exclusive Framework Agreement (FAG) via the E-Direct and Direct Route for supply of Structural Heart Devices and Consumables. Products include Heart Valves, Annuloplasty rings and bands, and Ventricular Assisted Devices. Sutureless Valves are one of the high cost tariff excluded devices under the NHS England HCTED programme. NHS Supply Chain is the mandated route for the HCTED programme, and trusts who are commissioned to provide this service are directed to purchase all their requirements through NHS Supply Chain. Precise quantities are unknown. It is anticipated that initial expenditure will be in the region of £30,000,000 in the first year of this Framework Agreement, however this is approximate only and the values may vary depending on the requirements of those bodies purchasing under the Framework Agreement.

Lot Division

CPV Codes

• 33100000 - Medical equipments
• 33123000 - Cardiovascular devices
• 33141000 - Disposable non-chemical medical consumables and haematological consumables
• 33141210 - Balloon catheters
• 33141240 - Catheter accessories
• 33182000 - Cardiac support devices
• 33182220 - Cardiac valve
• 33182300 - Cardiac surgery devices
• 33184100 - Surgical implants
• 33184200 - Vascular prostheses
• 33184300 - Artificial parts of the heart
• 33184500 - Coronary endoprostheses
• 33190000 - Miscellaneous medical devices and products
• 33182200 - Cardiac stimulation devices
• 33182230 - Ventricle

Indicators

• Restrictions apply to the lot award allocation.

Other Information

The following certification will be a requirement of the upcoming tender exercise and Applicants may 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. - 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 per claim and 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). If an Applicant commits to obtain ISO9001:2015 or equivalent quality standard certificate, Public Liability Insurance or Product Liability Insurance certification at the time of their tender submission then the requirement is that such certification is in place prior to the commencement date of the framework agreement (in order for NHS Supply Chain to place orders with the successful Applicant). The NHS has adopted PPN 06/20 (taking account of Social Value), and therefore this future Framework Agreement will include some qualitative evaluation questions on Social Value with a min. weighting of 10% towards the award. For more information please see: https://www.gov.uk/government/publications/procurement-policy-note-0620-takingac.... 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/evergr.... PPN02/23 ""Tackling Modern Slavery in Government Supply Chains"" will also apply. As part of its pre-tender strategy, NHS Supply Chain would also like to engage with suppliers of these products via a Request for Information (RFI). If you would like to complete the Request for Information document in respect of the products which are the subject of this procurement then please follow the below instructions; REGISTRATION 1. Use URL https://nhssupplychain.app.jaggaer.com// to access the NHS Supply Chain Procurement portal. 2. If not yet registered: - Click on the ‘Not Registered Yet’ link to access the registration page. - Complete the registration pages as guided by the mini guide found on the landing page. PORTAL ACCESS If registration has been completed: - Login with URL https://nhssupplychain.app.jaggaer.com// . - Click on “SQs Open to All Suppliers”.