CE marking is a mandatory requirement of the European Union for the introduction of medical devices, personal protective equipment, and in vitro diagnostic medical devices into the European market. The CE marking process ensures conformity with specific directives or regulations, and it can be achieved through a manufacturer’s declaration or by undergoing an assessment by a notified body, depending on the risk class of the product.

Before placing on the market

In order to place a product on the market within the European Union, a number of requirements must be met, which are set out in European directives or regulations. The detailed requirements appear already at the design stage, through production, quality control and product registration.
Verification of Qualification and Classification
Ensuring the accurate qualification and classification of a medical device is vital for determining the appropriate conformity assessment procedure. This precision helps prevent legal complications and minimizes additional costs.
Analysis of Harmonized Standards
The identification and execution of required tests in alignment with harmonized standards enable the evaluation of product effectiveness and safety for use.
Risk Management and Analysis
To bring a product to market, it is essential to identify, assess, and evaluate the associated risks. Additionally, monitoring the effectiveness of the risk management process is crucial.
Clinical trials of medical devices
on the EU market in accordance with the MRD (Regulation (EU) 2017/745 on medical devices.
Preparation of Technical Documentation
Thoroughly prepared technical documentation is essential to ensure compliance with the comprehensive safety and performance requirements of the medical device.
Verification of Technical Documentation
Ensuring that the technical documentation aligns with the relevant legal requirements is a crucial step before initiating the certification or notification process.
Selection and Contacting a Notified Body
A critical step involves choosing a notified body that is appropriate for certifying the manufacturer's products based on factors such as classification, specific codes, and conformity assessment procedures.
Product Registration CA | EUDAMED
Before introducing a medical device or in vitro diagnostic medical device to the market, it is necessary to register or notify the pertinent Competent Authority or EUDAMED.
Medical Device Labeling
The labeling of medical devices is a pivotal aspect of regulation and oversight within the European Union, with the primary objective of ensuring patient safety, as well as the effectiveness and quality of medical devices. Labeling assumes a critical role in the conformity assessment process and contributes significantly to the identification and traceability of medical devices in the EU market.

After placing on the market

Following successful completion of the product conformity assessment process, the Manufacturer shall ensure that the surveillance and control activities for the manufacture of the devices, as well as the related post-market surveillance and observation activities, are carried out in a manner consistent with the current legal status.

  • Post-Market Surveillance (PMS)

As a component of market surveillance, it is crucial to establish and routinely update procedures for actively collecting and reviewing the post-marketing experience gained.

  • Vigilance

Vigilance involves the identification of medical incidents and events, as well as the implementation of corrective actions related to device safety.

  • Certificate of Free Sale

The certificate of free sale is a document that streamlines the export of medical devices and in vitro diagnostic medical devices from the European Union to other regions.