8 things to know about CE approval process for Medical Devices

As a medical device manufacturer which wants to place its product on the European market, you must be aware of all requirements to do so. Of course, one of the first things, you need to comply with Europe’s Medical Device Regulation (MDR).

There are few ways to do so, and it’s known as conformity assessment routes.

We will bring you closer to the terms of each of these 8 points.

1. Determination EU Medical Device Directive which applies

A medical device classification system is therefore needed, in order to apply to a medical device an appropriate conformity assessment procedure.

2. Device Classification

All CE marking directives require medical device manufacturers to choose a suitable route to conformity assessment. It will partially determine the route. They need to create and make available every technical documentation. It must show your product’s conformity to the requirements of the applicable directive.  From directives and regulations, it depends on what kind of information you have to keep, and for what period of time you have to keep it.

3. Implementation of QMS

Eu declaration of conformity requires the establishment of a documented QMS. When starting to implement the new requirements to your QMS, we suggest you update your Quality Management system to be compliant with the latest version of ISO 13485:2016, if you have not done this earlier. This is because meeting the requirements of ISO 13485:2016 can actually help you to meet the new MDR requirements as there is better alignment between the requirements of the standard and the new regulations.

4. Technical File Preparation

By now you know the Class of your medical device. The medical device manufacturer has the responsibility to develop a technical File. It needs to contain all the steps that were taken to comply with CE requirements.

5. Authorized Representative Assignment

The final steps in the CE marking process include affixing the mark to your product and signing a Declaration of Conformity. The declaration acknowledges that the manufacturer is solely responsible for the compliance of their product with all applicable CE marking directives.

6. Notify Body audit

Typically, Notified Bodies determine the level of the conformity of medical devices and the associated quality systems for manufacturers that seek to sell products in Europe.

The medical device manufacturer confirms the classification with a Notified Body of their choice. If there is uncertainty or disagreement between the manufacturer and the Notified Body, the matter must be referred to the Competent Authority for decision.

7. CE marking certificate

For all devices except Class I (non-sterile, non-measuring), you will be issued a European CE Marking Certificate for your device and an ISO 13485 certificate for your facility following the successful completion of your Notified Body audit. ISO 13485 certification must be renewed every year. CE Marking certificates are typically valid for 3 years.

8. Affixing the CE mark and Declaration of Conformity

The final steps in the CE marking process include affixing the mark to your product and signing a Declaration of Conformity. The declaration acknowledges that the manufacturer is solely responsible for the compliance of their product with all applicable CE marking directives.

Additional:

• All Class I devices must be registered with the Competent Authority where your European Representative is based
• Some EU Members require additional registration of Class IIa, IIb or III devices which are placed on their markets
• For Class I (non-sterile, non-measuring), CE Certificates do not expire. You must perform CER Updates and PMS activities.

Note:

All devices will require clinical data. Most of these data should refer to the subject device. Clinical studies are required for Class IIb and III implants. Existing clinical data may be acceptable. Clinical trials in Europe must be pre-approved by a European Competent Authority.

If you prepare yourself and take the required steps to appropriately certify your products, it’s almost impossible to fail.