CE Marking

Europlaz can apply for a Class I or IIa CE Mark on your behalf.

As part of the overall ‘Concept to Completion’ service, Europlaz can provide support and assistance with the Regulatory / CE Marking processes ranging from individual Technical File elements to managing the complete CE Marking process including the generation and maintenance of the Technical File and supporting documentation.

In order to apply a CE Mark to a medical device, it is necessary to demonstrate that the device meets the requirements in the appropriate Medical Device Directive / Medical Device Regulation by carrying out a comprehensive conformity assessment.

Click here to see our comprehensive list of all the medical device regulations you need to know about in 2021.

Determine the Risk Classification the Product falls into

The Medical Device Directive / Medical Device Regulations detail the Rules for determining the classification of the product. These classification rules are based on risk and include examples of factors that influence the associated risk.

There are four classification categories: Class I is the lowest risk category; Class IIa is considered low to medium risk; Class IIb is medium to high risk and Class III is the highest risk category. In addition, there are 2 sub-classes for Class I:  Class I devices that are sterile and Class I devices that have a measuring function.

Find out more about the changes to risk classifications here in 2021

Determine the appropriate Conformity Assessment Procedure

The Annexes of the MDD / MDR details the various procedures for demonstrating conformity and it is the responsibility of the manufacturer to choose the appropriate procedure based on the classification of the product. The choice of assessment route dramatically affects the complexity and scope of the assessment. This is why an accurate classification of the device is a critical upfront step in the assessment process.

Implement Post-Market Surveillance

In order to ensure that incidents are assessed and where applicable reported to the national competent authority and to review information gained in the post market phase, a Post Market surveillance system must be implemented.