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Alexander Wenzel

Hogan Lovells


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New Belgian legislation on the distribution of medical devices

Belgium - January 28 2019 Today, the Belgian Minister of Health published the new Royal Decree of 19 December 2018 on the liberalisation of the distribution circuit for medical...

Hélène Boland, Fabien Roy.

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

European Union - January 25 2019 The European Commission has published a factsheet addressed to organisers of public tenders involving medical devices. The goal of the factsheet is to...

Elisabethann Wright.

The EMA has published a Concept paper for a Guideline for the development of medicinal products containing allergens to treat rare allergic diseases

European Union - January 23 2019 On 13 December 2018, the EMA published a “Concept paper on a Guideline for allergen products development in moderate to low-sized study populations”...

Elisabethann Wright.

European Commission publishes factsheet on medical devices and in vitro medical devices for non-EU and non-EEA competent authorities

European Union - January 8 2019 The European Commission has published a factsheet addressed to competent authorities of third countries. This factsheet is one of several guidance...

Elisabethann Wright.

The European Commission started implementing its “no-deal Brexit” Contingency Action Plan

United Kingdom, European Union - January 7 2019 On 19 December 2018, the European Commission published a Communication addressed at the EU institutions. The Communication relates to the preparation...

Elisabethann Wright.