Entering the European market presents hurdles that may cause delays in the introduction of your product. Delays like these can be costly for both the company and the patients who need care.
However, there are strict criteria in place to assure the safety of users and patients and the device’s functionality.
You must apply or obtain CE Marking for your medical equipment to sell it in the EU(European Union). CE Mark medical device certifies that your device conforms with EU standards and allows you to sell your products across Europe.
Whether you export any or all aspects of your manufacturing business, you are accountable for maintaining compliance requirements and obtaining a CE Mark medical device as a licensed medical device manufacturer.
How to get your CE mark medical device in Europe
Although CE is not primarily attributable, it does require you to achieve specified performance, quality, efficacy and safety standards for your product category to comply with EU Directives.
Below are the basic steps for medical device approval in European CE
• Choose the EU Directive that applies to your equipment.
• Determine your device’s classification.
• If your device requires it, set up a quality management system.
• Prepare a Technical File for a Design Dossier or CE Marking.
• Make a report on the clinical evaluation.
• If you don’t have a physical presence in Europe, choose and designate a European Advisory Body to work on your behalf inside the EU.
• Unless your equipment is Class I, non-sterile, and has no measurement function, have your Technical File/Design Dossier and QMS inspected by a Recognized Body.
• Your Notified Body should provide you with certificates of CE Mark medical device and ISO 13485.
• Make a Do(declaration of Conformity) stating that your equipment complies with the relevant Directive.
What is the duration of a CE certificate?
CE certificates provided by Notified Bodies are normally valid for 3years under the present system. For some high-risk equipment, the time frame may be as short as one year. Your CE certification, on the other hand, is contingent on keeping your quality management systems certification.