What is Medical Device CE Marking and CE Certification?

In order for Medical Device Manufacturers to obtain the right to free movement in the European Market, it is necessary to demonstrate compliance with European Standards, in the simplest terms. This compliance is represented by the CE Marking/CE Certification process.

Before May 26, 2021, Medical Device Manufacturers followed the CE Marking/CE Certification processes based on the 93/42/EEC Medical Device Directive (MDD). However, as of May 26, 2021, the European Commission repealed the 93/42/EEC Medical Device Directive (MDD) and replaced it with the 2017/745/EEC Medical Device Regulation (MDR) for the CE certification processes of Medical Device Manufacturers.

The new Medical Device Regulation (MDR) establishes the rules for placing Medical Devices and Accessories on the European Union market and making them available, thus enabling free movement of products within EU countries. A thorough revision of the 93/42/EEC Medical Device Directive was necessary to ensure a higher level of safety and health for medical devices, and to create a transparent, traceable, and sustainable regulatory framework.

Key elements such as the supervision of Notified Bodies, conformity assessment procedures, Clinical Trials and Clinical Evaluation, Vigilance, Market Surveillance, and Inspection need to be significantly strengthened. Prior to MDR, implantable active medical devices and medical devices were regulated by two separate legal documents under the 90/385/EEC and 93/42/EEC Directives. For simplification, a single legislative measure was introduced for all medical devices, excluding In Vitro Diagnostic Medical Devices (IVD).

The scope of this Regulation should be clearly distinguished from other EU harmonization legislation related to In Vitro Diagnostic Medical Devices (IVD), Medicinal Products, Cosmetics, and Food, and should be exclusively dedicated to Medical Devices.

The Difference Between CE Marking and CE Certification

Under the 93/42/EEC Medical Device Directive (MDD), medical devices are classified into risk categories based on their intended use, locations of use, usage duration, and product content, with classifications such as Class I, Class Is, Class Im, Class IIa, Class IIb, and Class III.

Similarly, the 2017/745/EEC Medical Device Regulation (MDR) also classifies medical devices into risk categories, including Class I, Class Is, Class Im, Class Ir, Class IIa, Class IIb, and Class III.

In both regulations, Class I medical devices are subject to CE Marking, while other classes (Class IIa, Class IIb, and Class III) undergo the CE Certification process.

CE Marking

The responsibility during the process lies entirely with the manufacturer and the Medical Device Manufacturer obtains the right to affix the CE marking to their products by preparing their Technical Files together with the necessary studies in accordance with the ISO 13485 Quality Management System establishment and the relevant directive/regulation.

CE Certification

In the processes, a CE Certification process is carried out based on the conformity of all relevant work carried out with the documentation audits to be carried out by the Notified Body, both in the field and in relation to the work carried out, by the Notified Body, taking responsibility together with the Medical Device Manufacturer.

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