How to Obtain CE Marking for Medical Device
While “CE” is not a quality mark, compliance with the EU Medical Devices Regulation (MDR 2017/745) requires you to meet certain standards for performance, quality, safety and efficacy specific to your product type. MedDevice's comprehensive guide outlines the current European CE approval process for medical devices. However, obtaining CE marking for medical devices usually involves the following steps:
- Determine whether your product meets the definition of a medical device as defined in the MDR.
- Determine the European medical device classification for your medical devices.
- Implement a Quality Management System (QMS). Many companies use ISO 13485 to meet these requirements.
- A CE Marking Technical Documentation needs to be prepared.
- A Clinical Evaluation Report (CER) should be prepared in accordance with MEDDEV 2.7/1 rev4 and MDR guidelines.
- If you do not have a physical presence in Europe, you must select and appoint a European Competent Representative (EC REP) to act on your behalf within the EU.
- Unless your device is Class I, non-sterile and does not carry a measurement function, it must be audited by a Notified Body for QMS and Technical Documentation.
- CE certificate for medical devices must be obtained from your designated Notified Body.
- An EU Declaration of Conformity (DoC) must be prepared confirming that your device complies with the regulations set out in the MDR.
MedDevice Can Help You Obtain CE Marking for Your Medical Device
The MDR CE marking approval process will vary depending on the class of the medical device according to EU MDR 2017/745. CE marking approval includes several other elements such as product quality, technical dossier submission to the Notified Body, clinical evaluation and so on.
Our Service Scope
- Assisting medical device classification
- Validate applicable standards and test requirements
- Compile technical documentation or review existing documentation
- Review the compatibility and consistency of marketing materials, labels and user manuals
- Ensuring compliance with the Essential Requirements
- Prepare Clinical Evaluation Reports with the clinical data provided
- Implement, adjust and maintain the quality system (usually ISO 13485) to comply with European and international criteria
- Perform risk assessment and management in accordance with ISO 14971
- Develop surveillance and post-market monitoring procedures.