UK designated standards
Eamonn Hoxey
Retired from technical writing, training and consulting - quality & regulatory compliance, sterility assurance, standards development
It is important to be aware that the MDR and IVDR will not be implemented in England, Scotland and Wales. In this context, the distinction between Great Britain (GB) – England, Scotland and Wales – and the United Kingdom, which comprises Great Britain and Northern Ireland, is relevant. Northern Ireland will have a special status as EU rules will continue to apply there. The Northern Ireland Protocol is a key part of the agreement on the UK withdrawal from the European Union. The effect of the Northern Ireland Protocol is that products on the Northern Ireland market, including medical devices, are required to comply with EU Regulations and Directives as well as with UK law. Separate requirements regarding CE marking will apply in Northern Ireland.
This blog post is an excerpt from BSI's latest whitepaper:?Using Standards to Demonstrate Conformity. Please download the full whitepaper to find out more information.