An Introduction to CE-Mark
Benefits of CE-Marking
CE-Mark for Non-Medical Devices
CE-Mark for Medical Devices
An Introduction to MDR (Medical Device Regulation)
Steps of CE-Marking for Medical Devices
An Introduction to CE-Mark
Products with CE Mark are allowed to enter the European Economic Area (EEA) markets including Austria, Belgium, Bulgaria, Czech Republic, Cyprus, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Liechtenstein, Luxembourg, Malta, Norway, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Great Britain and Croatia, the Netherlands and Poland. “CE” stands for “Conformité Européene” which means European conformity. CE marking is one of the basic prerequisites for entering the European market and exporting products to these countries.
The CE certification includes a statement or a declaration of conformity provided by the manufacturer stating that the product meets the basic criteria of the European Union, e.g. the EMC (Electromagnetic Compatibility) Directive and the like.
Government officials usually pay attention to this mark on imported products. Because this sign indicates that the legal requirements for the import of this product have been met. This process prevents the reluctance of unauthorized products and monitors the quality control of imported products.
Benefits of CE-Marking
In addition to improving the design and production processes of the product and other product realization processes, CE-Marking plays an important role in improving the quality and safety of the product. The other benefits are as follows:
- Unrestricted export to European countries and increase of revenue
- Facilitating export to non-European countries through reduced product inspection
- Increase of consumer trust
- Receiving product conformity certificate to demonstrate the compliance with EU regulations and standards
CE-Mark for Non-Medical Devices
The EU requirements are as follows:
- Product description
- Manufacturer’s or its EU authorized representative’s profile
- Product identification and classification
- Product Declaration of Conformity including:
- Product photos and other reviewable documents
- EU Directive applied
- List of harmonized standards
- Name, Title and signature of a senior level management member representing the company
CE-Mark for Medical Devices
The following items are required:
- Implementation of Quality Management Systems (ISO 9001 and ISO 13485)
- Implementation of risk management (ISO 14971)
- Product compliance to MDR
An Introduction to MDR (Medical Device Regulation)
The Medical Equipment Regulation (MDR), is a set of requirements set by the European Union (EU) for all medical devices. All products of the Medical Device Group must comply with this Regulation throughout the EU. Therefore, one of the requirements for the export of medical devices to many countries, including European countries, is the compliance of the product with the criteria imposed by MDR. Since 2021, MDR requirements have replaced the previous MDD (Medical Device Directive) requirements. All companies in the field of medical device manufacturing that wish to receive CE-Mark for the export purposes to EU countries shall comply with this regulation.
The purpose of MDR is as follows:
- Improving the patient safety through emphasizing on clinical evaluations (CER), post market surveillances (PMS, PMCF, PMPF) and risk management
- Expanding the definition of medical devices to products that were not previously included or had different rules. Furthermore, new classification rules have also been introduced based on the risk class of products.
- Improving conformity assessment by applying stricter procedures that require the participation of notified bodies. These are independent bodies determined by the European Union (EU) members to assess the compliance of medical devices with legal requirements.
- Introducing a unique device identification (UDI) system which is used to increase product tracking criteria and facilitate future monitoring. This unique code is required to be registered in the European Database on Medical Products (EUADAMED).
- Providing comprehensive evidence of performing clinical and supplier’s evaluations to confirm the safety and performance of medical devices, especially for high risk products.
Steps of CE-Marking for Medical Devices
- Determination of product risk class
- Determination of EU authorized representative
- Designating the company representative
- Implementing risk and quality management
- Providing product technical file
- Providing clinical evaluations
- Registering the company and product on EUDAMED website
- Designating NB and receiving the required credentials
- Providing Declaration of Conformity
- Receiving and using of CE-Mark
- Performing post market surveillances
