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New medical device regulations: what liability do notified bodies face?
  • Hogan Lovells
  • European Union, Italy
  • February 13 2019

Under the EU Medical Device Regulation and the EU In Vitro Diagnostic Medical Device Regulation, organisations that want be recognised as notified


Would you like an extra application with that? FDA mulls requiring dual applications for combination products
  • Hogan Lovells
  • USA
  • February 8 2019

On Tuesday, FDA announced the availability of a draft guidance, “Principles of Premarket Pathways for Combination Products,” with high-level


BGH: Textilkennzeichnung Cotton“ statt Baumwolle“ nicht unlauter
  • Hogan Lovells
  • Germany
  • February 7 2019

Der BGH hat mit Urteil vom 31. Oktober 2018 (I ZR 7317) entschieden, dass die Benutzung der englischen Bezeichnung Cotton“ statt Baumwolle“ zur


New Belgian legislation on the distribution of medical devices
  • Hogan Lovells
  • 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


Doing business in the United States - U.S. Consumer sector 2019
  • Hogan Lovells
  • USA
  • January 25 2019

The United States has the most well-developed consumer economy in the world, with approximately US$13.2 trillion in annual consumer spending, the


In the midst of government shutdown, FDA pushes ahead with 510(k) modernization
  • Hogan Lovells
  • USA
  • January 24 2019

Thirty-two days into the longest government shutdown in U.S. history, the Food and Drug Administration (FDA or the agency) announced two developments


OLG Stuttgart: Unlauterkeit bei englischsprachiger Angabe von Textilkomponenten
  • Hogan Lovells
  • Germany
  • January 24 2019

Mit Urteil vom 18. Oktober 2018 (2 U 5518) hat das OLG Stuttgart klargestellt, dass Komponenten eines Textilerzeugnisses nach der Verordnung Nr


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


10 key changes to UK product safety laws?
  • Hogan Lovells
  • United Kingdom, European Union
  • January 17 2019

Given developments this week, Brexit remains top of the agenda. While the UK government doesn't have the same level of "shut down" as the US


Der (Gesundheits-)Polizei kann geholfen werden - LemonAid -
  • Hogan Lovells
  • Germany
  • January 14 2019

Weil sie nicht den Mindestzuckergehalt der Leitsätze für Erfrischungsgetränke erfüllt, sollte die Lemonaid-Limonade ihren Namen verlieren. Das