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AI in Medical Devices: Key Challenges and Global Responses

Ireland, USA - July 22 2021 The European Commission published its Proposal for a Regulation on Artificial Intelligence (AI) in April of this year. The Proposal set out plans for…

James Gallagher, Michaela Herron.

IVDR: Where Are We Now?

European Union, Ireland - July 22 2021 The In-Vitro Diagnostic Medical Device Regulation (EU) 2017/746 (IVDR) overhauls the existing regulatory regime provided for by the In Vitro…

Niall Collins, Michaela Herron.

The EU Digital COVID Certificate Regulation Comes into Effect

European Union, Ireland - July 21 2021 The EU Digital COVID Certificate has now been rolled out across Europe following a deadline of 1 July 2021 for Member States to adopt the technology…

Niall Collins, Saadi Siddiky.

New EU Guidance on Standardisation for Medical Device

European Union, Ireland - July 21 2021 The European Commission’s MDCG has issued new guidance explaining the role of standards in the medical devices sector (the Guidance). The Guidance…

Niall Collins.

Key Considerations in Pharma Licensing

Ireland - September 21 2020 Collaboration, whether in development or commercialisation, is a critical component in bringing new pharmaceutical or biotech products or devices to…