Sinéad Cullen
William Fry
Articles
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…
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)…
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…
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…
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
