2020-8-7 · procedure packs June 2020 This document has been endorsed by the Medical Device Coordination Group (MDCG) established by Article 103 of Regulation (EU) 2017/745. The MDCG is composed of representatives of all Member States and it is chaired by a representative of the European Commission.
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Commission to invest €11 billion in new solutions for societal challenges and drive innovation-led sustainable growth. The European Commission today announced how it will spend the last and biggest annual tranche - €11 billion - of the EU research and innovation funding programme Horizon 2020 in …
Harmonised Standards. A harmonised standard is a European standard developed by a recognised European Standards Organisation: CEN, CENELEC, or ETSI. It is created following a request from the European Commission to one of these organisations. Manufacturers, other economic operators, or conformity assessment bodies can use harmonised standards ...
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Combination packs would only be acceptable in very exceptional cases, when there would be clear public health benefits for the treatment regimen and/or compliance, taking into account the required justifications set-out in section 4.1 of this guideline. Applicants are therefore advised to consult with