This is what you should know when applying for CE Mark
What is it? It’s a certification mark as proof of conformity with health, safety, and environmental protection standards. In this case, we talk about medical devices that are sold in the EU.
What it stands for? It comes from the French phrase “Conformité Européene” which means ‘European Conformity.’
Is it a must? It’s is considered an economic offense in case of trying to sell a medical device without the CE mark. Be aware, it’s fined differently by each country of the EU.
Medical Devices divided into classes
Are all medical devices treated as same? No. All medical devices fall into one of four basic categories. Categories are based on the recognized risk of the device to the patient or user.
How to identify your medical device? There are more than 20 product Directives and regulations. You then need to apply the scope to your product to establish which ones apply. Every Directive has a number ‘must’ requirements which medical device has to meet.
Importance of QMS
Is the implementation of QMS necessary to produce your medical device? Yes. Part of MDD and MDR requires ISO13485. It is designed to respond to the latest quality management system practices, including changes in technology and regulatory requirements.
About what you should be considered? You should be careful while creating and maintaining technical documentation (or a technical file). Those documents should show that your medical device complies with assessment procedures. You must keep it up to date. It’s necessary to pay attention when device is modified or it falls under updated conformity assessment procedures. The technical file can be made available in any format (i.e. paper or electronic).
What is happening after the Technical File is ready?
So, when you as a Medical Device creator are satisfied with your product that conforms to the applicable CE Marking Directives, you must complete a Declaration. Requirements for Declaration include things like name and address of the manufacturer, details of the product, statement, signature, etc. Declaration of conformity must be a standalone document that you attach to the Technical File.
And what’s next? Affixing the CE mark in accordance with requirements from MDD/MDR. It should be affixed on the medical device itself or to its data plate. Sometimes it’s followed by the identification number of a notified body below, in case NB has been involved in the production phase of the medical device. Sometimes more than one NB is involved, where more than one directive is applicable.
Keep in mind, if you have a QMS software it’s much less hassle to get you through all these documentation and to help you get your CE mark faster.