Sinéad Cullen

William Fry


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Guidance Published on Appropriate Surveillance under Article 120 of the MDR

European Union, Ireland - April 28 2022 The Medical Device Coordination Group (MDCG) has published guidance on the activities to be performed by notified bodies as part of their ongoing…

Aisling Casey, Charleen O’Keeffe

European Commission Proposes a Unitary SPC and/or a Unified Procedure for Granting National SPCs

European Union - April 26 2022 The European Commission (EC) has proposed a Unitary SPC and/or a unified procedure for granting national Supplementary Protection Certificates (SPCs)…

Colette Brady, Charleen O’Keeffe, Laura Scott

Supreme Court Makes Preliminary Reference to the CJEU on the Validity of a Combination Product SPC

European Union, Ireland - April 22 2022 Merck Sharp & Dohme (MSD) brought an appeal to the Supreme Court (Court) following its unsuccessful appeal to the Court of Appeal against the High…

Colette Brady, Florence Meagher, Laura Scott

Progressive Roll Out of the IVDR Confirmed by EU Parliament and Council

European Union - January 7 2022 The In Vitro Medical Devices Regulation (Regulation (EU) 2017/746) (IVDR) sets out the new regulatory framework for in vitro diagnostic (IVD) medical…

Aisling Casey, Charleen O’Keeffe

New Medicines Supply Agreement Confirmed by IPHA

Ireland - December 20 2021 On 15 December, the Irish Pharmaceutical Healthcare Association (IPHA) announced a new four-year Framework Agreement on the Supply and Pricing of…

Colette Brady, Aisling Casey, Charleen O’Keeffe, Laura Scott