Commission Implementing Decision C(2020) 2532

medical devices

Commission Implementing Decision C(2020) 2532

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 info@asphlaion.com.

New regulation to ease the renewal of the designation of NBs and prevent shortages of MDs in the EU
Asphalion is proud to be sponsor of the Online Strategy Meeting on CMC & Regulatory Affairs!