Hélène Boland

Hogan Lovells

+ Follow Contact

Latest Posts › Regulatory Standards

Share:

European Commission announced its plan to postpone the implementation of the MDR by one year

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

3/30/2020 / EU , EU Directive , European Commission , Life Sciences , Medical Devices , Pharmaceutical Industry , Regulatory Oversight , Regulatory Standards , Rulemaking Process

New Belgian legislation on the distribution of medical devices

Today, the Belgian Minister of Health published the new Royal Decree of 19 December 2018 on the liberalisation of the distribution circuit for medical devices....more

1/28/2019 / Belgium , EU , EU Directive , Life Sciences , Medical Devices , New Legislation , Pharmaceutical Distribution , Pharmaceutical Industry , Regulatory Oversight , Regulatory Standards

The European Commission publishes nine new guidance documents in relation to the MDR and IVDR

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

11/26/2018 / EU , European Commission , Healthcare , Life Sciences , Medical Devices , New Guidance , Pharmaceutical Industry , Regulatory Oversight , Regulatory Standards

New “rolling plan” and new guidance documents in relation to the MDR and IVDR

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

10/22/2018 / EU , EU Directive , European Commission , Life Sciences , Medical Devices , New Guidance , Pharmaceutical Industry , Regulatory Oversight , Regulatory Standards

4 Results

View per page

Page: of 1