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Coronavirus – Medical devices and biocide – Europe

  • Europe
  • Coronavirus
  • Coronavirus - Country overview
  • Intellectual property
  • Life sciences

27-03-2020

While medical professionals everywhere around the globe are working as hard as they can, both them as well as consumers are trying to get protective products to remain healthy and, where possible, prevent being contaminated. It is clear that in several countries all kind of medical devices, vitamin C’s, disinfecting products etc. are hard to come by. Production and sale should be expanded and obviously this poses opportunities for businesses. Daily, new measures are taken by the relevant authorities to ensure that the safe import, production and sale of such products can be up scaled in a safe and controlled manner.

In light thereof, the European Commission has announced on 26th March that it will put forward a proposal for the new Medical Devices Regulation, which should have entered into force on 26th of May this year, to postpone the implementation.

Similarly, the ECHA, the European Chemicals Agency, has called upon the national authorities to ensure for regulation which should make it possible for an increase in production of disinfectants. Fact is that the national legislation is still significantly varied and also temporary measure differ largely. What is more, for products such as disinfectants, face masks, vitamin C, etc. etc. the labelling of such products can cause the products to be regarded as a medical device, cosmetic, biocide or drug. It is therefore necessary to not just obtain the correct information about the (temporary) national regulations for the production and sale of such products, but also to obtain advice on the manner in which the product is marketed and do a check on the labelling, including the ingredients, claims, pictures etc.

The Life Science sector team of Eversheds Sutherland has the relevant up-to-date knowledge and the cross-border capability to advise you swiftly in such matters. Please feel free to reach out to Tobias Maier (co-head Life Science Sector), Elizabeth Graves (co-head Life Science Sector) or Thera Adam (co-head IP Global).

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