On 3 April 2020, the European Commission issued a guidance on medical devices, active implantable medical devices and in vitro diagnostic medical devices ("IVD") in the COVID-19 context....more
The Belgian federal agency for medicines and health products (AFMPS or FAGG) provides that Belgium acts as a logistical platform for certain medicinal products....more
The European Commission today announced that it is preparing a proposal to postpone the entry into application of the new Medical Devices Regulation (MDR). The proposed postponement would be for one year....more
On 16 March 2020, the European Commission published Recommendation (EU) 2020/403 of 13 March on conformity assessment and market surveillance procedures within the context of the COVID-19 threat. The objective of the...more
On 1 February 2019, the European Commission published a new Q&A document to give further guidance on the Notice to stakeholders-withdrawal of the United Kingdom and EU rules in the field of industrial products (“the Notice”)....more
2/14/2019
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UK Brexit
On 20 November 2018, the European Commission published nine new documents intended to provide guidance to non-EU authorities and economic operators in relation to the Medical Devices Regulation (“MDR”) and In vitro Diagnostic...more
The European Commission just published an “implementing measures rolling plan” in relation to the MDR and IVDR which are scheduled to apply from 26 May 2020 and 26 May 2022 respectively....more