The CE marking is mandatory for products manufactured anywhere in the world that want to be marketed in EU member countries. It serves to access the European market and guarantee the free movement of products in the European Economic Area (EEA). It helps to quickly and easily identify products that comply with the obligations of the European Union legislation.

The CE marking is a conformity marking in which the manufacturer / importer evaluates the product and informs users and authorities that it meets the safety, health and environmental protection requirements demanded by the EU.

A product without CE marking cannot be sold, unless it is a custom-made medical device (for example, custom-made orthopedic products) or those intended for clinical research (with subjects or patients who have signed their informed consent).

At MedDeviceCorp we help you obtain the CE marking.

Benefits of CE markingBoth employees and customers benefit from the CE marking of medical devices:Minimize the risk of withdrawal in the EU . Products with CE marking cannot be rejected in EU countries with legal justification of the standards.It enables free circulation and commercialization in the countries of the European Union. It is recognized globally in the rest of the markets.Trusted CE marking . It means minimizing delays in the launch of your product, which entails high costs both for the manufacturer and for the patients who need that care.Confidence and security to customers . The CE marking assures the customer that the product to be consumed is safe.It guarantees compliance with the functionality, durability, environmental protection and energy saving requirements common in Europe.How we request the CE Marking

To request the CE marking for medical devices, we follow the following steps:

Demonstrate product compliance with essential requirements. It is applicable to all products, regardless of their classification. It involves demonstrating the conformity of the product with the essential requirements through clinical data. The company must also provide for each product the monitoring plan after marketing.Confirm what product classification it is. Confirm the classification of the medical device, to obtain the marking as soon as possible.Choose an evaluation procedure . Depending on the product class, the procedures for conformity assessment are established (they are not specified). As the necessary documentation is prepared to verify the CE marking of medical devices, you generate the documentation that meets the requirements of the ISO 13485 quality management system for medical devices.Achieving the ISO 13485 certification and at the same time the CE Certification,Regulatory Affairs Consultant supposes a smaller effort when fulfilling common requirements simultaneously. However, becoming certified to ISO 13485 is not mandatory, but it facilitates international expansion and demonstrates the organization's commitment to quality standards.

In case of the first request from a company , it has additional requirements such as the quality manual of the company.

Healthcare product consulting

As technical advice specialized in medical devices and the cosmetic industry, we can help you with our services:

ISO 13485 certified to achieve ISO 13485 certification for medical devices, medical devices and related services.CE marking of medical devices . We process the CE marking of your health products, medical devices and related services.ISO outsourcing . Outsource the tasks as responsible for the ISO 13485 certificate of medical devices, we take care of everything you need.