The European Commission (EC) has published a Commission Implementing Decision requesting a review (standardisation) of a set of existing standards, as well as new standards to be drafted, for support of Regulations 2017/745 (MDR) and 2017/746 (IVDR). https://ec.europa.eu/growth/tools-databases/mandates/index.cfm?fuseaction=search.detail&id=589#
Asphalion closely follows news and movements around the new MDR and IVDR to better assess manufacturers and stakeholders on their implementation. If you have questions on MDR implementation do not hesitate in contacting us at [email protected].