BSI’s role as an EU Medical Devices Notified Body
BSI’s role as an EU Notified Body will not change following the recent decision of the EU referendum while the UK Government sets out the arrangements for its withdrawal from the EU. During this transition period, BSI will be working closely with the Medicines and Healthcare products Regulatory Agency (MHRA) to enable BSI to continue being recognized as a Notified Body for Medical Devices.
BSI fully anticipates we will remain a long term major EU Medical Device Notified Body as there are established well recognized existing mechanisms in place for non-EU countries to participate as EU Notified Bodies. For example, the designated organizations in Norway (under EEA recognition), Switzerland and Australia (through Mutual Recognition Agreements) are recognized as Notified Bodies for the purposes of the relevant EU legislation.
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We will continue to keep you updated on a regular basis as the political situation develops and discussions progress. For now, it’s business as usual and most importantly, we would like to assure you that BSI will continue to provide EU market access as we have done since the inception of the three EU Medical Device Directives.
All management systems, training and accredited certification remains unaffected by the outcome of the referendum.