- Country: United Kingdom
- Summary: Uk Approved Body for in Vitro Diagnostic (Ivd) Devices
- GBT Ref No: 92860677
- Deadline: 10 Jan 2024
- Financier: Self Financed
- Purchaser Ownership: Government
- Tender Value: Refer Document
- Notice Type: Tender
- Document Ref. No.: NOV458839
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- Description:
- The Medicines and Healthcare products Regulatory Agency requires a UK Approved Body that is capable of certifying IVD devices produced by Scientific Research and Innovation that are placed on the GB market.
Title: UK Approved Body for In Vitro Diagnostic (IVD) Devices
OCID: ocds-h6vhtk-041d1b
Published by: MHRA/ NIBSC
Authority ID: AA82595
Publication Date: 28/11/2023
Deadline Date: 10/01/2024
Deadline Time: 12:00
Notice Type: Contract Notice
Has Documents: No
Has SPD: No
Abstract: Scientific Research and Innovation (SR&I) (previously known as NIBSC) is placing In Vitro Diagnostic (IVD) devices on the GB market under EU IVD Directive 98/79/EC using EU Notified Body that issues CE certificates that are currently recognised on the GB market. Since 1 January 2021, there have been a number of changes to Medical Devices Regulations 2002, introduced through secondary legislation - Amendment of the Medical Devices (Amendment etc.) (EU Exit) Regulations 2019, to how medical devices, including IVD devices, are placed on the market in Great Britain (England, Wales and Scotland).Due to the changes, SR&I must appoint a UK Approved Body that can certify all Annex II List A and B IVD devices produced by SR&I that are placed on the GB market. This appointment will allow SR&I to continue placing IVD devices on the GB market after transition deadlines and support NHS and NHSBT laboratories and other diagnostic laboratories in safeguar... - Documents:
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CLICK HERE TO LOGINUk Approved Body for in Vitro Diagnostic (Ivd) Devices - Greatbritain Tender
The MHRA/ NIBSC, a Government sector organization in United Kingdom, has announced a new tender for Uk Approved Body for in Vitro Diagnostic (Ivd) Devices. This tender is published on GreatbritainTenders under GBT Ref No: 92860677 and is categorized as a Tender. Interested and eligible suppliers are invited to participate by reviewing the tender documents and submitting their bids before the deadline on 2024-01-10.
The estimated tender value is Refer Document, and full details, including technical specifications and submission requirements, are provided in the official tender documents. Ensure all submissions meet the criteria outlined to be considered for evaluation.
