On Monday and Tuesday, Lidia Cánovas, General Manager & Regulatory Affairs Director at Asphalion, and Dominique Monferrer, Scientific & Regulatory Affairs Associate Director at Asphalion, participated in the MedTech Summit 2019.
This conference took place in Brussels and provided us an updated on the most recent changes in medical devices (MD) and In vitro diagnostic medical devices (IVDR) european regulation. The new regulation for MD (MDR – Medical Device Regulation (EU) 2017/745) will become fully applicable in May 2020 and Asphalion closely follows news and movements from key stakeholders around the new MDR and IVDR to better assess manufacturers on their implementation.
If you need some help to review the compliance with the requirements of the new MDR, contact us: [email protected]