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ETERNAL PROJECT | 6-month meeting

Collaborative project to boost reduction of the environmental impact of pharmaceutical products through their entire life cycle

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.


  March 22-24 | Congress Center, Basel Meet Asphalion’s team at DIA Europe, 2023!! The event will


By the numbers, there are currently 300 million people living with one of over 6,000 rare diseases worldwide. These affect between 3.5 and 5.9% of the population. 72% of rare diseases are genetic and 70% start in childhood. There is no cure for the majority of diseases and a few treatments available.

WEBINAR RECORDING | Regulatory tips for Medical Device and IVD developers

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.

MDR Transitional periods amendment

The European Parliament voted YES to MDR transitional provisions for certain medical devices and in vitro diagnostic medical devices.

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