After the issue of implementing regulation for the reprocessing of single-use devices, EU Commission issued the implementing regulation 2022/2346 as regards common specifications (CS) for the groups of products without an intended medical purpose listed in Annex XVI of EU 2017/745 MDR.
The manufacturers who aim to produce the products covered by Annex XVI of MDR must comply with common specifications for the products covered by Annex XVI, the manufacturer need to demonstrate compliance with common specifications. Theses common specifications describe how these products can and should be assessed to demonstrate their safety and performance. The common specifications address the application of risk management and information for safety.
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