ISO 11737 2:2009, Sterilization Of Medical Devices ....pdf
ISO 11737-2:2009 specifies the general criteria for tests of sterility on medical devices that have been exposed to a treatment with the sterilizing agent reduced relative to that anticipated to be used in routine sterilization processing. These tests are intended to be performed when defining, validating or maintaining a sterilization process.
ISO 11737 2:2009, Sterilization of medical devices ....pdf
Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market
The MDR has entered in force on May 26 this year and on July 16th the European Commission published harmonized standards for medical devices (Commission Implementing Decision (EU) 2021/1182), to support the MDR. This Implementing Decision entered in force at the same date of its publication.
Implementation of the MDR is a top priority for the medical devices industry, which has committed significant resources to comply with the new requirements. Despite its efforts, the sector remains seriously held back by the slow and piecemeal implementation of the new regulatory framework.
On 5 of July of 2022, the European Commission published the implementing Regulation (EU) 2022/1107 of 4 July 2022 laying down common specifications for certain class D in vitro diagnostic medical devices in accordance with Regulation (EU) 2017/746.
EUDAMED is one of the key aspects of the new rules on medical devices (Regulation (EU) 2017/745) and in vitro diagnostic medical devices (Regulation (EU) 2017/746), and it is expected to achieve full functionality by the second quarter of 2024.