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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.
Directive 98/27/EC on injunctions for the protection of consumers' interests, repealed by Directive 2009/22/EC of the European Parliament and of the Council of 23 April 2009 on injunctions for the protection of consumers' interests. [6] Directive on alternative consumer dispute resolution, Directive 2013/11/ΕU, issued on 21 May 2013. [7]
Directive 98/71/EC of the European Parliament and of the Council of 13 October 1998 on the legal protection of designs is a European Union directive in the field of industrial design rights, made under the internal market provisions of the Treaty of Rome. It sets harmonised standards for eligibility and protection of most types of registered design
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 ...
The Annex ZC harmonized ISO 14971:2012 with the In-vitro Diagnostic Medical Device Directive 98/79/EC of 1998. [10] The 2021 addendum to ISO 14971 (ISO 14971:2019+A11:2021) was published to harmonize ISO 14971 and two European Regulations associated with medical devices through the two 'Zed' Annexes (ZA & ZB).
Directive 2003/98/EC on the re-use of public sector information, known as the PSI Directive, [2] [3] now called the Open Data Directive, [4] is an EU directive that stipulates minimum requirements for EU member states regarding making public sector information available for re-use. This directive provides a common legislative framework for this
Directive 2014/90/EU repealed Directive 96/98/EC on 18 September 2016. [2] EU Regulation 2024/1975 of 19 July 2024 layed down the rules for the application of Directive 2014/90/EU of the European Parliament and of the Council, as regards design, construction and performance requirements and testing standards for marine equipment and repealing ...
The Kingdom of the Netherlands brought Case C-377/98 [4] before the European Court of Justice against the adoption of the directive with six different pleas but the Court granted none of them. Nevertheless, the ECJ decision does not preclude a further test of the validity of the directive on the ground that it is inconsistent with the Agreement ...