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HPRA Issue Guidance on Distribution of Medical Devices

 

The New Medical Device Regulations entered into force on 25 May 2017. The Regulations have a staggered transitional period. The obligations for distributors will apply with the full application of the Medical Device Regulation (MDR) after three years (May 2020) and in vitro diagnostic medical devices (IVDR) after five years (May 2022).  Distributors should ensure compliance with the requirements and may use this Guidance as a support. If your organisation needs any assistance or training, contact us on info@gmp.ie