It is required to apply or obtain a CE mark for your product to sell/deal with a medical device in the EU (European Union). The main implication that CE mark medical device show is that your device is per all EU regulations.
Therefore, it is easy and possible to commercialise your products or devices in all 32 EU countries. The medical device manufacturer must work under applicable regulations by getting a CE mark medical device regardless of whether it was manufactured locally or outsourced.
There are offices across Europe that can help you when you need to obtain CE mark medical device. Because of that, it is essential to start by getting a CE mark for your medical device before selling your products in the EU.
Process of obtaining CE mark medical device
This mark is not a standard quality mark. However, it shows compliance with your product type’s EU-specific performance standards, efficacy, safety, and quality. Medical device manufacturers need to follow the CE mark approval process for their medical devices as per the current regulations. The steps for obtaining CE mark medical device include:
1. Evaluate all EU directives and determine the one that applies to your medical device.
2. Determine your device classification.
3. If applicable, implement a good quality management system on your device.
4. Prepare a design dossier or a CE marking technical file.
5. Prepare CER (clinical evaluation report).
6. If you are not a European resident, look for an authorised European representative.
7. Have your Design Dossier/technical file and QMS audited by the Notified Body. It is not applicable if your device is not sterile, has no measuring function, and is class l.
8. Obtain a CE mark for your medical device from the Notified body.
9. Prepare DoC (Declaration of Conformity). Know the state that your device complies with the right Directive.
What is CE mark?
CE marking is a legal requirement for the manufacturer to place their medical devices on the EU market and a claim that a particular product meets performance requirements and general safety (GSPR) of relevant EU medical device regulations.