Common Specifications addressing Annex XVI Devices

In a significant development for the Medical Device Regulation (MDR) landscape, the adoption of the Common Specifications within the Commission Implementing Regulations 2022/2346 and 2022/2347 on 1st of December 2022 marks a pivotal milestone. These specifications establish a definitive basis for the conformity assessment procedure of Annex XVI devices, which have no medical purpose, and relevant documentation to be established by the manufacturers. Prior to this, no Common Specification had been fully enacted, leaving a void in the regulation of these products. This breakthrough finally fills that gap and provides a solid foundation for the evaluation of such devices, ensuring they meet the required safety and performance criteria. Additionally, these specifications bring with them reclassification of certain products, further aligning the regulation with the intended purpose of the devices.

Further information at ⁣Common Specifications addressing Annex XVI Devices (seleon.com)