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
Following the election in February, the party leaderships of CDU, CSU and SPD have agreed on a coalition agreement titled “Responsibility for Germany”. The 146-page document also sets out aspects regarding the healthcare and...more
4/29/2025
/ Digital Health ,
Health Insurance ,
Healthcare ,
Healthcare Reform ,
Hospitals ,
Investment ,
Life Sciences ,
Medical Devices ,
Pharmaceutical Industry ,
Popular ,
Telemedicine
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
4/1/2025
/ Appeals ,
Court of Justice of the European Union (CJEU) ,
EU ,
Judicial Authority ,
Life Sciences ,
Manufacturers ,
Medical Devices ,
New Regulations ,
Pharmaceutical Industry ,
Regulatory Oversight ,
Regulatory Requirements
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
1/28/2025
/ Clinical Trials ,
Data Privacy ,
Digital Health ,
EU ,
Germany ,
Health Technology ,
Healthcare ,
Healthcare Reform ,
Life Sciences ,
Medical Devices ,
Medical Research ,
Pharmaceutical Industry ,
Regulatory Reform ,
Regulatory Requirements ,
Technology Sector
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
The European Union (EU) has just published its proposals to revise its general pharmaceutical legislation. One of the objectives of the revision is to reduce the regulatory burden on the pharmaceutical industry when seeking...more
On Thursday, the EU Parliament approved the European Commission’s proposal to extend the transition periods of the Medical Device Regulation (EU) 2017/745 (MDR). As the Council had already signalled its support, the proposal...more
The European Commissioner for Health and Food Safety, Stella Kyriakides, has proposed measures to extend the transition rules of Medical Device Regulation (EU) 2017/745 (MDR) at the Employment, Social Policy, Health and...more
The European Commission has responded to pressure from the medical devices industry and has proposed an amendment to the In Vitro Diagnostics Regulation (“IVDR”, Regulation 2017/746) to introduce amended transitional...more
The postponement of non-urgent medical procedures in the early days of the Covid-19 pandemic led to a lull in MedTech transaction activity in the first half of 2020 but makers of medical devices returned in force in the...more