FREE WEBINAR | Regulatory tips for Medical Device and IVD developers

February 2, 2023

MedTech entrepreneurs, developers and manufacturers play an important role in public health and the global economy. The medical device industry is one of the most regulated industries; it is regulated and enforced by law to ensure safety, performance and efficacy of devices during their lifetime, from their pre- and post-market lifecycle.

In the current rapidly evolving regulatory environment entrepreneurs, developers and manufacturers are requested to consider and include regulatory aspects as early as possible to optimize resources and avoid re-engineering.

Adi Ickowicz, Senior Principal at Asphalion, will deliver this webinar. The purpose is to provide tips and essential information to medical device and IVD entrepreneurs, developers and manufacturers. During the webinar, principles on regulatory affairs will be discussed. There will be some time for Q&A afterwards. You can send your questions in advance or on the same day.

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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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