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
Following a public consultation period this summer, the European Medicines Agency (EMA) published revised transparency rules (s. here) for the EU Clinical Trials Information System (CTIS) on 6 October 2023. The CTIS serves as...more
The European Commission (EC) has just published its draft proposals to overhaul the European Union (EU) general pharmaceutical legislation. Tackling the problem of antimicrobial resistance was a key priority in the 2020...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 Clinical Trial Regulation (EU) No 536/2014 (CTR) became fully applicable yesterday (31 January), following the end of the transition period. Therefore, the use of the Clinical Trial Information System (CTIS) is mandatory...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
On 19 September 2022, the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have published a joint statement confirming that biosimilars authorized in the EU are interchangeable. The EMA defines...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 European Commission has moved to the next phase in its evaluation of the current EU pharmaceutical legislation and the potential for its reform by opening a 12 week online public consultation....more
The European Commission has announced that the Clinical Trials Regulation, already enacted in 2014, will take effect on 31 January 2022....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
After weeks of tough wrangling, the Federal Cabinet has decided to oblige companies throughout Germany to offer coronavirus tests to their employees. This obligation will be included in the SARS-CoV-2 Occupational Health and...more