MDR: Harmonised standards for QMS and risk management

Since May 26, 2021, the medical device sector experienced a great change. The new Regulation replaced the previous Directive and from that date, manufacturers of medical devices have to comply with the new Regulation, either fully or with certain provisions only (legacy devices). With the new Regulation, the European Commission also published harmonised standards in support of MDR.
Assessment of new standards
On May 17, 2022, the Commission implementing Decision on harmonised standards for quality management systems and for application of risk management of medical devices was Oh! It looks like you do not have access to this page.
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