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Hogan Lovells Publications

European Investigations Guide 2020

Multinationals face a variety of questions when confronted with an internal investigation. Especially in Europe, cross-border investigations can be challenging to navigate as every...

News

Belgium temporarily bans the making available and use of rapid COVID-19 IVD self-tests

The Belgian competent authority (FAGG/AFMPS) has banned the supply and use of rapid diagnostic self-tests for the coronavirus (COVID-19) for six months. The purpose of the ban is to avoid...

News

The European Commission has published Guidelines concerning the use of phthalates in medical devices

The European Commission’s Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) has published Guidelines concerning the use of phthalates in medical devices.

News

European Commission draft implementing regulation on the reprocessing of single-use medical devices

On 23 July 2019, the European Commission published the draft Commission Implementing Regulation (hereafter “Draft”) regarding Common Specifications for the reprocessing of...

News

European commission publishes additional Guidance regarding the Medical Devices vigilance system

The three medical devices Directives, the Directive for Active Implantable Medical Devices (AIMD), the Directive for Medical Devices (MDD) and the In Vitro Diagnostic Medical Devices...

News

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. The Royal Decree forms part...

News

European Commission publishes factsheet on the (in vitro) medical devices procurement ecosystem

The European Commission has published a factsheet addressed to organisers of public tenders involving medical devices. The goal of the factsheet is to provide hospitals, clinics, ministries ...

News

European Commission factsheet on medical devices and IVDs for non-EEA competent authorities

The European Commission has published a factsheet addressed to competent authorities of third countries. This factsheet is one of several guidance documents published by the European...

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