Did you miss the Webinar on EUDAMED MODULE 2? We got you covered!

November 23, 2021

WEBINAR | EUDAMED MODULE 2

Asphalion expert Fran Rodríguez unveils the new challenges EUDAMED Module 2 poses.

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NEW | IVDs Medical Devices Regulation

At European level, it has been considered necessary to establish a new solid, transparent, predictable and sustainable regulatory framework for in vitro diagnostic medical devices, that guarantees the highest level of safety and protection of patients and users health, and at the same time promotes innovation and the interests of small and medium-sized enterprises that carry out their activities in this sector.

WEBINAR RECORDING | Regulatory tips for Medical Device and IVD developers

Article 86 MDR requires manufacturers of Class IIa, Class IIb, and Class III devices to prepare a Periodic Safety Update Report (PSUR) for each device and, when relevant, for each category or group of devices. The MDCG 2022-21 guideline endorsed by the Medical Device Coordination Group (MDCG) provides ideas for manufacturers on how to prepare the PSUR for their Medical Devices.

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