There’s a common misconception among many medical device manufacturers that obtaining a CE mark is now too hard, too costly, and too complicated. But with the correct guidance and knowhow, obtaining your CE mark can be an uncomplicated process.
1. Determine which EU Regulation applies to your device: Medical Devices Regulation (EU MDR 2017/745) or In Vitro Diagnostic Devices Regulation (EU IVDR 2017/746).
2. Determine the classification of your device.
3. Identify relevant European Harmonized Standards.
4. Implement a Quality Management System (QMS), if applicable to your device. Most companies use ISO 13485:2016 to meet the requirements.
5. Prepare a CE Marking Technical Documentation or a Design Dossier.
6. Prepare a Clinical Evaluation Report (CER) or Performance Evaluation Report (PER) according to MEDDEV 2.7/1 rev4 and MDR and IVDR.
7. Appoint a European Authorized Representative (EAR) to act on your behalf within the EU if you have no physical location in Europe.
8. Audit and Certification by a Notified Body (NB) of the QMS and Technical File/Design Dossier if device is a Class III, Class IIB, Class IIA and Class I device with sterile and/or measuring function. All other Class I devices are exempt from NB audit.
9. Obtain approval to affix CE Mark and ISO 13485 certificate from your Notified Body, unless you are Class I and can self-certify your product.
10. Prepare a Declaration of Conformity (DoC), which states that your device complies with the appropriate Regulation.
11. Register with Competent Authority (CA) the EU state where you have a legal entity or where your designated authorized representative is based. There are also additional national provisions in order to introduce a medical device into specific EU countries.
If you need any assistance developing or reviewing your Technical Documentation, AKRN Experts are happy to help you! Please consult with our experts to find a solution that fit your needs.