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Blog 15 mar 2023
On 26 June 2022, the UK’s medical device regulator, the Medicines and Healthcare products Regulatory Agency (MHRA) published their response to the consultation on the “future regulation of medical devices in the UK”, which indicates future wide-reaching change for the UK medical devices regulatory regime going forward.
Blog 17 fev 2023
On 6 January 2023, the EU Commission published its draft legislative proposal to amend the transitional provisions in Regulation (EU) 2017/745 for medical devices (MDR) and Regulation (EU) 2017/746 (IVDR) for in vitro diagnostic medical devices.
Blog 22 abr 2022
Since the UK’s exit from the European Union, the Medicines and Healthcare products Regulatory Agency (MHRA) has provided guidance on the regulation of medical devices and the requirements for their entry into the UK market.
Blog 21 abr 2022
The long awaited regulation on Health Technology Assessment (HTA), adopted on 13 December 2021 and published in the EU Official Journal on 22 December 2021, is a deliverable of the EU Pharmaceutical Strategy that aims to revolutionise patient access to vital and innovative technologies.
Blog 12 jan 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 dez 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 dez 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.
