Pipeline Framework: Notified Body and ISO 13485 certificating body

A pipeline has been launched for Notified Body and ISO 13485 certificating body.The contract start Date is 01 August 2018. Approach to market date is 07 May 2018.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 (nawaz.habib@nibsc.org) by close of play 24 April 2018.This is a potential opportunity from the government, and the pipeline gives advance notice of an opportunity that might be offered by the public sector in the future – allowing potential suppliers to plan accordingly. When a public sector organisation publishes a pipeline notice, it does not necessarily mean that an opportunity will be offered in the future.For more information contact: Medicines and Healthcare Products Regulatory Agency, NIBSC, Blanche Lane, South Mimms, Potters Bar, Hertfordshire, EN63QG, England. Telephone: 01707641212. Email: nawaz.habib@nibsc.org. (Nawaz Habib)