How to utilize ISO 13485 to acquire a CE Marking on your Medical Device.
What is a CE Marking?
The (CE) mark stands for “Conformité Européene”, meaning European Conformity. Since 1985, the CE marking has distinguished products as compliant under European product safety legislation.
This marking is important because it allows consumers to identify whether or not a manufacturer, importer, or party responsible is following compliant processes based on their ability to provide appropriate technical documentation of manufacturing.
Before any product can be sold on the European market, it must be affixed with the CE Mark. The mark indicates that a product:
- Complies with the European Union’s New Approach Directives.
- Meets all safety standards and performance requirements.
- Satisfies its purpose without endangering lives or property.
Why you should know the EU’s New Approach Directives?
The New Approach Directives not only apply to products manufactured within Europe, but also for products that are internationally imported and designated to be sold within the European market.
CE marking is mandatory for products that fall under one of the 25 CE Directives or Regulations. When a product is not covered by one of these Directives or Regulations, affixing the CE mark is forbidden. Often, more than one Directive or Regulation can be applicable to a product.
CE marking is not required for products such as pharmaceuticals, chemicals, cosmetics, and food.
Benefits of CE Marking
- Free movement of goods
- Transportation of products within the member states of the European Union is not limited by any restrictions.
- High level of health, safety, and environmental protection
- Because products meet the requirements of European "New Approach" Directives, products have a high level of health, safety, and environmental protection.
Steps to Acquire CE Marking
Reading about all the benefits this mark can give your medical device can make you wonder how many obstacles there are? We have created a step-by-step guide for your device to achieve a (CE) marking.
| Step | Description |
| 1) Identify Device’s Class Category |
As a medical device manufacturer or importer in the European market, you must identify the class of the device according to the associated level of product risk into.
|
| 2) Assess Directives that Apply to Device |
Make sure to inspect that your device complies with the requirements of applicable EU directives:
|
| 3) Preserve Technical Files of Manufacturing Stage |
There must be proper documentation demonstrating evidence for every manufacturing stage:
|
| 4) Ensure Product Conformity Assessment |
Your device’s class type (Step 1) will determine the review path(s) it will take to achieve conformity. The review paths include the following:
|
| 5) Approve Declaration of Conformity |
Once the conformity assessment is complete and all qualifications are documented (technical files), the device is deemed compliant and is ready to receive a CE marking. |
ISO 13485:2016 is an international standard for Quality Management Systems (QMS) of medical device manufacturers and providers. You can read more about it here, ISO 13485:2016.
Since the scope and embodiment of review is heavily influenced by the the selection of review path, it can be beneficial to have a Quality Management System cover most of the review routes before the assessment even takes place. Most of the European "New Approach" Directives are met by a compliant ISO 13485 QMS. A Quality Management System can help simplify the technical documentation process during each manufacturing stage.
Companies with an implemented QMS have seen a notable difference in obtaining CE mark for their products.
Do you have a QMS?
Obtaining a CE Marking can be a difficult process, especially without the proper tools! You can be more prepared to overcome the regulatory process of CE Marking with Sierra's Quality Management System, also compliant with ISO 13485.
Sierra Quality Management System (QMS) offers you a robust start to conquering a CE marking for your medical device. Sierra’s QMS will help you optimize the technical documentation processes behind every step avoiding any setbacks (and disadvantages) for your business.
Sierra QMS is designed for organizations that are looking to market medical devices in a global regulated environment. It is built for engineering teams to operate with their preferred tool-sets while automating compliance with medical device QMS principles for global markets.
Want to see how Sierra QMS can help your Medical Device CE certified?
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