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European CE Marking

With a view to coordinating and standardizing the administration of medical devices in European countries, the EU has issued three Directives on three different categories of medical devices. Medical device manufacturers from all over the world must follow the afore-mentioned Directives if they want to place their products on the European market. In case that a domestic manufacturer intends to place its product on the EU market, the product shall be CE marked, which is a prerequisite for obtaining the qualification to export medical devices to the EU market.


These three Directives are: 1) Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices (AIMDD, 90/385/EEC); 2) Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (MDD, 93/42/EEC); and 3) Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices (IVDD, 98/79/EC). Among these three Directives, MDD (93/42/EEC) is the most widely used, covering almost all medical devices (such as medical materials and dressings, medical catheters, ventilators, all kinds of endoscopes and patient monitors, etc.)


On 5 May 2017, the EU published Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices (MDR, enter into force on 26 May 2017 and apply from 26 May 2020) and Regulation (EU) 2017/746 of the European Parliament and of the Council on in vitro diagnostic medical devices (IVDR, enter into force on 26 May 2017 and apply from 26 May 2022) in the Official Journal of the European Union. MDR will replace Directive 93/42/EEC (MDD) and Directive 90/385/EEC (AIMDD) after the three-year transition period officially ended on 26 May 2020, and IVDR will replace Directive 98/79/EC (IVDD) after the five-year transition period officially ended on 26 May 2022.


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