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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.

According to European Regulations on Medical Devices and in vitro diagnostic medical devices, manufacturers shall have available at least one person responsible for regulatory compliance who possess demonstrated expertise in the field of medical devices.
The Person Responsible for Regulatory Compliance (PRRC) shall be at least responsible for ensuring that:
a) Conformity of devices are appropriated with the relevant Quality Management System (QMS)
b) The technical documentation and EU DoC are up-to date
c) Post market surveillance obligations are properly performed
d) Reporting obligation on  serious incidents and field safety corrective actions are met

Manufacturers would be wise to hire this position with qualified professionals to:
1. Be compliant with the EU regulatory requirements
2. Ensure the safety and compliance of the marketed devices
3. Avoid any financial penalties or reputational harm
If you need a PRRC, contact us to know what Osmunda can do for you!  

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