#UPDATE PROGRAM SERIES| “Challenges for Medical Device manufacturers in 2021”
2021 will bring new challenges for Medical Device stakeholders: EUDAMED’s modules, new MDR requirements as of May 26th, 2021, as well as Brexit, that will bring challenges of its own.
Asphalion’s team of Medical Device experts has organized a program consisting of 2 free online Q&A sessions with the latest updates:
1st SESSION | 15th February 2 p.m. CET. EUDAMED and its impact on its main stakeholders
The European Commission made available on December 1st, 2020 the EUDAMED Actor registration module to Member States and economic operators. Through this Module, all Medical Device economic operators must submit an Actor Registration request containing the information necessary to obtain their single registration number (SRN).
Join our online session to learn more about EUDAMED and the impact on its main stakeholders. Asphalion’s Medical Device expert team will hold this webinar aimed to inform you about the effect of this regulation.
2nd SESSION | 15th February 3 p.m. CET . Brexit, what is new for Medical Device Manufacturers?
Did you know that from January 2021, Medical Device Manufacturers may approach UK Approved Bodies (UKAB) and submit their devices to a UK Conformity Assessment procedure (UKCA)?
Brexit brings additional procedures for placing your devices in the UK market.
Join our online session to learn more about BREXIT and the impact on its manufacturers. Asphalion’s Medical Device expert team will hold this webinar aimed to inform you about the effects of this transition in the UK market.
