The recent implementation of EU MDR has resulted in numerous changes to the certification process of CE marking. There are more regulations to meet, making the procedure more complicated and time-consuming.
Avoid a situation in which the only thing preventing you from launching your Medical Device Technology to the marketplace is the continuing certification of CE marking certification. You need to understand when to start this process as well as how to incorporate it into your entire business strategy.
In this post, we will look at the guidelines of the CE mark medical device process and how to optimize and plan the process to avoid potential congestion.
Since the EU MDR 2021 May implementation, the software has been designated as an effective medical device. The CE marking is necessary for every Medical Device Software supplied to the Marketplace. Otherwise, it will be unable to be marketed within the EU.
How to Obtain CE Mark medical device in the EU
Whether you outsource the production process or not, as a Medical Device Application manufacturer, you are accountable for providing CE marking.
In general, the method of getting CE certification is determined by the class of medical device. Since Medical Device Application is considered an appropriate medical device under the EU MDR, it falls to at least class IIa.
According to EU MDR guidelines, medical devices from classifications III, IIa and IIb, must undergo conformity testing by a Recognized Body.
A 3rd-party organization that has been accredited by an EU Competent Authority to assess medical device technical documents in accordance with medical rules and harmonised standards is known as a notified body. As a medical device maker, you can choose which Notified Body will conduct the assessment on your behalf.
The steps for acquiring CE mark medical device
• Implementation of an efficient management system
• Technical file preparation
• Registration of the manufacturer in the DATABASE of EUDAMED
• Notified body audit
• Giving the certificate of CE marking
• Declaration of the conformity
• Medical device software registration in the EUDAMED DATABASE
By following the above steps, you will be assured of getting the CE mark medical device.