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Blog 12/01/2022
On 20 December 2021, the European Commission reported that the In Vitro Diagnostic Medical Devices Regulation that will apply as from 26 May 2022, can be progressively rolled out, following its adoption by the European Parliament and Council, enabling the continued supply of essential in vitro diagnostic medical devices and the protection of public health and safety.
Blog 29/12/2021
On 2 September 2021, the EU issued their second recommendation under (EU) 2021/1433 on conformity assessment and market surveillance procedures for Personal Protective Equipment (PPE) in relation to the COVID-19 pandemic and in light of the exceptional situation caused by pandemic and the unprecedented levels of demand for PPE.
Blog 22/12/2021
A significant number of COVID-19 test products sold in the UK have failed to replicate their stated performance for their intended use and in real world use evaluation. On 2 September 2021 the UK Department for Health and Social Care opened a public consultation to introduce further scrutiny on COVID- 19 tests on the UK market under the Medicines and Medical Devices Act 2021.
