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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.
Under the General Product Safety Regulation (GPSR) — Regulation (EU) 2023/988 — products marketed in the EU must include an Authorized Representative if the manufacturer is located outside the European Union, starting from the 13th of December, 2024. This representative acts as a contact point for competent authorities in EU member states ...
Regulation (EU) 2017/745 is a regulation of the European Union on the clinical investigation and placing on the market of medical devices for human use. It repealed Directive 93/42/EEC on Medical Devices (MDD) and Directive 90/385/EEC on active implantable medical devices (AIMDD).
Download as PDF; Printable version; In other projects Wikidata item; ... (EU) 2017/745; Regulation (EU) 2017/746; Regulatory affairs; S. Substance-based medical ...
Regulation (EU) 2017/745; Regulation (EU) 2017/746; Regulation (EU) 2019/1020; Regulation (EU) 2023/988; Regulation (EU) No 1169/2011; Regulation of ESG rating in the European Union; Regulation of pesticides in the European Union; Regulation on Wholesale Energy Market Integrity and Transparency; Regulation to Prevent and Combat Child Sexual ...
Commission Implementing Regulation (EU) 2017/764 of 2 May 2017 approving non-minor amendments to the specification for a name entered in the register of traditional specialities guaranteed (Ovčí hrudkový syr — salašnícky (TSG)) Image title: Author: www.legislation.gov.uk: Software used: FOP 1.0: Conversion program: Apache FOP Version 2.1 ...
Commission Delegated Regulation (EU) 2017-1946 of 11 July 2017 supplementing Directives 2004-39-EC and 2014-65-EU of the European Parliament and of the Council with regard to regulatory technical standards for an exhaustive list of information to be included by proposed acquirers in the notification of a proposed acquisition of a qualifying holding in an investment firm (Text with EEA relevance)
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