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EU restricts Chinese access to public procurement of medical devices

Last Friday, the European Commission announced its first International Procurement Instrument (IPI) measure, excluding “economic operators” from China from participation in EU public procurement procedures for medical devices...more

New CJEU ruling on the borderline between medicinal products and medical devices: Key takeaways

The boundary between medicinal products and medical devices remains a recurring issue for companies developing or marketing borderline products and courts, which has already been the subject of numerous decisions. Recently,...more

Key regulatory changes impacting the healthcare industry in the EU and Germany in 2025

The regulatory frameworks in the life sciences and healthcare sector keep evolving rapidly and dynamically. Several important legislative reforms have been adopted over the last years, which are set to impact players in the...more

Telemedicine software under scrutiny – German court classifies dermatology software as class IIa medical device under the MDR

Telemedicine is getting more and more relevant to the healthcare industry, offering unprecedented access to medical services and enhancing patient care. However, telemedicine software providers often struggle with the...more

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