You must have a CE Marking of conformity to sell medical device throughout the European Union.
Medical device legislation, such as EU MDR 2017/745 and ISO 13485:2016, can be tricky to comprehend but is critical to the success of life science organisations. Failure to adhere to these requirements may result in manufacturers stopping manufacturing entirely.
What is CE Marking?
A CE Mark is your certification that your product meets the Essential Requirements of the relevant European Legislation. You will have immediate access to all EU and EEA markets, as well as any other international markets where CE Marking is approved. The following product categories applies to at least one of the CE marking directives:- Medical devices
- Active implantable medical devices
- In vitro diagnostic medical devices
What does ‘CE’ mean?
CE is an abbreviation of the French phrase ‘Conformité Européene’ which translates as ‘European Conformity.’ The official, correct term is ‘CE Marking’ and this is what is used in the various product directives.
What does CE Marking mean?
The CE Marking acts as a manufacturer's certification that their product meets the essential requirements of the relevant European health, safety, and environmental legislation outlined in the many product directives. When a product has CE Marking,
- it is free to move within the European Free Trade Association (EFTA) and the European Union (EU).
- It also means that customs and other enforcement authorities are permitted to seize non-conforming goods.
- Proves your device complies with essential legal requirements
- Allows commercialization across all 30 countries in the EEA
- Demonstrates your device meets safety and quality standards
- Provides credibility to your organization in the eyes of your patients and customers
- Demonstrates you have implemented a QMS and can maintain documentation quality
What products need CE Marking?
The method of determining if a product requires CE Marking is somewhat complicated. Manufacturers must establish the following:
- What countries they want the product introduced in. Countries within the European Economic Area (EEA) or EFTA will require CE Marking if the goods are covered by one or more of the CE Marking directives.
- If Turkey is a potential market. Despite not being a member of the EU or the EEA, Turkey has implemented a number of the CE Marking Directives, which means that many items here will also require CE Marking.
In summary
CE marking allows free movement and sale of goods throughout the European Economic Area. For you to grow your business and distribute your products in the European market, CE-marking is mandatory for many products.
CE marking is a type of standardized marking that ensures the product is being manufactured as per the EU’s directives and regulations. Having CE marking is not only a regulatory requirement but also one customers look for. Nowadays, customers research every aspect of the products, including quality and compliance with safety regulations before purchasing.
Did you know?
We are able to support you with achieving CE Mark certification as part our full-service medical kitting solution.
Schedule a meeting with a representative to see how we can help your business achieve CE Marking
