Hamburg, 11th August 2020, Christoph Petershagen
On 07/08/2020, the European Union has released the “Commission guidance for the medical devices expert panels on the consistent interpretation of the decision criteria in the clinical evaluation consultation procedure” (2020/C259/02) in the official journal of the European Union, which was announced already in article 106 of Regulation (EU) 2017/745 on medical devices.
The focus of this document is to provide guidance for the expert panels required for the consultation procedure, however, it contains relevant information for manufacturers as well. In particular, the document outlines defined criteria for “novel features” for the first time. This definition is relevant for every manufacturers’ technical documentation, since the regulation requires to name novel features in the documentation in Annex II section 1.2. At the same time the guidance will help manufacturers to understand which changes and new developments might require a consultation procedure acc. to article 54 which should be considered in the manufacturers project planning.