On 6 January 2023, the European Commission published a proposal to amend the Medical Device Regulation (MDR) and the In Vitro Diagnostic Medical Device Regulation (IVDR) to reduce the risk of shortages. Today, 16 February 2023, the European Parliament has voted positively with overwhelming majority on the draft. As Council agreed already in late January, the amendment is de facto accepted. The Notified Body TÜV SÜD Product Service GmbH welcomes the amendment in the interest of patient safety and continues to call on manufacturers to act promptly.
In principle, manufacturers will now be given more time to bring existing products
In principle, manufacturers will now be given more time to bring existing products
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