Endoscopy, Endourology & Oncology Ablation Consumables and Associated Products

The framework agreement with cover Endoscopy, Endourology & Oncology Ablation Consumables and Associated Products. Precise quantities are unknown. It is anticipated that initial expenditure will be in the region of £100,000,000 to £105,000,000 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. An estimated annual value of £426,000,000 over a (2+2 year term). The Framework Agreement between NHS Supply Chain and successful suppliers will reserve the right to purchase the same or similar supplies and/or services from suppliers not appointed to the Framework Agreement at its sole discretion. NHS Supply Chain intends to enter into arrangements under which it will be entitled to purchase supplies and/or services which it will make available for purchase by 1) any NHS Trust; 2) any other NHS entity; 3) any government department, agency or other statutory body and/or 4) any private sector entity active in the UK healthcare sector. Only NHS Supply Chain can order from the Framework Agreement and enter into contracts under it. 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 £Xm per claim or £Xm 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).