Surgical Mesh Fixation Devices

Concepts

• medical consumables
• surgical mesh fixation devices
• surgical mesh
• mesh fixation
• biologic mesh
• self-fixation mesh systems
• specialist mesh lot four
• synthetic mesh lot
• synthetic, biological and hybrid mesh
• mesh

Location

London

Description

This framework is for the supply of Surgical Mesh Fixation Devices. Surgical mesh is a woven sheet which is used as either a permanent or temporary support for organs and other tissues during surgery. The meshes are used in a variety of surgeries and reconstructive work including hernia and abdominal repairs, and reconstructive work such as breast reconstruction or pelvic organ prolapse. The framework includes most types of surgical mesh including synthetic, biological and hybrid mesh, and products which are used in conjunction with mesh fixation such as staples, glues and self-fixation mesh systems. The framework is made up of four Lots: Lot One: Synthetic Mesh Lot Two: Biologic Mesh Lot Three: Specialist Mesh Lot Four: Fixation Devices

Lot Division

CPV Codes

• 33140000 - Medical consumables

Indicators

• Restrictions apply to the lot award allocation.

Other Information

This PIN is intended to invite supplier engagement to further assist of the procurement and overall solution. It is anticipated that there will be supplier engagement which will cover the intended sourcing approach, regulatory compliance expectations within the ITT procedure. To register an expression of interest for this tender opportunity please register on the Jaggaer eProcurement Portal - https://nhssupplychain.app.jaggaer.com/ and express your interest in “SQ_458 - Expression Of Interest”. Expressions of interest for the supplier engagement must be received by 10:00BST on 22 Jan 2024. Further details regarding engagement will be shared in the new year. It is anticipated that the tender documents and Contract Notice will be published at the end of January 2024. It is intended that the Framework Agreement will be let for an initial term of 2 years, with optional extensions to not exceed a maximum 4 years overall. 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-taking-a.... 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.