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Published 24 Apr 2018

Notified Body and ISO 13485 certificating body

Medicines and Healthcare products Regulatory Agency · United Kingdom

Key facts

Estimated value
£120,000
Contract starts
31 Jul 2018
Contract ends
31 Jul 2021
Procedure
Open procedure (above threshold)
Buyer type
Central government

Description

The National Institute for Biological Standards and Control (NIBSC) is a multi-disciplinary scientific establishment whose purpose is to safeguard and enhance public health by standardising and controlling biological substances used in medicines. One of its key roles is the production of reference materials including in vitro diagnostic devices (IVDs) and we are preparing to tender for a new Notified Body and ISO 13485:2016 certification body. We currently have 45 staff that are involved in the design and manufacture of 91 IVD products of which, 44 are currently Annex II List A and List B, and 47 are currently self-certified.

We are holding a supplier open day event on 27th April 2018 from 10:30 am to 12:30 pm. If you want to attend and/or need further details about this event, please send an email to provided email address ([email protected]) by close of play 24 April 2018.

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