Hologic, Inc. announced today that its Aptima® HPV Assay received an expanded CE-IVDR marking in the European Union and the ...

The UK government has launched a consultation asking whether medical devices with CE marks issued in the EU and sold in Great Britain should be recognised indefinitely. The Medicines and Healthcare ...

As previously announced, the UK government has enacted legislation to continue the recognition of the CE marking indefinitely for a range of products falling within the scope of 21 regulations, ...

This article will examine market access outside the EU/EEA based on reliance and recognition. For countries outside the European Union (EU) and European Economic Area (EEA), regulatory reliance and ...

New indication in the European Union and the UK offers alternative method of screening especially for women who are not currently participating Hologic, Inc. announced today that its Aptima HPV Assay ...

The UKCA mark was introduced in the Great British (GB) market to replace the European CE mark following Brexit. Products which require a CE mark in the EU must comply with the UKCA marking regime if ...