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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

European Union to introduce a transferable exclusivity voucher to incentivize the development of new antimicrobials

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

European Commission proposes to extend MDR transition periods to prevent shortages in medical devices

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

European Commission unveils surprise amendment to In Vitro Diagnostics Regulation

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

EC consults on revision to pharmaceutical legislation

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

EU Clinical Trial Regulation to Take Effect on 31 January 2022

The European Commission has announced that the Clinical Trials Regulation, already enacted in 2014, will take effect on 31 January 2022....more

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