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In accordance with §103 of the MDR, the Medical Device Coordination Group (MDCG) has been established. The MDCG and its sub-groups publish guidances that provide clarification and support to national competent authorities, notified bodies and economic operators on the details of the implementation of the MDR and IVDR. The members of the MDCG ...
Additionally, the EU member state accrediting the notified body will then inform the European Commission that the product complies with the essential requirements (or not). [1] [2] [3] More generally, a notified body is an independent, accredited body which is entitled by an authorized accrediting body. Upon definition of standards and ...
Regulation (EU) 2017/746 (IVDR) is a regulation of the European Union on the placing on the market and putting into service of in vitro diagnostic medical devices (IVD), repealing Directive 98/79/EC (IVDD), which also concerned IVD. The regulation was published in April 2017 and is closely aligned to the EU regulation on medical devices.
English: These Regulations contain the legislative measures necessary for the implementation of three European Community Directives- Council Directive 90-385-EEC on the approximation of the laws of the Member States relating to active implantable medical devices, as amended; Council Directive 93-42-EEC concerning medical devices, as amended; and Directive 98-79-EC of the European Parliament ...
Oversee the Notified Bodies that ensure medical device manufacturers comply with regulatory requirements before putting devices on the market. Operate a quality surveillance system to sample and test medicines to address quality defects and to monitor the safety and quality of unlicensed products.
EU countries that permit the reprocessing of single-use devices may maintain or introduce national rules under Article 17(9) of MDR that are stricter than those laid down in the MDR. These national rules have to be notified to the Commission. [62] Some EU countries do permit regulated reprocessing. Germany is one such example.
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Substance-based medical devices encompass a varied array of products that fall under the purview of Regulation (EU) 2017/745 (MDR). Based on their intended purpose, they are classified according to rule 21 ("Devices composed of substances that are introduced via a body orifice or applied to the skin") of Annex VIII of the MDR . [2]