Surgical Implants for Men’s and Women’s Health

Concepts

• surgical implants
• breast implants
• nipple implants
• gluteal implants
• facial implants
• chest implants
• testicular implants
• penile implants
• implants
• £15,000 - facial implants

Location

United Kingdom: Various Locations in the UK

Description

The Framework Agreement will look to include the following range of products - Breast Implants including Sizers and Expanders, Nipple Implants, Calf and Gluteal Implants, Facial Implants, Chest Implants, Testicular Implants, Penile Implants. The precise quantities of the products that will be required by NHS Supply Chain under the terms of this Framework Agreement are unknown at the date of this notice. It is anticipated that initial expenditure will be in the region of £2,000,000 to £2,500,000.00: - Breast Implants including Nipple Implants, Sizers and Expanders in the region of £2,250,000; - Calf and Gluteal Implants in the region of £0 to £15,000 - Facial Implants in the region of £0 to £10,000 - Chest Implants in the region of £0 to £25,000 - Testicular Implants in the region of £0 to £75,000 - Penile Implants in the region of £0 to £125,000 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. The estimated value over the total Framework Agreement term (including any extension options) will be in the region of £8,000,000 to £10,000,000 excluding VAT.

Total Quantity or Scope

Should include but not limited to: Breast Implants including Nipple Implants, Sizers and Expanders; Calf and Gluteal Implants; Facial Implants; Chest Implants; Testicular Implants; Penile Implants. Additional information: Precise quantities are unknown. It is anticipated that initial expenditure will be in the region of £ 2,000,000 to £ 2,500,000 in the 1first 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.

CPV Codes

• 33184100 - Surgical implants
• 33184410 - Internal breast prostheses

Indicators

• Restrictions apply to the lot award allocation.

Other Information

PLEASE NOTE: The proposed lotting structure maybe subject to change, however the scope of the product range for this framework will remain the same. 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. ** PREVIEW NOTICE, please check Find a Tender for full details. ** The purpose of this notice is to draw attention to a procurement that NHS Supply Chain intends to commence during the subsequent 12 months. The invitation to tender will be the subject of a separate notice and it is that notice to which potential suppliers will need to respond at the appropriate time. 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. 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: - Cyber Essentials Plus Certificate or completion of an (ISTP) Questionnaire. - ISO 9001: 2015 accredited by the United Kingdom Accreditation Service (or equivalent) to cover all segments of the Applicant’s and the product’s supply chain. This should include, but not be limited to, manufacturing, storage and distribution. If Quality Assurance Standard 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. - Declaration of Conformity and UKCA Certification to demonstrate compliance to UK Medical Device Regulations 2002 or Declaration of Conformity and CE Certification 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) to demonstrate compliance to Medical Devices Directive 93/42/EEC or Medical Device Regulation 2017/745 (where applicable). - MHRA registration of any medical devices, in compliance with the Medical Devices Regulations 2022 (SI 2022 No 618, as amended) (UK MDR 2022). - The Insurance set out below, acceptable evidence of which should be an Insurance Certificate or a signed Broker’s letter. > 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 per claim and in the annual aggregate > Professional Indemnity Insurance cover of £5m in the name of the Applicant NHS Supply Chain will assess the Applicant’s economic and financial standing (or that of the entity or entities the Applicant is relying upon). Documentary evidence of this will be required at tender stage. All Applicants for this future tender must have a compliant Carbon Reduction Plan to be considered for the Framework Agreement (PPN 06/21). This future Framework Agreement will include some qualitative evaluation questions on Social Value with a minimum weighting of 10% towards the award (PPN 06/20). All Applicants bidding to be on any NHS Supply Chain Frameworks must submit an Evergreen Assessment as part of the tendering process. This must be completed annually, and the maturity score will be valid for 12 months. https://www.england.nhs.uk/nhs-commercial/central-commercial-function-ccf/evergr... As a minimum (and further requirements may be set out in the tender documents), Applicants are required to have a Modern Slavery Assessment (MSAT) completed within 12 months of the future tender close date (PPN 02/23). 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.