Medical Device Regulation — Reference List for Class I Medical Device Manufacturers

Download: medical-device-regulation---reference-list-for-class-i-medical-device-manufacturers.pdf 294 KB

The HPRA’s Medical Devices department has developed an introductory reference list for Class I medical device manufacturers, which is available to download using the above link. From 26 May 2021, Regulation (EU) 2017/745 on Medical Devices (MDR) will become fully applicable and manufacturers will be required to comply with the regulations in their entirety.

Although not an exhaustive list, this introductory list aims to help Class I manufacturers plan and co-ordinate their regulatory activities, helping ensure compliance in advance of May 2021.

The Medical Devices section of the HPRA website contains further guidance and helpful resources.

« Back