Medical equipments, pharmaceuticals and personal care products

Description

The Secretary of State for Health and Social Care acting through Public Health England (PHE) is seeking to appoint suppliers to a multi-lot national microbiology framework agreement. The framework agreement relates to the supply of diagnostics goods for the qualitative/quantitative examination of specimens/samples and the development or manufacturing of assays/kits/medication and related services. It also relates to the supply of diagnostics services for the qualitative/quantitative examination of specimens/samples or the development or manufacturing of assays/kits/medication. The framework also covers clinical laboratory diagnostic testing services. The term of the framework will be for an initial 2 years with options to extend by up to a further 2 years. Lot 1 is for the supply of in-vitro diagnostic medical devices and associated services including equipment, consumables, maintenance, and peripheral equipment and associated services. All goods supplied must comply with the European Directive 98/79/EC on In Vitro Diagnostic Medical Devices (IVDMD) (1998) or Regulation (EU) 2017/746 (IVDR) as applicable. All reagents and consumables must be marked in accordance with current CE regulations (or, once superseded, the UKCA mark). Lot 2 consists of goods and services mainly for research and development, experimentation and study. The supplies may form a part of the whole diagnostic product life cycle. Products and services do not need to be CE marked (or, once superseded, UKCA marked) as they are under development and primarily used for research and development. Lot 3 is for the manufacture of diagnostic and/or therapeutic products for the purpose of research, experimentation, study, development or to establish commercial viability or to recover research and development costs. Manufacturers must adhere to the relevant regulations for example for in vitro medical devices/medical devices, the current IVDD/MDD respectively and from May 2022 the new IVDR or from May 2021 the new MDR. The supplier may be required to discount or agree preferential terms for the products sold on the open market where the authority has given input into the development and validation of the product, including the sharing or use of the authority’s intellectual property. The supplier may be required to supply products, materials and other services related to the sale and/or distribution of the manufactured products. There may also be other commercial exploitation arrangements, which may include the licensing of the authority’s intellectual property in return for a license fee. Lot 4 is to provide access to a range of clinical laboratory diagnostic testing services. The exact specification for each requirement will be detailed in the call-off order form. The volumes of services contracted via this lot are expected to be scalable to meet evolving demand over time taking account of long term and short term (surge) requirements, combined with small-scale or large-scale service provisions being sought. Lot 4 is intended to enable access to clinical laboratory diagnostic testing services using extant techniques and allow for the addition of new techniques or existing techniques utilised in a new manner in the future. The aim for this lot is to ensure that there is consistent and affordable provision of high quality, safe and compliant testing services which should be delivered efficiently and effectively to support wider clinical services. With regards to the clinical laboratory diagnostic testing services to be offered through the framework the authority is seeking suppliers that can undertake the following types of testing: — molecular biology; and — microbiology including: • Bacteriology; • Virology; and • Serology. Suppliers will also be expected to provide all necessary supporting services including but not limited to the receipting of samples, storage, accessioning, laboratory informatics and clinical waste disposal. Where necessary it is also envisaged that suppliers may be required to provide their own sample kits and logistical services.