MDR Compliance
CE marking is not a quality mark, but a declaration that your medical device meets the essential safety and performance requirements outlined in the EU Medical Device Regulation (MDR 2017/745). Compliance with the MDR ensures that your medical device is safe, effective, and suitable for its intended purpose within the European market.
CE marking process for medical devices:
Below is an overview of the key steps in the CE marking process for medical devices:
1. Confirm Product Qualification
Determine whether your product qualifies as a medical device under the MDR’s definition.
2. Classify Your Device
Identify the correct risk classification of your device (Class I, IIa, IIb, or III). This impacts the conformity assessment procedure.
3. Implement a QMS
Most manufacturers adopt ISO 13485 to meet the QMS requirements specified in the MDR.
4. Compile a Technical File
Prepare comprehensive technical documentation demonstrating your device’s conformity with applicable requirements.
5. Conduct a Clinical Evaluation
Create a Clinical Evaluation Report (CER) in accordance with MEDDEV 2.7/1 Rev. 4 and MDR Annex XIV.
6. Appoint a EU-REP
If your company is based outside the EU, you must appoint an EU Authorised Representative to act on your behalf in all regulatory matters within Europe.
7. Undergo Conformity Assessment by a Notified Body
For most devices (excluding non-sterile, non-measuring Class I devices), a Notified Body must audit your QMS and review your technical documentation.
8. Obtain Certificates
Upon successful assessment, you will receive: - CE Certificate from the Notified Body - ISO 13485 Certificate (if applicable)
