CE Marking for Medical Devices
CE Marking is the final and mandatory step for placing a medical device on the European Economic Area (EEA) market. This mark certifies that the product complies with all safety, performance, and quality requirements set out in the European regulations — MDR (Regulation (EU) 2017/745) and IVDR (Regulation (EU) 2017/746).
We provide specialised assistance throughout the entire CE Marking process, from the initial planning phase to submission and approval by the notified body (where applicable).
Our support includes
- Assessment of the appropriate regulatory pathway based on the device class and type
- Preparation and organisation of the technical documentation required for conformity assessment
- Support in interactions with notified bodies, including audit preparation and clarification of non-conformities
- Drafting of the EU Declaration of Conformity
- Guidance on labelling, IFU (Instructions for Use), and standardised symbols
- Ongoing support until CE Marking is obtained
How does the process differ depending on the device class?
Class I (Low Risk)
The process is typically self-declared by the manufacturer, without the involvement of a notified body (except for devices that are sterile, have a measuring function, or are reusable surgical instruments).
We assist with structuring the technical documentation, preparing the Self-Declaration of Conformity, and verifying applicable regulatory requirements.
Class IIa and IIb (Moderate to High Risk)
These devices require assessment by a notified body before being placed on the market.
We provide support with the preparation of technical documentation, communication with the notified body, audit readiness, and handling of any non-conformities, if applicable.
Class III (High Risk)
Devices subject to the most stringent level of assessment, including detailed review of clinical, technical, and manufacturing documentation.
We support the entire process, including the development of the Clinical Evaluation Plan (CEP) and scientific review by the notified body, ensuring that the submission meets the highest regulatory standards.
With our support:
- The likelihood of success at the first submission is significantly increased;
- Time and costs associated with corrections and delays are reduced.
We offer end-to-end support for obtaining CE Marking, tailored to the device class and corresponding regulatory route.
