MedTech Europe and Mecomed Highlight MDR and IVDR Impact on International Registrations in MEA
MedTech Europe and Mecomed have published considerations on the impact of the EU MDR and IVDR transition on international registrations in the Middle East and Africa, calling for a harmonised and risk-based approach to change management.
IMDRF Publishes Final Document on Predetermined Change Control Plans for Medical Device Software
IMDRF has published final principles on Predetermined Change Control Plans for medical device software, covering PCCP elements, risk-based change control, impact assessment, benefits and challenges.
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Health Canada publishes new guidance on “significant change” for medical devices
Health Canada clarifies when medical device changes require licence amendments. Key insights for manufacturers on risk, software, and design changes.