What is the CE mark and what is it for?
The CE marking is mandatory for medical devices manufactured anywhere in the world that are intended for marketing in other EU member states. It serves to access the European market and ensure the free movement of products within the European Economic Area (EEA). It helps to quickly and easily identify products that comply with the legislative requirements of the European Union.
The CE marking for medical devices is a conformity marking in which the manufacturer/importer assesses the product and informs users and authorities that it complies with the safety, health and environmental protection requirements required by the EU.
A product cannot be sold without the CE marking, unless it is a custom-made medical device (such as bespoke orthopaedic products) or one intended for clinical research (with subjects or patients who have signed their informed consent).
At EmasConsultors, we help you obtain the CE marking, regardless of the class of your medical device.
Benefits of the CE marking for medical devices
Both companies and customers benefit from the CE marking of sanitary products:
- Minimise the risk of a recall in the EU. Products with CE marking cannot be rejected in EU countries on the grounds of legal non-compliance with standards.
- It enables the free movement and marketing of products in European Union countries. It is also globally recognised in other markets.
- A mark of trust. The CE marking minimises delays to your product’s launch, which can incur high costs for both the manufacturer and the patients who need it.
- Confidence and safety for customers. The CE mark assures the customer that the product is safe.
- It guarantees compliance with the requirements for functionality, durability, environmental protection and energy saving, which are common across Europe.
How do we apply for the CE mark?
To apply for the CE mark for medical devices, we follow the steps below:
- Demonstrate the product’s compliance with the essential requirements. This applies to all products, regardless of their classification. It involves demonstrating the product’s conformity with the essential requirements through clinical data. The company must also provide a post-market surveillance plan for each product.
- Confirm the product’s classification. Confirm the classification of the medical device to obtain the CE marking as soon as possible.
- Choose an evaluation procedure. Depending on the product class, the procedures for conformity assessment are established (not specified). As you prepare the necessary documentation to verify the CE marking of medical devices, you generate the documentation that complies with the requirements of the ISO 13485 quality management system for medical devices. Achieving ISO 13485 certification and the CE marking at the same time involves less effort in meeting common requirements simultaneously. However, certification to ISO 13485 is not mandatory, but it facilitates international expansion and demonstrates the organisation’s commitment to quality standards.
- Formalise the application with the General Register of the Notified Body (AEMPS – Spanish Medicines Agency). The Notified Body ensures that medical devices comply with the requirements of European Directives and Regulations. This involves submitting the technical documentation, the signed application forms and proof of payment of the relevant fees.
In the case of a company’s first application, additional requirements apply, such as the company’s quality manual.
Sanitary products consultancy
As a specialised technical consultancy for sanitary products and the cosmetic industry, we can assist you with our services:
- ISO 13485 Certification to achieve ISO 13485 certification for sanitary products, medical devices and related services.
- CE marking for medical devices. We handle the CE marking for your medical devices, related services and products.
- ISO Outsourcing. Outsource tasks such as the responsibility for the ISO 13485 certificate for medical devices. We will take care of everything you need.
- Medical device training to meet your company’s needs, available as ‘In-Company’, ‘Online’ or a blended format.